A proof of concept (POC) study has shown the clinical benefit of zapnometinib in patients with severe Covid-19 and supports further evaluation in severe viral diseases.
Atriva Therapeutics and investigators will continue to evaluate the RESPIRE data and will provide an update on the full dataset in due course.
The POC / Phase IIa RESPIRE study (zapnometinib) in patients hospitalised with moderate-to-severe Covid-19 met its primary endpoint of improvement on the clinical severity status (CSS) scale.
It was hoped that RESPIRE would include 220 patients, however, due to the lower frequency of Covid-19 hospitalisations caused by the Omicron variant compared with previous variants, just 104 patients were included.
Of these patients, 40% required supplemental oxygen in the zapnometinib arm and 41% required supplemental oxygen in the placebo arm.
Results from both the primary (improvement on the World Health Organization CSS scale) and key secondary (time to hospital discharge) endpoints in RESPIRE indicate a clear benefit amongst patients with more severe disease activity (CSS 4).
Patients infected with the Delta variant of SARS-CoV-2 had significantly better outcomes compared to those infected with the Omicron variant.
Prof Gernot Rohde, MD, Head of Pneumology and Professor for Respiratory Medicine and Allergology at the Goethe University Hospital, Frankfurt am Main, Germany, Investigator RESPIRE) commented: “Despite recent approvals of treatments for patients with severe Covid-19, there remains a significant unmet medical need for targeted, effective therapies in severe viral respiratory infections.
“The data for zapnometinib from the RESPIRE Study are highly encouraging and suggest that the innovative approach of targeting the intracellular Raf/MEK/ERK signaling pathway may prove to be effective in treating such conditions.”