· Atriva Therapeutics announces publication of results from the Phase 2a RESPIRE study in eClinicalMedicine (part of THE LANCET Discovery Science)
· Results reflect clinically relevant efficacy for zapnometinib, in terms of the primary endpoint - clinical severity status (CSS) at Day 15 with zapnometinib`s safety profile comparable to placebo
· Trial results provide solid foundation for further clinical development of zapnometinib in severe Influenza
Atriva Therapeutics GmbH, a biopharmaceutical company pioneering the development of host-targeting antiviral therapies, announced today the publication of proof-of-concept data for its oral MEK inhibitor, zapnometinib, in hospitalized patients with moderate-to-severe COVID-19 in the journal eClinicalMedicine.
The double-blind, placebo-controlled RESPIRE trial investigated the safety and efficacy of zapnometinib in hospitalized adults with COVID-19 at 17 sites worldwide. The trial was terminated early as the emergence of the Omicron variant impacted recruitment. Despite the early termination, patients on zapnometinib had higher odds of improved clinical status score (CSS) vs placebo (odds ratio [OR] 1·54 [95% CI 0·72–3·33]; p=0·262). The frequency and intensity of adverse events were low and similar between the zapnometinib and placebo arms. Further details on the study and trial results can be found at: https://www.thelancet.com/journals/eclinm/article/PIIS2589-5370(23)00414-5/fulltext
"These results provide proof-of-concept for the innovative approach of targeting the Raf/MEK/ERK pathway in hospitalized patients with moderate or severe COVID-19," said Dr. Stephan Stenglein, Chief Medical Officer of Atriva Therapeutics.
Zapnometinib is an oral, non-ATP-competitive, small-molecule inhibitor of MEK1/MEK2 with immunomodulatory and antiviral properties. Atriva is continuing the development of zapnometinib in severe viral diseases with epidemic or pandemic potential, aiming to confirm the promising results from the RESPIRE study.
Christian Pangratz, CEO of Atriva Therapeutics, concludes: “The encouraging study results from the RESPIRE trial establish a strong foundation for us to advance zapnometinib into the next clinical study in which we plan to demonstrate the molecule’ s efficacy and safety in patients hospitalized with severe seasonal influenza.”
The RESPIRE trial was funded by Atriva Therapeutics GmbH, the German Federal Ministry of Education and Research and co-funded by the European Investment Bank.
About the RESPIRE study
RESPIRE (1) was a randomized, double-blind, placebo-controlled, international, multi-center POC (Proof of Concept) / Phase 2 clinical trial in adult patients with moderate-to-severe COVID-19. Hospitalized patients with or without supplemental oxygen at the time of screening or randomization were enrolled. On top of standard of care, patients were randomized to receive zapnometinib (ATR-002) 900 mg tablets, once daily on Day 1, followed by zapnometinib 600 mg once daily on Days 2 to 6, or to receive placebo in a matching scheme.
The study was designed to establish the efficacy of zapnometinib; the primary endpoint was CSS on Day 15, using a seven-point ordinal scale as recommended by the WHO COVID-19 Therapeutic Trial Synopsis.(2) Secondary endpoints included time to hospital discharge, changes in clinical signs and symptoms and other relevant clinical parameters. All patients were followed-up for 90 days.
About zapnometinib
The Atriva lead product zapnometinib (ATR-002) was specifically developed to treat diseases caused by RNA viruses, such as influenza and COVID-19. Zapnometinib is a MEK inhibitor targeting the intracellular Raf/MEK/ERK signaling pathway. Many RNA viruses need to activate this pathway to ensure replication, including influenza viruses (3,4), hanta viruses (4), the respiratory syncytial virus (RSV) (4), and coron...
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