Brazil Ministry of Health, BFARM & FDA approve and See the efficacy and safety of BIO101, for the prevention of respiratory deterioration, in patients with COVID-19 pneumonia

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As of December, 1st, 2020, coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2, resulted in more than 2 972 917 deaths worldwide and death toll is still increasing exponentially. Many COVID-19 infected people are asymptomatic or experience moderate symptoms and recover without medical intervention. However, older people and those with comorbid hypertension, diabetes, obesity, or heart disease are at higher risk of mortality. Because current therapeutic options for COVID-19 patients are limited specifically for this elderly population at risk, Biophytis is developing BIO101 (20-hydroxyecdysone, a Mas receptor activator) as a new treatment for managing patients with SARS-CoV-2 infection at the severe stage.

The angiotensin converting enzyme 2 (ACE2) serves as a receptor for SARS-CoV-2. Interaction between ACE2 and SARS-CoV2 spike protein seems to alter the function of ACE2, a key player in the renin-angiotensin system (RAS). The clinical picture of COVID-19 includes acute respiratory distress syndrome (ARDS), cardiomyopathy, multiorgan dysfunction and shock, all of which might result from an imbalance of the RAS. We propose that RAS balance could be restored in COVID-19 patients through MasR activation downstream of ACE2 activity, with 20-hydroxyecdysone (BIO101) a non-peptidic Mas receptor (MasR) activator.

Indeed, MasR activation by 20-hydroxyecdysone harbours anti-inflammatory, anti-thrombotic, and anti-fibrotic properties. BIO101, a 97% pharmaceutical grade 20-hydroxyecdysone could then offer a new therapeutic option by improving the respiratory function and ultimately promoting survival in COVID-19 patients that develop severe forms of this devastating disease. Therefore, the objective of this COVA study is to evaluate the safety and efficacy of BIO101, whose active principle is 20-hydroxyecdysone, in COVID-19 patients with severe pneumonia.

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.

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