Atriva Therapeutics announces publication of Proof of Concept (POC) / Phase 2a RESPIRE study data with zapnometinib in patients hospitalized with COVID-19
04.10.2023
• 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
Tübingen/Martinsried, Germany, 04 October 2023
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.
Zapnometinib is under advanced clinical development as a treatment for patients with severe influenza or COVID-19. For the treatment of hantavirus infections, zapnometinib has been granted Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration (FDA).
Komplette Pressemitteilung abrufen:
https://www.atriva-therapeutics.com/wp-content/uploads/2023/10/2023-10-04-RESPIRE-Study-Publication.pdf
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