Therapy Areas: Inflammatory Diseases
Biophytis Enrolls First Patient in Brazil in COVA, a Multinational Phase 2/3 Clinical Trial with Sarconeos for the Treatment of Patients with COVID-19 Related Respiratory Failure
26 October 2020 - - The first patient in Brazil has been dosed at Hospital e Maternidade Celso Pierro - PUCCAMP in Campinas in COVA, a Phase 2/3 Clinical Trial with Sarconeos (BIO101) for the treatment of patients with COVID-19-related respiratory failure, French biotechnology company Biophytis SA (Euronext Growth Paris: ALBPS) said.

The multinational trial is progressing at pace with ten centres now open to recruit patients in Belgium, France, Brazil and in the US.

The COVA clinical program ( identifier NCT04472728) is a Phase 2/3, randomized, double-blind, placebo-controlled, adaptive and group sequential study assessing Sarconeos (BIO101) in patients aged 45 and older, infected with SARS-CoV-2.

It is designed to evaluate the efficacy and the safety of Sarconeos (BIO101) as a treatment to prevent further deterioration in patients with COVID-19-related respiratory failure.

The objective is to prevent them from being admitted to the intensive care unit and requiring ventilation.

This pivotal multinational clinical trial is being conducted in two parts, the first of which will assess the treatment safety and provide an indication of activity of Sarconeos (BIO101) in 50 hospitalized COVID-19 patients suffering from acute respiratory deficiency.

The second part of the study will investigate the efficacy of Sarconeos (BIO101) on the respiratory function of an additional 260 COVID-19 patients.

The primary endpoint of the COVA study is the proportion of all-cause mortality and respiratory deterioration within up to a 28-day period.

Secondary endpoints include records of improvement, worsening and hospital discharge, functional scales and the biomarkers associated with the mechanism of action of Sarconeos (BIO101) and inflammation.

Biophytis is a clinical-stage biotechnology company specialized in the development of drug candidates to slow down degenerative processes and improve functional abilities in patients with age-related diseases, including neuromuscular diseases.

Sarconeos (BIO101), its leading drug candidate, is a small molecule, administered orally, currently in clinical Phase 2b in sarcopenia (SARA-INT) in the United States and Europe.

A pediatric formulation of Sarconeos (BIO101) is being developed for the treatment of Duchenne Muscular Dystrophy. The company plans to start the clinical development (MYODA) in H2 2020.

Sarconeos (BIO101) is also being developed as a treatment for patients with COVID-19 related respiratory failure in a Phase 2/3 clinical study in the United States, Europe and Latin America.

The company is based in Paris, France, and Cambridge, Massachusetts.


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