Atriva Therapeutics to Speed up Development of COVID-19 Drug with Federal Funding

  • German Federal Ministry of Education and Research (BMBF) awards Atriva up to €11.4 million for the clinical development of a drug to treat COVID-19
  • Product candidate ATR-002 could help hospital patients with COVID-19 avoid ventilation and intensive care treatment
  • Targeting RNA viruses and acting in the host cell, drug candidate can retain full activity even with SARS-CoV-2 variants
  • Therapeutic aims to inhibit replication of virus and to prevent overshooting immune response
  • Tablet can be administered easily

 Tübingen (Germany), April 21, 2021 – Atriva Therapeutics GmbH, a company that is pioneering the development of therapies for the treatment of viral infections, has secured up to €11.4 million in federal funding. The company, founded in 2015, announced today that it was selected for research funding from the German Federal Ministry of Education and Research (BMBF). Atriva will use the funds to advance its drug ATR-002 towards market maturity as quickly as possible. “We are delighted our work has been recognised by the panel of experts around Prof. Dr. Ciesek and Dr. Spinner,” says Atriva’s CEO Dr. Rainer Lichtenberger. The funding is part of a €50 million BMBF programme for COVID-19 therapies, awarded to a total of eight companies.

“The late clinical development stage, the pivotal Phase III trials in particular, and the manufacturing preparations for the drug are very expensive. Finding the respective financing is difficult for small biotech companies,” explains Atriva’s CEO Dr. Rainer Lichtenberger. “Especially in such a global health crisis as this, a broad public funding initiative is extremely important and can be decisive for speeding up the drug development process – as has been impressively demonstrated with the SARS-CoV-2 vaccines.”

ATR-002 is currently in a Phase II clinical study called RESPIRE.[1] It is suitable for COVID-19 patients with moderate to severe symptoms who are hospitalised but do not yet require ventilation or intensive care. The RESPIRE trial aims to evaluate the efficacy and safety of the drug candidate in 220 adults; the first patient was treated in mid-April. A Phase I trial to assess safety and tolerability has already been successfully completed.

The fight against the pandemic not only requires vaccines, but also effective and safe drugs to treat patients suffering from the different stages of COVID-19. “We believe ATR-002 has great potential here because it aims to not only inhibit the replication of the virus but also to prevent an excessive immune response,” Lichtenberger says. “This often causes severe progression of the disease.” ATR-002 acts in the host cell and is most likely not prone to a loss of effectiveness in virus mutations such as B.117, B.1.315 and P.1.

Should the current clinical trial lead to good results and conditional approval from regulatory authorities, the new funding would help Atriva bring the drug to the patient faster.

About ATR-002’s mode of action with dual benefit

Atriva’s lead product ATR-002 is developed specifically to treat diseases such as influenza and COVID-19, caused by RNA viruses. ATR-002 is a clinical stage MEK inhibitor drug candidate targeting the intracellular Raf/MEK/ERK signaling pathway. This pathway is central for replication of many RNA viruses, such as the influenza virus, hantavirus or respiratory syncytial virus (RSV) and also SARS-CoV-2, the virus that causes COVID-19. In influenza virus infected cells, the interaction of ATR-002 with MEK (MAPK/ERK kinase) prevents export of the viral genome protein complexes (ribonucleoprotein, RNP) from the nucleus to the cytoplasm, thus blocking the formation of functional new viral particles. This ultimately reduces the viral load in the body.[2] In addition, ATR-002 has the potential to modulate the pro-inflammatory cytokine response of the body, avoiding overshooting cytokine response that can be caused by such viral infections. MEK inhibition can reduce the gene expression of some of the cytokines involved, like TNF-α, IL-1ß, IP-10, IL-8, MCP-1 and MIP-1a, and thus mitigate the overactive inflammatory response in the lungs of patients who are severely ill with influenza or COVID-19.[3]

About Atriva Therapeutics GmbH

Atriva Therapeutics, founded in 2015, is a biopharmaceutical company that is pioneering the development of host-targeting antiviral therapies. It was set up by a team of leading scientists in viral research as well as proven industry experts. The company aims to develop a therapy platform to treat severe respiratory diseases induced by RNA viruses with a high unmet medical need, such as influenza and COVID-19. The Atriva lead product ATR-002 is a first-in-class, host-targeting agent that aims to inhibit viral replication in influenza and to favorably modulate the body’s immune response. ATR-002 is under clinical development and has successfully completed a Phase I trial to demonstrate safety and tolerability in healthy subjects. The Company has started a Phase II study to evaluate efficacy in hospitalized COVID-19 patients.1 A Phase II study in influenza is due to start later in 2021. The Company owns 11 patent families with broad international coverage related to the use of MEK inhibitors and other kinase inhibitors for antiviral therapies. The patent life runs through 2041. Atriva Therapeutics is based in Tübingen and Frankfurt, Germany.

