Biophytis is set to initiate patient recruitment at most of the clinical centres in Brazil and the US for Part 2 of its COVA Study of its small molecule oral drug candidate, Sarconeos (BIO101), to treat Covid-19-related acute respiratory failure.
The global, multi-centre, double-blind, placebo-controlled, group-sequential and adaptive design two-part Phase II-III COVA study will evaluate Sarconeos in patients aged 45 years and above hospitalised with severe Covid-19 respiratory manifestations.
The company has concluded enrolment for Part 1 of the COVA Study, with 50 patients recruited in Brazil, the US, Belgium and France.
As the Data Monitoring Committee (DMC) recommended initiating recruitment for Part 2, Biophytis is obtaining authorisation from various regulatory authorities in Brazil and the US for commencing Part 2.
Authorisations are also being pursued in France, Belgium and the UK.
Biophytis CEO Stanislas Veillet said: “We are extremely pleased to start recruiting patients for Part 2 at most clinical centres in Brazil and the US.
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“There continues to be an unmet need for new Covid-19 treatment options for elderly patients, or patients with co-morbidities, who will continue to be at high risk of developing severe respiratory manifestations requiring hospitalisation.”
Part 1 of the COVA Study is a Phase II exploratory proof of concept study providing preliminary data on the safety, tolerability and activity of Sarconeos in 50 hospitalised patients with Covid-19-related acute respiratory failure.
Part 2 is a Phase III pivotal randomised study and will evaluate the safety and efficacy of Sarconeos on the respiratory function in 310 Covid-19 patients, which includes 50 patients from Part 1.
The company noted that the interim analysis data from Part 1 is anticipated in the first quarter while full study results from Part 1 and 2 are expected in the second quarter of this year.
Last September, Biophytis started the enrolment and dosing of patients in a Phase II/III clinical trial to assess Sarconeos (BIO101) for treating respiratory failure due to Covid-19.