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.
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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.
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By GlobalDataPrimary 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.