Atriva is a founding member of the BEAT-COV initiative. www.beat-cov.de

For further information, please visit www.atriva-therapeutics.com and follow us on LinkedIn and Twitter.

Contact:

Atriva Therapeutics GmbH

Dr. Rainer Lichtenberger, CEO

phone: +49 6196 56 11 698

mobile: +49 151 7443 3175

This email address is being protected from spambots. You need JavaScript enabled to view it.

Media and Investor Relations:

MC Services AG

Eva Bauer / Raimund Gabriel

phone: +49 89 210 228 80

This email address is being protected from spambots. You need JavaScript enabled to view it.

 

[1]     RESPIRE – A Randomized, Double-Blind, Placebo-Controlled, Multi-Centre Clinical Trial to Evaluate the Safety and Efficacy of ATR-002 in Adult Hospitalized Patients with COVID-19.

[2]     Pleschka S et al. Nat Cell Biol 2001 Feb 3:301-5; Planz O Antiviral Res 2013 Jun 98(3):457-68; Haasbach E et al. Antiviral Res 2017 Jun 142:178-4; Laure M et al. Antiviral Res 2020 Jun 178:104806.

[3]     Pinto R et al. Antiviral Res 2011 Oct 92(1):45-56; Planz O Antiviral Res 2013 Jun 98(3):457-68; Schräder T et al. Antiviral Res 2018 Sep 157:80-92.

Atriva Therapeutics kann dank Fördermitteln COVID-19-Medikament schneller entwickeln

  • Bundesministerium für Bildung und Forschung (BMBF) fördert klinische Entwicklung für Therapie von COVID-19 mit bis zu € 11,4 Mio.
  • Produktkandidat ATR-002 könnte Krankenhauspatienten mit COVID-19 vor Beatmung und intensivmedizinischer Behandlung bewahren
  • Therapeutikum, das in der Wirtszelle wirkt und auf RNA-Viren ausgerichtet ist
  • Medikamentenkandidat kann auch bei Corona-Mutationen seine volle Wirkung behalten
  • Therapeutikum hemmt Vermehrung des Virus und verhindert Überschießen der Immunreaktion
  • Einfache Verabreichung als Tablette

Tübingen, 21. April 2021 – Das biopharmazeutische Unternehmen Atriva Therapeutics GmbH, ein Vorreiter bei der Entwicklung von Therapien zur Behandlung von viralen Infektionen, hat sich Fördermittel des Bundes gesichert. Das 2015 gegründete Unternehmen gab heute bekannt, dass es vom Bundesministerium für Bildung und Forschung (BMBF) eine Forschungsförderung erhält. Atriva wird die zugesagten Mittel nutzen, um sein Therapeutikum ATR-002 weiter möglichst schnell zur Marktreife zu entwickeln. „Wir freuen uns über die damit verbundene Anerkennung unserer Arbeit durch das Expertengremium um Prof. Dr. Ciesek und Dr. Spinner“, sagte Atriva-CEO Dr. Rainer Lichtenberger. Die Förderung ist Teil eines BMBF-Programms (Förderung von Forschung und Entwicklung dringend benötigter Therapeutika gegen SARS-CoV-2) im Volumen von € 50 Millionen für insgesamt acht ausgewählte deutsche Unternehmen.

„Die späte klinische Entwicklungsphase und insbesondere Phase III-Zulassungsstudien, sowie die Vorbereitung der Herstellung des Medikaments sind sehr teuer und für kleine Biotech-Unternehmen schwer zu finanzieren“, erklärte Atriva-CEO Dr. Rainer Lichtenberger. „Gerade in dieser weltweiten Notsituation ist eine breite öffentliche Förderinitiative von allergrößter Bedeutung und kann die Entwicklung entscheidend beschleunigen, wie die SARS-CoV-2-Impfstoffe eindrucksvoll gezeigt haben.“

Derzeit wird das Therapeutikum in einer Phase II-Studie namens „RESPIRE“[1] klinisch weiterentwickelt. Es wird nun an COVID-19-Patienten mit moderatem bis schwerem Krankheitsverlauf geprüft, die im Krankenhaus behandelt werden, aber noch keine Beatmung bzw. intensivmedizinische Behandlung benötigen. Die RESPIRE-Studie soll die Wirksamkeit und Sicherheit des Medikamentenkandidaten bei 220 Erwachsenen untersuchen, Mitte April war der erste Patient behandelt worden. Eine Phase I-Studie zur Bewertung der Sicherheit und Verträglichkeit wurde bereits erfolgreich abgeschlossen.

