Biophytis will begin recruiting patients in France and Belgium for the second part of the COVA Study analyzing its leading drug candidate as a potential treatment for acute respiratory failure linked to COVID-19.
Biophytis has announced that it will begin recruiting patients in France and Belgium for the second part of the COVA Study analyzing Sarconeos (BIO101), its leading drug candidate, as a potential treatment for acute respiratory failure linked to COVID-19.
Along with Regulatory Authorities in Brazil and the U.S. providing authorization for the start of part 2 clinical trials, authorization has also been obtained in France and Belgium to begin recruitment, according to a company news release.
This follows the completion of enrollment for part 1 of the study, which includes 50 participants.
The COVA Study is a global, multi-center, double-blind, placebo-controlled, two-part phase 2-3 study assessing Sarconeos (BIO101), administered orally, in patients aged 45 and older who have been hospitalized with severe respiratory manifestations of COVID-19, the release stated.
The first part of the study targets preliminary data on the safety, tolerability and activity of Sarconeos (BIO101) in the trial’s participants. Interim analysis is tentatively expected later in this first quarter of this year, pending COVID-19 related delays or pandemic impacts, according to the company.
The second part of the COVA Study includes a phase 3 pivotal randomized study investigating the safety, efficacy of Sarconeos (BIO101) in the respiratory function of 310 COVID-19 patients (including the 50 patients from part 1 of the study), the company states.
Complete results from both part 1 and part 2 of the study are expected in the second quarter of this year, pending any COVID-19-related delays, patient enrollment issues, or other interruptions.