French biotech firm Biophytis will assess its Sarconeos (BIO101) drug as a treatment for respiratory failure caused by Covid-19 after partnering with contract research organisation (CRO) SGS.
SGS has secured regulatory approval from Belgium’s Federal Agency for Medicines and Health Products (FAMHP) to conduct a COVA clinical trial of the investigational therapy.
SARS-CoV-2, the coronavirus that causes Covid-19, is known to develop acute respiratory distress syndrome (ARDS) by disrupting the renin angiotensin system (RAS), which is involved in respiratory function regulation.
The COVA study will investigate the ability of Sarconeos to block ARDS development via the activation of the mitochondrial assembly (Mas) receptor, a key component of the renin-angiotensin system (RAS)’s protective arm.
SGS will perform the trial at several sites globally, starting at the AZ Sint Maarten hospital in Mechelen, Belgium.
SGS Global Clinical Operations director Steven Thys said: “We have been working intensively with our partners at AZ Sint-Maarten and Biophytis to get this COVA study started as quickly as possible.
“The positive and fast approval given by FAMHP is the result of excellent teamwork and demonstrates our commitment to supporting biotech companies such as Biophytis as it advances its research into new therapies against Covid-19.”
During the first stage of the two-part study, 50 patients who have developed severe respiratory symptoms in the last seven days will be enrolled. The study will not recruit patients requiring high-flow oxygen use or assisted ventilation in the previous 28 days.
The trial will assess the safety and tolerability of Sarconeos, and also improvements in respiratory function and the impact on biomarkers of inflammation and the RAS.
An independent data monitoring committee (IDMC) will perform interim analysis after this initial 28-day trial to obtain preliminary results on the efficacy of the drug to prevent the deterioration of respiratory function.
The interim analysis will also establish if the trial should progress into stage two, which will enrol at least 540 patients.