Im Kampf gegen die Pandemie sind nicht nur Impfstoffe gefragt, sondern auch wirksame und sichere Medikamente, um Patienten in verschiedenen Stadien der COVID-19-Erkrankung zu behandeln. „Wir glauben, dass ATR-002 hier großes Potenzial hat, weil es nicht nur die Vermehrung des Virus hemmen, sondern auch das Überschießen der Immunreaktion verhindern kann“, sagte Lichtenberger. „Dadurch werden häufig schwere Krankheitsverläufe hervorgerufen.“ ATR-002 wirkt in der Wirtszelle und wird aufgrund des Wirkmechanismus seine Aktivität auch gegen Virusmutationen wie B.117, B.1.315 und P.1 behalten.

Sollte die derzeit laufende klinische Studie zu guten Ergebnissen und möglicherweise zu einer bedingten Zulassung durch die Behörden führen, kann Atriva das Medikament dank der neuen Fördermittel dem Patienten früher zur Verfügung stellen.

Über die Wirkungsweise von ATR-002

Der Wirkstoffkandidat ATR-002 – das am weitesten fortgeschrittene Produkt von Atriva – befindet sich in klinischer Entwicklung und wurde spezifisch für die Behandlung von Infektions­krankheiten der Atemwege entwickelt, die durch RNA-Viren verursacht werden, wie z.B. Influenza oder COVID-19. ATR-002 ist ein MEK-Inhibitor, der gegen den intrazellulären Raf/MEK/ERK-Signalweg gerichtet ist. Dieser Signalweg ist entscheidend für die Replikation vieler RNA-Viren, zu denen Influenzaviren, Hantaviren oder RS-Viren (respiratory syncytial virus) ebenso gehören wie SARS-CoV-2, das COVID-19 verursacht. Bei Influenzavirus-infizierten Zellen unterbindet ATR-002 über die Inhibition von MEK (MAPK/ERK-Kinase) den Export der viralen Genom-Proteinkomplexe (Ribonukleoproteine, RNPs) vom Zellkern ins Zytoplasma und verhindert so die Bildung neuer funktionaler Viruspartikel. Dadurch wird die Viruslast im Körper reduziert.[2] Daneben hat ATR-002 das Potenzial, das Immunsystem zu modulieren und kann eine überschießende Entzündungsreaktion durch Zytokine, wie sie oft bei schweren Verläufen solcher Virusinfektionen auftritt, hemmen. Bei Patienten, die schwer an Influenza oder COVID-19 erkrankt sind, kann ATR-002 die Genexpression einiger der beteiligten Zytokine, wie TNF-α, IL-1ß, IP-10, IL-8, MCP-1 and MIP-1a, verringern und so die überaktive Immunantwort in der Lunge dieser Patienten abmildern.[3]

Über die Atriva Therapeutics GmbH

Atriva Therapeutics ist ein biopharmazeutisches Unternehmen, das die Entwicklung neuer antiviraler Therapien gegen schwere Virusinfektionen der Atemwege, wie COVID-19 und Influenza, zum Ziel hat. Das 2015 gegründete Unternehmen wurde von einem Team führender Virologen und erfahrenen Branchenexperten aufgebaut und forscht in Indikationen mit hohem ungedecktem medizinischem Bedarf. Atriva konzentriert sich auf die Entwicklung einer Therapieplattform für neuartige Wirkstoffe, die darauf abzielen, eine Vermehrung von Viren zu hemmen, indem sie einen zellulären Faktor, der für die Virusreplikation von wesentlicher Bedeutung ist, blockieren und das Immunsystem modulieren. Das Lead-Produkt ATR-002 ist der erste Vertreter dieser neuen Wirkstoffklasse und befindet sich in klinischer Entwicklung; eine Phase I-Studie zur Bewertung der Sicherheit und Verträglichkeit wurde bereits erfolgreich abgeschlossen. Die klinische Phase II-Studie1 zur Wirksamkeit bei COVID-19 läuft derzeit; eine Phase II-Studie bei Influenza ist für Ende 2021 geplant. Atriva besitzt elf Patentfamilien, die umfassenden, internationalen Patentschutz zur Verwendung von MEK-Inhibitoren und anderen Kinase-Inhibitoren für antivirale Therapien gewähren und bis 2041 gelten. Atriva Therapeutics GmbH ist in Tübingen und Frankfurt am Main ansässig.

Atriva ist Gründungsmitglied der Initiative BEAT-COV www.beat-cov.de.

Für weitere Informationen besuchen Sie bitte www.atriva-therapeutics.com und folgen Sie uns bei LinkedIn und Twitter.

