Atriva Therapeutics Starts Clinical Development of Novel Host-Targeting Antiviral ATR-002 Against Influenza

• Phase I clinical trial to evaluate safety and tolerability of ATR-002 in healthy volunteers
• ATR-002 expected to show high resilience to viral resistance and prolonged treatment window
• Novel approach to treating influenza, one of the most prominent global health challenges, according to WHO
• Atriva Therapeutics to present at Bio€quity in Barcelona on May 20, 2019

Tübingen (Germany), May 16, 2019 – Atriva Therapeutics GmbH, a biopharmaceutical company pioneering the development of host-targeting antiviral therapies, today announced the first dosing of its lead drug candidate ATR-002 in a Phase I clinical trial (EudraCT 2019-000784-25). The dosing marks the start of the clinical development of this novel host-targeted approach to treating influenza virus infections.

The randomized, double blind dose escalation study, now running in Belgium, will assess the safety and tolerability of ATR-002 in 60 healthy volunteers, randomized into three arms.

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 reduced potential to viral resistance and the prolonged treatment window, both compared to therapies that directly target viral structures.

According to the World Health Organization (WHO), influenza remains a global challenge for public health with an estimated one billion people affected every year, of which three to five million cases are considered severe. In particular, fatalities are high with 290,000 to 650,000 influenza-related respiratory deaths worldwide.^[1] “As of today, there is a high unmet medical need for an efficient, safe influenza therapy to treat acute disease patients,” commented Dr. Rainer Lichtenberger, co-founder and CEO of Atriva. “Novel flu virus strains are emerging every year, and antiviral approaches based on small-molecules are often associated with the development of resistances and a short treatment window.” ^[2]

“The successful filing of a Clinical Trial Application in Europe followed by the start of the first-in-human clinical trial for ATR-002 are significant milestones for our Company. Today’s news brings us to the doorstep of demonstrating clinical proof-of-concept for ATR-002 as a potential first-in-class, once-daily oral influenza therapy,” added Prof. Dr. Oliver Planz, co-founder and CSO of Atriva.

Preclinical data showed that an oral application of ATR-002 leads to the rapid and long-lasting inhibition of the Raf/MEK/ERK pathway and consequently, inhibition of reproduction of virus particles in the body. Compared to standard of care, absence of resistance formation and a longer treatment window were observed. Most currently approved drugs show efficacy only when administered within 48 hours after the onset of acute disease. Often, patients are not eligible for these drugs or do not respond to therapy due to a delayed diagnosis.

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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 in a Phase I trial to evaluate safety and tolerability in healthy subjects. The Company owns seven 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] Global influenza strategy 2019-2030. Geneva: World Health Organization; 2019.
^[2] Guidance for Industry Influenza: Developing Drugs for Treatment and/or Prophylaxis. U.S. Food and Drug Administration, Center for Drug Evaluation and Research (CDER); 2011.