Atriva Therapeutics Reports Results of ATR-002 Phase I Clinical Trial

• ATR-002 proved to be safe and well tolerable in 70 healthy volunteers
• A clinical Phase II safety and efficacy trial is planned for 2020 for the treatment of influenza, an indication with a very high unmet medical need

Tübingen (Germany), November 08, 2019 – Atriva Therapeutics GmbH, a biopharma­ceutical company pioneering the development of host-targeting antiviral therapies, today announced the successful conclusion and top-line results of its Phase I clinical trial for its lead drug candidate ATR-002. The official report will be released in January 2020.

Only few adverse events in total and no serious adverse events were observed during the trial. ATR-002 is thus considered to be safe and well tolerable. Pharmacokinetics exposure and determination of MEK inhibition were verified and confirm the maintenance of clinically relevant blood levels.

The randomized, double blind, placebo-controlled dose escalation study (EudraCT 2019-000784-25), conducted in Belgium, demonstrated the safety and tolerability of ATR-002 in 70 healthy volunteers. It followed an adaptive design with a starting dose of 100 mg and up to three escalation steps in seven arms, following a single ascending dose / multiple ascending dose (SAD / MAD) regime. Administration scheme was one dose ATR-002, escalating 100 mg to 900 mg (SAD), followed by seven doses ATR-002, escalating 100 mg to 600 mg QD over seven days (MAD). Each dose cohort was considered to be safe by the Safety Review Committee (SRC), with release allowed for the next higher dose (up to SAD 900 mg and MAD 600 mg, respectively). The observed pharmacokinetic profile supports the intended once-daily regime for the further Phase II clinical development.

“We are proud to successfully conclude the clinical Phase I with ATR-002, our first-in-class MEK inhibitor for the treatment of influenza virus infections,” commented Dr. Rainer Lichtenberger, co-founder and CEO of Atriva. “Confirming safety and tolerability plus establishing a pharmacokinetic profile suitable for a once-daily regime is a first important clinical milestone in the development of an innovative influenza drug that could represent the next level in treating this serious public health danger along with its ever-looming threat of a new pandemic.” Several international organizations recently warned that worldwide, prevention will not be sufficient to impede a new influenza pandemic, among those the Global Preparedness Monitoring Board established by World Health Organization and World Bank in “A World at Risk – Annual Report on global preparedness for health emergencies” [1], and the Nuclear Threat Initiative (NTI) in cooperation with the internationally renowned Johns Hopkins Bloomberg School of Public Health in their Global Health Security Index 2019 [2].

ATR-002 is a first-in-class MEK inhibitor of viral replication, targeting a fundamental host-cellular protein in the replication pathway of influenza-causing viruses. MEK inhibitors have shown high potential as efficacious antiviral drugs, which address the need for a novel, broadly active, resistance-avoiding influenza therapy. Potential advantages of this host-targeting approach are the prolonged treatment window and the reduced potential of viral resistance, both compared to therapies that directly target viral structures.

About ATR-002’s mode of action

Atriva’s lead product ATR-002 is a clinical stage MEK inhibitor drug candidate targeting the intracellular Raf/MEK/ERK signaling pathway. 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 hindering the formation of functional new viral particles. This ultimately reduces the viral load in the body. Clinical development will be supported by an exploratory biomarker indicating MEK inhibition, via measurement of ERK phosphorylation in the cell.

About Atriva Therapeutics GmbH

Atriva Therapeutics, founded in 2015, is a biopharmaceutical company pioneering the development of host-targeting antiviral therapies setup by a team of leading scientists in viral research and seasoned industry experts. The Company aims to develop new antiviral therapies against different respiratory viral infections. Atriva’s lead product ATR-002 is a first-in-class host-targeting agent, inhibiting viral replication in influenza and other respiratory infections, an area of high unmet medical need. ATR-002 is under clinical development and has successfully completed a Phase I trial to demonstrate safety and tolerability in healthy subjects. The Company owns nine broad patent families with broad coverage related to the use of MEK inhibitors and other kinase inhibitors for anti-viral therapies. The patent life runs through 2039. Atriva Therapeutics is located in Tübingen and Frankfurt, Germany.

For further information, please visit www.atriva-therapeutics.com.

[1]      https://apps.who.int/gpmb/assets/annual_report/GPMB_Annual_Report_Exec_Summary_Foreword_and_About_English.pdf
[2]     https://www.ghsindex.org/wp-content/uploads/2019/10/2019-Global-Health-Security-Index.pdf