Kontakt:

Atriva Therapeutics GmbH

Dr. Rainer Lichtenberger, CEO

Tel.: +49 6196 56 11 698
Mobil: +49 151 7443 3175

This email address is being protected from spambots. You need JavaScript enabled to view it.

Medien und Investor Relations:

MC Services AG

Eva Bauer

Tel.: +49 (0)89 21022880

This email address is being protected from spambots. You need JavaScript enabled to view it.

 

[1]     RESPIRE – A Randomized, Double-Blind, Placebo-Controlled, Multi-Centre Clinical Trial to Evaluate the Safety and Efficacy of ATR-002 in Adult Hospitalized Patients with COVID-19.

[2]     Pleschka S et al. Nat Cell Biol 2001 Feb 3:301-5; Planz O Antiviral Res 2013 Jun 98(3):457-68; Haasbach E et al. Antiviral Res 2017 Jun 142:178-4; Laure M et al. Antiviral Res 2020 Jun 178:104806.

[3]     Pinto R et al. Antiviral Res 2011 Oct 92(1):45-56; Planz O Antiviral Res 2013 Jun 98(3):457-68; Schräder T et al. Antiviral Res 2018 Sep 157:80-92.

Atriva Therapeutics Announces Changes to Management in COVID-19

  • Olaf Althaus appointed Chief Financial Officer
  • Stephan Stenglein, M.D., recently joined as Chief Medical Officer
  • Proven track record and 20+ years of experience in their respective fields of expertise

Tübingen (Germany), April 13 2021 – Atriva Therapeutics GmbH, a biopharmaceutical company that is pioneering the development of host-targeting antiviral therapies, today announced two changes to its management team. Olaf Althaus was appointed Chief Financial Officer, effective May 2020, while Stephan Stenglein, M.D., was named Chief Medical Officer, effective February 2021.

“We are very pleased to have gained two outstanding specialists to complete our management team – each appointee has vast experience in their respective fields of expertise. Both have worked in the biotech and pharmaceutical industries for the past 20 years at least,” said Dr. Rainer Lichtenberger, CEO of Atriva Therapeutics.

The timing is perfect for Atriva as it is aiming to define and expand the management team’s specific areas of responsibility: “Olaf and Stephan have joined us at an important time as we are currently entering a critical stage in the clinical testing of our lead candidate, ATR-002,” noted Dr. Lichtenberger.

“Besides this, we are honing our financial and organizational strategy to ensure the successful development of ATR-002. Olaf brings a wealth of financial acumen and leadership experience to Atriva. Stephan brings years of expertise in the late-stage clinical development of respiratory drugs. He will play a crucial role in managing our clinical Phase II trial which is key to Atriva’s valuation and success. We warmly welcome Olaf and Stephan to the team,” added Dr. Lichtenberger.

Olaf Althaus is an experienced biotech entrepreneur and manager with a proven track record of more than 20 years in the life science industry. He was co-founder, CEO and CFO at CellMed AG for 12 years and Managing Director at AEterna Zentaris GmbH. Before entering the pharmaceutical industry, he worked in private equity and investment banking for several financial institutes in Frankfurt and London. Olaf holds a degree in industrial engineering, business administration and applied mathematics from Karlsruhe University (Diplom Wirtschaftsingenieurwesen).

Stephan Stenglein, M.D., is a physician trained in clinical and molecular virology with more than 20 years’ experience in the pharmaceutical industry, including in medical device and vaccine development. Stephan was previously VP & Head Late-Stage Development Respiratory at AstraZeneca from March 2018. Prior to that his posts included Global Program Clinical Head and Global Program Medical Director, both in the respiratory field, at Novartis AG; VP Clinical Sciences at Glenmark Pharmaceuticals and Global Medical Director at Shire Plc. Stephan holds an M.D. from the Faculty of Medicine at Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU).

Atriva Therapeutics has recently started a clinical Phase II trial of their lead candidate ATR‑002 in the treatment of moderate to severe COVID-19 in hospitalized patients. RESPIRE[1] – led by Prof. Gernot Rohde, M.D., Head of Pneumology and Professor for Respiratory Medicine and Allergology at the Goethe University Hospital, Frankfurt am Main, Germany – is a randomized, double-blind, placebo-controlled study currently being conducted at national and international study centers, including the Berlin-based Charité. ATR-002 is a small molecule developed against respiratory infection caused by RNA viruses.

