Biotechnology firm Biophytis has started enrolment and dosing of patients in a Phase II/III clinical trial to assess Sarconeos (BIO101) for treating respiratory failure due to Covid-19.
The first participant was dosed at AZ Sint Maarten hospital in Mechelen, Belgium.
Named COVA, the trial currently has five centres active for enrolment in Belgium, France and the US. It will also be performed in Brazil and the UK.
The multi-national, randomised, double-blind, placebo-controlled, adaptive and group sequential Phase II/III trial will investigate the safety and efficacy of Sarconeos in preventing further respiratory deterioration in patients with severe respiratory failure.
During the first portion of the two-part study, the drug candidate will be evaluated for its treatment safety and anti-viral activity in 50 hospitalised Covid-19 patients with acute respiratory deficiency.
The second portion will assess Sarconeos’ efficacy on the respiratory function in an additional 260 patients. The trial aims to enrol a total of approximately 310 patients.
Primary endpoint of the trial is the proportion of all-cause mortality and respiratory deterioration within up to a 28-day period.
Secondary endpoints include improvement, worsening and hospital discharge, functional scales and the biomarkers of Sarconeos mechanism of action and inflammation.
Biophytis CEO Stanislas Veillet said: “Whilst in many countries Covid-19 has continued its steady spread, in Europe we are seeing again a worrying increase of new Covid-19 cases.
“With physicians still in need of effective treatments for Covid-19-related respiratory failure, we believe Sarconeos (BIO101) has the potential to serve as a differentiated treatment option for patients with severe respiratory manifestations.”
In July this year, Biophytis partnered with contract research organisation (CRO) SGS to study Sarconeos as a treatment for Covid-19-related respiratory failure.
SGS secured regulatory approval from Belgium’s Federal Agency for Medicines and Health Products (FAMHP) to conduct the COVA study.