Direct intervention with hospitalized patients suffering from COVID-19 to prevent respiratory failure – which requires the use of the famous ventilator, or even admission to intensive care units – is the objective of the new clinical program set up by Biophytis. The French biotechnology company is specializing in the development of treatments for neuromuscular diseases, in collaboration with the Pitié-Salpêtrière hospital in Paris.
Founded in 2006 and listed on Euronext Paris in 2015, the company announced Tuesday morning, April 7th, the launch of a new clinical development program called COVA. The program is based on the company’s flagship compound Sarconeos (BIO101) as a potential treatment for respiratory failure associated with COVID-19.
This program, through a phase 2/3 trial (a clinical trial that could lead directly to the submission of an application for approval to the drug agency prior to marketing) will consist of evaluating the therapeutic efficacy and safety of Sarconeos (BIO101) in the treatment of acute respiratory distress syndrome (ARDS), the most lethal symptom associated with COVID-19. As soon as the National Agency for the Safety of Medicines (ANSM) gives the go-ahead, the trial can begin, starting with Pitié-Salpêtrière, before being extended to Belgium and the United States in particular.
Sarconeos is an experimental treatment
Sarconeos is an experimental drug derived from medicinal plants called phytoecdysteroids, used as toning agents in various pharmacopeias. This compound was first tested for its ability to improve muscle function in frail elderly patients with sarcopenia, a form of age-related muscle degeneration. The disease is affecting, depending on the source, between 6% and 22% of people over 65 years of age. In addition, Biophytis recently received the green light for a phase 2/3 study to test its efficacy in preserving the respiratory function of children with Duchenne muscular dystrophy.
“COVID-19 has completely transformed our society on a global scale and has had a devastating effect, particularly on the health of the frail elderly. We wish to respond to the call from our industry and national and international organizations to join the global effort to fight this pandemic. Sarconeos (BIO101) has demonstrated its ability to restore normal lung function in several experimental models by activating the renin-angiotensin system, the very system that is attacked by the SARS-Cov-2 virus. In the absence of a vaccine and antiviral treatment with proven efficacy, it could offer a drug treatment for acute respiratory failure in hospitalized COVID-19 patients. Sarconeos could potentially limit the use of mechanical ventilation and promoting people’s potential recovery,” said Stanislas Veillet, co-founder and CEO of Biophytis.
“We hope for a favorable response from the ANSM to be able to start this study in France in order to respond as quickly as possible to this health emergency,” Veillet added.
At the same time, the company announced a strengthening of its financial structure through the refinancing of its current bond issue, on more advantageous terms, and an issue of share subscription warrants (BSA), with a priority period granted to the company’s current shareholders. The latter will be able to subscribe to 3 BSAs for 16 shares held on April 8th, each BSA then allowing them to subscribe over the next five years to one new share at a unit price of €0.27 for a period of 5 years from the date of settlement and delivery, at an exercise price of €0.27 (17% above the last closing price).
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