About ATR-002’s mode of action with dual benefit

Atriva’s lead product ATR-002 is being developed specifically to treat diseases such as influenza and COVID-19, caused by RNA viruses. ATR-002 is a clinical stage MEK inhibitor drug candidate targeting the intracellular Raf/MEK/ERK-signaling pathway. This pathway is central for replication of many RNA viruses, including the influenza virus, hantavirus or respiratory syncytial virus (RSV) and also SARS-CoV-2, the virus that causes COVID-19. In influenza virus-infected cells, the interaction of ATR-002 with MEK (MAPK/ERK kinase) prevents the export of the viral genome protein complexes (ribonucleoprotein, RNP) from the nucleus to the cytoplasm, thus blocking the formation of functional new viral particles. This ultimately reduces the viral load in the body.[2] In addition, ATR-002 has the potential to modulate the pro-inflammatory cytokine response of the body, avoiding an overshooting cytokine response that can be caused by such viral infections. MEK inhibition can reduce the gene expression of some of the cytokines involved, such as TNF-α, IL-1ß, IP-10, IL-8, MCP-1 and MIP-1a, and thus mitigate the overactive inflammatory response in the lungs of patients who are severely ill with influenza or COVID-19.[3]

About Atriva Therapeutics GmbH

Atriva Therapeutics, founded in 2015, is a biopharmaceutical company that is pioneering the development of host-targeting antiviral therapies. It was set up by a team of leading scientists in viral research as well as proven industry experts. The company aims to develop a therapy platform to treat severe respiratory diseases induced by RNA viruses with a high unmet medical need, such as influenza and COVID-19. The Atriva lead product ATR-002 is a first-in-class, host-targeting agent that aims to inhibit viral replication in influenza and to favorably modulate the body’s immune response. ATR-002 is under clinical development and has successfully completed a Phase I trial to demonstrate safety and tolerability in healthy subjects. The Company has started a Phase II study to evaluate efficacy in hospitalized COVID-19 patients.[1] A Phase II study in influenza is due to start later in 2021. The Company owns 11 patent families with broad international coverage related to the use of MEK inhibitors and other kinase inhibitors for antiviral therapies. The patent life runs through 2041. Atriva Therapeutics is based in Tübingen and Frankfurt, Germany.

Atriva is a founding member of the BEAT-COV initiative. www.beat-cov.de

For further information, please visit www.atriva-therapeutics.com and follow us on LinkedIn and Twitter.

Contact:
Atriva Therapeutics GmbH

Dr. Rainer Lichtenberger, CEO
phone: +49 6196 56 11 698
mobile: +49 151 7443 3175
This email address is being protected from spambots. You need JavaScript enabled to view it.

Media and Investor Relations:
MC Services AG

Eva Bauer / Raimund Gabriel
phone: +49 89 210 228 80
This email address is being protected from spambots. You need JavaScript enabled to view it.

[1]     RESPIRE – A Randomized, Double-Blind, Placebo-Controlled, Multi-Centre Clinical Trial to Evaluate the Safety and Efficacy of ATR-002 in Adult Hospitalized Patients with COVID-19.
[2]     Pleschka S et al. Nat Cell Biol 2001 Feb 3:301-5; Planz O Antiviral Res 2013 Jun 98(3):457-68; Haasbach E et al. Antiviral Res 2017 Jun 142:178-4; Laure M et al. Antiviral Res 2020 Jun 178:104806.
[3]     Pinto R et al. Antiviral Res 2011 Oct 92(1):45-56; Planz O Antiviral Res 2013 Jun 98(3):457-68; Schräder T et al. Antiviral Res 2018 Sep 157:80-92.

Atriva Therapeutics Doses First Patient in Phase II RESPIRE trial in COVID-19

  • Charité – Universitätsmedizin Berlin, Germany, enrolls first patient in Phase II study to assess oral treatment ATR-002
  • RESPIRE[1] is a placebo-controlled, international, multi-center trial in hospitalized patients with moderate to severe COVID-19

Tübingen (Germany), April 13, 2021 – Atriva Therapeutics GmbH, a biopharmaceutical company that is pioneering the development of host-targeting antiviral therapies, announced today that the first patient was enrolled in its Phase II RESPIRE1 trial in COVID-19. Prof. Martin Witzenrath, M.D., Vice Director Department of Infectious Diseases and Respiratory Medicine, supervised the first administration of study medication (MEK inhibitor ATR-002 or placebo) at the Charité – Universitätsmedizin Berlin, Germany.

“We are excited to assess the efficacy of ATR-002 in treating COVID-19 and are looking forward to the results of the clinical trial. We can now test our lead candidate against SARS‑CoV‑2 because our pharmacological target is a common cellular mechanism that RNA viruses use. ATR‑002 leaves the virus itself untouched but blocks a cellular factor that the virus needs for its replication and has the potential to reduce the viral load in the infected host,” said Dr. Rainer Lichtenberger, CEO of Atriva Therapeutics. “Host-directed approaches maintain efficacy also against mutated viruses – a problem that we are commonly seeing in the influenza virus and, unfortunately, in SARS-CoV-2 as well. If we were to see the positive outcomes of the trial we hope for, ATR-002 could provide efficient help against COVID-19 regardless of the given genetic subtype of the underlying viral strain.”

