The COVA study aims at evaluating therapeutic efficacy and safety of Sarconeos (BIO101) as a treatment to prevent further respiratory deterioration in patients who experience severe respiratory distress due to COVID-19.
The Coronavirus SARS-CoV-2 can cause Acute Respiratory Distress Syndrome (ARDS) by disrupting the renin angiotensin system (RAS), which has a key role in regulating respiratory function. It is believed that SARS-CoV-2 enters the lung cells using the Angiotensin 2 Converting Enzyme (ACE-2), a key enzyme in the RAS, inhibiting the system’s protective arm.
Sarconeos (BIO101) activates the MAS receptor, a key component of the protective arm of the RAS, and has been shown to significantly improve respiratory function in several preclinical models.
Sarconeos (BIO101) has demonstrated a good safety profile during the SARA development program which is evaluating its ability to improve muscle function in frail elderly patients with sarcopenia ( SARA-INT the phase 2b study of Sarconeos (BIO101) in Sarcopeniawas completed in 2021). Sarconeos (BIO101) is also being developed to improve the respiratory function of children with Duchenne muscular dystrophy (DMD). COVA is based on clinical and preclinical data from Sarconeos (BIO101) in these neuromuscular diseases.
Objectives
In the context of the world crisis caused by COVID-19, the aim of Biophytis is to bring in the shortest time possible a medical treatment that will help to prevent further respiratory deterioration in individuals who present severe respiratory manifestations of COVID-19. Biophytis is bringing its expertise in ageing science to a patient population particularly susceptible to such deterioration, as old age and frailty are important risk factors.
In 2022, Biophytis was able to complete the Phase 2-3 COVA clinical trial and report positive results from the study demonstrating the effect of Sarconeos (BIO101) in the treatment of severe forms of COVID-19. The statistically significant 44% reduction in the risk of respiratory failure or early death is a very important outcome for patients as COVID-19 continues to be a major health issue, with over 40,000 deaths in 2022 according to Santé Publique France.
The primary endpoint is confirmation of the effect of Sarconeos (BIO101) in preventing respiratory deterioration. Secondary and exploratory endpoints include safety and tolerability, improvement in lung function in COVID-19 patients and effects on biomarkers associated with the RAS, the target of Sarconeos (BIO101).