Covid-19 has completely transformed our society on a global scale and has had a devastating effect particularly on the frail elderly. We have been very eager to answer the calls from our industry, as well as national and international organizations to join the global effort to fight this pandemic.
The COVA study evaluates the therapeutic efficacy and the safety of Sarconeos (BIO101) as a treatment to prevent further respiratory deterioration in patients who experience severe respiratory manifestations 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) is a drug candidate that 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 (the phase 2b study, SARA-INT, is currently underway). 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
In the context of the world crisis caused by Covid-19, the aim of Biophytis is to bring in the shortest time a medical treatment that will help to prevent further respiratory deterioration in individuals who present with 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.
Our objective is to apply for a fast-tracked conditional approval, based on a phase 2/3 study that will recruit several hundred participants worldwide.
the study received approval and recruiting patients in the US, Brazil, France, Belgium and the UK.
The study is titled: Testing the efficacy and safety of BIO101, for the prevention if respiratory deterioration, in patients with SARS-CoV-2 pneumonia (COVA study) and is designed as a phase 2/3, randomized, double-blind, placebo-controlled, adaptive and seamless study, with 2 parts:
Recruitment will occur into 2 parts, with similar features. A total of 310 (potentially increased by 50%, i.e. up to 465, based on an interim analysis) Patients with COVID19, who have developed severe respiratory symptoms within the last 14 days. Recruitment to part 1 (first 50 participants) have been completed and is now ongoing into part 2.
The primary endpoint is all cause mortality or signs of respiratory failure, secondary and exploratory endpoints will include, safety and tolerability, improvements in COVID-19 patients’ respiratory function, and effects on biomarkers associated with the Renin-Angiotensin System (RAS), target of Sarconeos (BIO101), will also be evaluated.
The study will go through 2 interim analyses. The first, on the participants of part 1, to assess the safety of BIO101 and provide an initial indication of activity. The second will take place after 50% of the study participants are recruited (155) and will include a futility analysis and reassessment of the sample size. These analyses are conducted by an independent data-monitoring committee (iDMC).