“While we have been lucky that SARS-CoV-2 vaccines were developed at unprecedented speed, we still are in desperate need for effective therapies against COVID-19. The pandemic situation remains very critical and is far from being under control,” added Global Coordinating Investigator of the RESPIRE trial Prof. Gernot Rohde, M.D., Head of Pneumology and Professor for Respiratory Medicine and Allergology at the Goethe University Hospital, Frankfurt am Main, Germany. “Being able to contribute to the development of a COVID-19 therapy, I am very much looking forward to the effects that we may see with ATR-002. I am convinced that a medication that can prevent hospitalized patients with a moderate to severe stage of COVID-19 from deteriorating and requiring ICU admission and ventilator support would mean a huge progress and could also play a role in impeding the severe long-term effects that are being described as “Long COVID” Syndrome (PASC).”

RESPIRE1 is a randomized, double-blind, placebo-controlled, international, multi-center Phase II clinical trial in 220 adult patients with moderate to severe COVID-19, requiring hospitalization, but not requiring ICU admission or ventilator support at the time of screening or randomization. On top of standard of care, half of the patients will receive ATR-002 900 mg, administered as tablets once daily on day 1, followed by ATR-002 600 mg once daily on days 2 to 6. Patients in the control group will receive placebo in a matching scheme, on top of standard of care.

Primary objective of the study is to demonstrate the efficacy of ATR-002 versus placebo in addition to standard of care; secondary endpoints include the measurement of changes in clinical signs and symptoms as well as other relevant clinical parameters. Outcomes will be assessed based on the clinical severity status on day 15, using a 7-point ordinal scale as suggested by the WHO COVID-19 Therapeutic Trial Synopsis.[2] All patients will be followed-up for 90 days. The study will also evaluate the pharmacokinetics of ATR-002.

About ATR-002’s mode of action with dual benefit

Atriva’s lead product ATR-002 is developed specifically to treat diseases such as influenza and COVID-19, caused by RNA viruses. ATR-002 is a clinical stage MEK inhibitor drug candidate targeting the intracellular Raf/MEK/ERK signaling pathway. This pathway is central for replication of many RNA viruses, such as the influenza virus, hantavirus or respiratory syncytial virus (RSV) and also SARS-CoV-2, the virus that causes COVID-19. In influenza virus infected cells, the interaction of ATR-002 with MEK (MAPK/ERK kinase) prevents export of the viral genome protein complexes (ribonucleoprotein, RNP) from the nucleus to the cytoplasm, thus blocking the formation of functional new viral particles. This ultimately reduces the viral load in the body.[3] In addition, ATR-002 has the potential to modulate the pro-inflammatory cytokine response of the body, avoiding overshooting cytokine response that can be caused by such viral infections. MEK inhibition can reduce the gene expression of some of the cytokines involved, like TNF-α, IL-1ß, IP-10, IL-8, MCP-1 and MIP-1a, and thus mitigate the overactive inflammatory response in the lungs of patients who are severely ill with influenza or COVID-19.[4]

About Atriva Therapeutics GmbH

Atriva Therapeutics, founded in 2015, is a biopharmaceutical company that is pioneering the development of host-targeting antiviral therapies. It was set up by a team of leading scientists in viral research as well as proven industry experts. The company aims to develop a therapy platform to treat severe respiratory diseases induced by RNA viruses with a high unmet medical need, such as influenza and COVID-19. The Atriva lead product ATR-002 is a first-in-class, host-targeting agent that aims to inhibit viral replication in influenza and to favorably modulate the body’s immune response. ATR-002 is under clinical development and has successfully completed a Phase I trial to demonstrate safety and tolerability in healthy subjects. The Company has started a Phase II study to evaluate efficacy in hospitalized COVID-19 patients.1 A Phase II study in influenza is due to start later in 2021. The Company owns 11 patent families with broad international coverage related to the use of MEK inhibitors and other kinase inhibitors for antiviral therapies. The patent life runs through 2041. Atriva Therapeutics is based in Tübingen and Frankfurt, Germany.

Atriva is a founding member of the BEAT-COV initiative. www.beat-cov.de

For further information, please visit www.atriva-therapeutics.com and follow us on LinkedIn and Twitter.

Contact:
Atriva Therapeutics GmbH

Dr. Rainer Lichtenberger, CEO
phone: +49 6196 56 11 698
mobile: +49 151 7443 3175
This email address is being protected from spambots. You need JavaScript enabled to view it.

Media and Investor Relations:
MC Services AG

Eva Bauer / Raimund Gabriel
phone: +49 89 210 228 80
This email address is being protected from spambots. You need JavaScript enabled to view it.

