Biophytis Plans Phase 2/3 Clinical Trial Investigating the Efficacy of Sarconeos (BIO101) in COVID-19 Patients with ARDS

Jul 6, 2020 | ARDS, COVID-19, Investor Watch, News, SARS-CoV-2

Biophytis Plans Phase 23 Clinical Trial Investigating the Efficacy of Sarconeos (BIO101) in COVID-19 Patients with ARDS

Biophytis SA (ALBPS) is a clinical stage biotechnology company specializing in the development of drug candidates for the treatment of aged related diseases, such as neuromuscular diseases. The U.S. Food and Drug Administration (FDA) accepted its investigational new drug (IND) application to proceed with its COVA clinical development program. This Phase 2/3 study focuses on the assessment of Sarconeos (BIO101) as a potential treatment for acute respiratory failure associated with COVID-19. When SARS-CoV-2, the virus behind COVID-19 progresses to a severe or critical stage, the risk for acute respiratory deficiency leads to a high probability of morbidity and mortality. Biophytis is addressing an incredibly dangerous situation; a safe and effective drug is desperately needed for patients that do progress into the severe to critical state  with acute respiratory deficiency. The company also just secured €6.1 million from institutional investors in both Europe and the United States.

The Condition

Acute respiratory distress syndrome (ARDS) is a type of respiratory failure characterized by rapid onset of widespread inflammation in the lungs. Symptoms include shortness of breath, rapid breathing and bluish skin coloration. For those who survive, a decreased quality of life is common. COVID-19 has been found to trigger this dangerous condition, especially in groups with certain risk factors, such as age and comorbidities.

Although there was a recent breakthrough in the RECOVERY trial, where dexamethasone was found to improve survival rates of hospitalized COVID-19 patients receiving oxygen or on a ventilator, benefits were observed only in patients requiring respiratory support. The investigators measured a statistically insignificant benefit for those patient that didn’t require breathing support. The full data set needs to be published for wider analysis.

The Investigational Drug

Sarconeos (BIO101) is an orally administered small molecule in development for the treatment of neuromuscular diseases. Based on results from cellular and animal studies, the company believes this investigational candidate stimulates biological resilience through activation of the MAS receptor and may have the potential to improve muscle function and preserve strength, mobility and respiratory capacity in various age-related and muscular condition.

During preclinical studies (e.g. in lab and animals), the French sponsor found that the investigational product activated the MAS receptor in muscle cells, which actually is a key component of the Renin-Angiotensin System (RAS). The RAS is a fundamental endocrine system known to control fluid balance, blood pressure and cardio-vascular function. The RAS is also a factor in the regulation of smooth, cardiac and skeletal muscle metabolism and plays a key role In muscle function and mobility in disease states.

Note that the drug is involved with another clinical trial called SARA-INT in the United States. Initiated in 2018 and still recruiting patients, this Phase 2 study involves investigating the safety and efficacy of Sarconeos (BIO101) in older patients suffering from age-related sarcopenia (including sarcopenic obesity) and at risk of mobility disability.

A pediatric formulation of Sarconeos (BIO101) is being developed for the treatment of Duchenne Press release Muscular Dystrophy (DMD). The company plans to start the clinical development (MYODA) in H2 2020. As reported here, Sarconeos (BIO101) is also being developed as a treatment for COVID-19.

Key Rational for the Study

As mentioned above, once patients infected with COVID-19 progress to a state where acute respiratory deficiency emerges, the patient is endangered and the death rates become far higher. There is an urgent need for a dependable, predictable, safe and efficacious drug that can help a patient fight deadly results of the Acute Respiratory Distress Syndrome (ARDS). Conveying the rational of the study, CEO Stanislas Veillet declared, “There is an urgent need for therapies to help patients with COVID-19 Acute Respiratory Distress Syndrome (ARDS) given the continuing rapid spread of SARS-CoV-2 and limited therapeutic options. With FDA clearance, we intend to initiate a clinical trial to evaluate Sarconeos (BIO101) in patients with acute respiratory failure associated with COVID-19. The elderly and those with comorbidities are at highest risk of death from SARS-CoV-2. We have already initiated the work to start this key Phase 2/3 trial as soon as possible in the US, and in the European countries where we received approval, and will update the market shortly on our planned timelines.”

The Study

The COVA clinical program is designed to evaluate the efficacy and safety of Sarconeos (BIO101) as a treatment of the respiratory deterioration in COVID-19 patients with severe respiratory failure. The pivotal, international clinical trial will be conducted in two parts, including 1) objective to assess treatment safety and provide an indication of activity of Sarconeos (BIO101), in 50 hospitalized COVID-19 patients suffering from acute respiratory deficiency; and 2) investigate the efficacy of Sarconeos (BIO101) on the respiratory function of around 300 additional patients.

The Company

Founded in 2006, the company develops drug candidates targets diseases of aging. Using its own technology and know-how, Biophytis has commenced clinical development of innovative therapeutics to restore the muscular and visual functions in diseases with significant unmet medical needs. Specifically, the company is advancing two proprietary drug candidates into mid-state clinical testing, inducing Sarconeos (BIO101) to treat sarcopenic obesity (and targeting COVID-19 ARDS) and Macueneos (BIO201) to treat dry age-related macular degeneration (AMD).

The Company has received approval from FAMHP (Belgium), the MHRA (UK) and US FDA to begin the Phase 2/3 clinical trial (COVA) to evaluate Sarconeos (BIO101) as a potential treatment for respiratory failure associated with COVID-19. The Company also filed a clinical trial application with the French regulatory agency, ANSM in France. They’re based in Paris, France, and Cambridge, Massachusetts. The company’s common shares are listed on the Euronext Growth Paris market (Ticker: ALBPS -ISIN: FR0012816825). They also just raised €6.1 million in a private placement, which attracted the interest of institutional investors in both Europe and the Untied States. In the U.S., H.C. Wainwright & Co LLC served as the exclusive placing agent while Invest Securities served this function in Europe. The company leveraged the services of Invest Corporate Finance

Call to ActonTrialSite News monitors COVID-19 investigational therapies and Biophytis is on the list. For updates as they materialize, sign up for the daily newsletter.

Source: Biophytis