[1]     RESPIRE – A Randomized, Double-Blind, Placebo-Controlled, Multi-Centre Clinical Trial to Evaluate the Safety and Efficacy of ATR-002 in Adult Hospitalized Patients with COVID-19.
[2]     https://www.who.int/publications/i/item/covid-19-therapeutic-trial-synopsis.
[3]     Pleschka S et al. Nat Cell Biol 2001 Feb 3:301-5; Planz O Antiviral Res 2013 Jun 98(3):457-68; Haasbach E et al. Antiviral Res 2017 Jun 142:178-4; Laure M et al. Antiviral Res 2020 Jun 178:104806.
[4]     Pinto R et al. Antiviral Res 2011 Oct 92(1):45-56; Planz O Antiviral Res 2013 Jun 98(3):457-68; Schräder T et al. Antiviral Res 2018 Sep 157:80-92.

Atriva Therapeutics Announces Changes to Advisory Board

  • Serial German biotech entrepreneur Dr. Ulrich Dauer appointed as new Chairman
  • Michael Grissinger to replace Emilie Hofstetter, adding pharmaceutical deal-making and US market expertise
  • Atriva Therapeutics is currently investigating its lead candidate ATR-002 in a Phase II trial against COVID-19

Tübingen and Frankfurt (Germany), January 20, 2021 – Atriva Therapeutics GmbH, a biopharmaceutical company pioneering the development of host-targeting antiviral therapies, today announced changes to its Advisory Board. The Company appointed Dr. Ulrich Dauer as new Chairman of the Advisory Board succeeding co-founder Prof. Dr. Stephan Ludwig who will continue to serve on the Advisory Board of Atriva Therapeutics. Effective end of 2020, Emilie Hofstetter resigned from the Board. Michael Grissinger took over her position by Jan 1st, 2021.

“We would like to warmly thank Prof. Stephan Ludwig and Emilie Hofstetter for their strong commitment over the last years since the foundation of the Company and their advice in advancing Atriva’s scientific and corporate achievements to clinical trials. Prof. Ludwig will continue to offer his scientific insight and expertise as virologist in the Advisory Board, which are highly valuable for our future development,” said Dr. Rainer Lichtenberger, CEO of Atriva Therapeutics, continuing: “With Dr. Ulrich Dauer and Michael Grissinger we were able to attract two accomplished sector specialists to our Advisory Board. Both have several decades of experience in the biotech and pharmaceutical industry. Their proven expertise in effectively managing biotech and pharmaceutical companies, leading transactions and forming strong collaborations will be invaluable as Atriva advances in clinical development, diversifying its later-stage clinical pipeline.”

Dr. Ulrich Dauer is a biotechnology entrepreneur and serial executive with long term experience and has been serving as Chief Executive Officer of Vivoryon Therapeutics N.V. since May 2018. Before that, he was CEO of Ventaleon GmbH and OMEICOS Therapeutics GmbH, founding CEO of 4SC AG, and Chief Strategy Officer at Activaero GmbH. His expertise focuses on successfully leading critical advances of biotech companies, including IPOs, financial and business transactions, partnerships and assembling clinical pipelines. Dr. Dauer received his PhD in natural sciences from Julius-Maximilians Universitaet Wuerzburg, Germany.

“I am excited to support Atriva, “said Dr. Ulrich Dauer, Chair of Atriva’s Advisory Board. “I have a special interest in the field of respiratory infections, particularly influenza, and am impressed by this new and innovative approach to antiviral treatment that Atriva is developing. If proven successful also in the later clinical phases, Atriva’s approach of stopping virus propagation by inhibiting necessary host cell factors could become the first true broad-band antiviral.”

Michael Grissinger is a senior executive with a proven track-record in key leadership roles in the pharmaceutical industry with a focus on pharmaceutical deal-making, strategy, and business development. Currently, he is serving on the Boards of Directors of several private and publicly traded biotech and pharmaceutical companies and advising a private equity firm. Before, he was at Johnson & Johnson for over 20 years, where he held several corporate vice-presidential roles focusing on global business development and licensing. His earlier career included positions at Ciba-Geigy, SmithKline Beckman, and Upjohn. He holds a Bachelor of Science (B.S.) in Chemistry from Juniata College, Huntingdon, Pennsylvania, USA, and a Master of Business Administration (M.B.A.) from Temple University – Fox School of Business in Philadelphia, USA.

“Atriva Therapeutics is at a critical development stage, advancing its clinical candidate into Phase II against COVID-19, the pandemic that is still keeping the world breathless,” said Michael Grissinger. “Looking ahead, securing pandemic preparedness will be crucial for humankind, and Atriva Therapeutics could play a central role in it. I am therefore more than happy to support the growth and future company development with my experience and to become part of this exciting story.”

Atriva’s Advisory Board consists of five members and two observers. In addition to Dr. Ulrich Dauer, Michael Grissinger and Prof. Stephan Ludwig there are two members who will continue to represent Atriva’s largest investors on the Board: Frans van Dalen and Paul Lelieveld represent the investor Meneldor. The two observers Frank Hensel, PhD, represent the Hightech-Gründer-Fonds Management GmbH and Rudolf Erlemann, PhD, sits for InSymbiosis.

Atriva Therapeutics has recently started a clinical Phase II trial investigating their lead candidate ATR-002 against moderate to severe COVID-19 in hospitalized patients. RESPIRE is a randomized, double-blind, Placebo-controlled study, which will be conducted at national and international study centers including Berlin-based Charité. ATR-002 is a small molecule developed against respiratory infection of RNA viruses.

About ATR-002’s mode of action with dual benefit

The Atriva lead product ATR-002 is developed specifically to treat diseases such as influenza and COVID-19, caused by RNA viruses. ATR-002 is a clinical stage MEK inhibitor drug candidate targeting the intracellular Raf/MEK/ERK signaling pathway. This pathway is central for replication of many RNA viruses, such as the influenza virus, hantavirus or respiratory syncytial virus (RSV) and also SARS-CoV-2, the virus that causes COVID-19. In influenza virus infected cells, the interaction of ATR-002 with MEK (MAPK/ERK kinase) prevents export of the viral genome protein complexes (ribonucleoprotein, RNP) from the nucleus to the cytoplasm, thus blocking the formation of functional new viral particles. This ultimately reduces the viral load in the body.[i]

In addition, ATR-002 has the potential to modulate the pro-inflammatory cytokine response of the body, avoiding overshooting cytokine response that can be caused by such viral infections. MEK inhibition can reduce the gene expression of some of the cytokines involved, like TNF-α, IL-1ß, IP-10, IL-8, MCP-1 and MIP-1a, and thus mitigate the overactive inflammatory response in the lungs of patients who are severely ill with influenza or COVID-19.[ii]

About Atriva Therapeutics GmbH

Atriva Therapeutics, founded in 2015, is a biopharmaceutical company pioneering the development of host-targeting antiviral therapies set up by a team of leading scientists in viral research and seasoned industry experts. The Company aims to develop a therapy platform to treat severe respiratory diseases induced by RNA viruses with a high unmet medical need, such as influenza and COVID-19. The Atriva lead product ATR-002 is a first-in-class host-targeting agent which inhibits viral replication in influenza and favorably modulates the body’s immune response. ATR-002 is under clinical development and has successfully completed a Phase I trial to demonstrate safety and tolerability in healthy subjects. The Company has obtained regulatory approval for a Phase II study to evaluate efficacy in hospitalized COVID-19 patients; a Phase II study in influenza is planned to start later in 2021. The Company owns eleven patent families with broad international coverage related to the use of MEK inhibitors and other kinase inhibitors for antiviral therapies. The patent life runs through 2041. Atriva Therapeutics is located in Tübingen and Frankfurt, Germany.

Atriva is a founding member of the BEAT-COV initiative. www.beat-cov.de

For further information, please visit www.atriva-therapeutics.com and follow us on LinkedIn and Twitter.

Contact:

Atriva Therapeutics GmbH
Dr. Rainer Lichtenberger, CEO
phone: +49 6196 56 11 698
mobile: +49 151 7443 3175
This email address is being protected from spambots. You need JavaScript enabled to view it.

Media and Investor Relations:

MC Services AG
Eva Bauer / Raimund Gabriel
phone: +49 89 210 228 80
This email address is being protected from spambots. You need JavaScript enabled to view it.

 [i]     Pleschka S et al. Nat Cell Biol 2001 Feb 3:301-5; Planz O Antiviral Res 2013 Jun 98(3):457-68; Haasbach E et al. Antiviral Res 2017 Jun 142:178-4; Laure M et al. Antiviral Res 2020 Jun 178:104806.
[ii]     Pinto R et al. Antiviral Res 2011 Oct 92(1):45-56; Planz O Antiviral Res 2013 Jun 98(3):457-68; Schräder T et al. Antiviral Res 2018 Sep 157:80-92.

Address

Atriva Therapeutics GmbH
Eisenbahnstr. 1, 72072 Tübingen

+49 (0)7071 8597673
info@atriva-therapeutics.com

LinkedIn
Twitter

In order to be able to design our website in the best possible way and to continuously improve it, we are using cookies. By continuing to use our website, you permit the use of cookies. More information can be found in our data protection rules.