(BFM Bourse) – The biopharmaceutical company has obtained the green light from the FDA to launch its phase III study SARA-31 for its potential treatment against sarcopenia. Biophytis obtained similar authorization from Belgium last month.
An upward start to the week for Biophytis, whose stock rose another 5.7% to 0.015 euros around 10:30 a.m., after having soared by 30% in the first exchanges on Monday. This buyer flow is to be linked with the latest advances by the biotechnology company for its potential treatment in age-related diseases, particularly neuromuscular diseases.
Biophytis announced this Monday morning that it had obtained authorization from the Food and Drug Administration (FDA) – the American health authority – for the launch of a clinical program in the United States. This is SARA-31, its very first phase III study (last stage of clinical trials before potential marketing) in sarcopenia.
With age, a decline in muscle mass is inevitable. But from a certain stage of reduction in muscle mass and performance, we speak of sarcopenia. This weakening accelerates the loss of autonomy, increases the risk of falls and fractures leading to immobilization which, in turn, aggravates sarcopenia, etc.
And it is to treat this age-related degeneration that Biophytis is developing Sarconeos (BIO101), a drug candidate derived from medicinal plants called phytoecdysteroids, used as toning agents in different pharmacopoeias. It also aims to slow down respiratory deterioration in patients with Duchenne muscular dystrophy and is also being studied in the treatment of respiratory failure linked to Covid-19.
“The FDA’s authorization suggests that authorities are increasingly aware of the growing need for effective treatments against a major disease in an aging society,” said Stanislas Veillet, Chairman and CEO of Biophytis.
A similar authorization obtained this summer in Belgium
The green light granted by the FDA is in line with the expectations of Biophytis, which hoped for such a response during the third quarter. Above all, it complements the positive opinion from the Belgian authorities obtained this summer for its phase III SARA-31 study in sarcopenia. Biophytis explains that it must still obtain authorization from the ethics committees in the countries concerned to be able to launch this study.
For the actual start of the American study, this is planned for 2024, indicates Biophytis, which adds that its launch will depend on the conclusion of partnership agreements and the financial resources of the company.
In its note dedicated to Biophytis, Invest Securities recalls that the company previously declared that it was not considering conducting this study alone while its financial resources do not allow it to bear the costs of such a clinical program. “Its project is to form a partnership with a Pharma company in order to launch this pivotal study and finalize the trials as part of this program in sarcopenia among others,” adds the design office.
Although studies are still underway for Sarconeos, Biophytis has already prepared the ground to secure the production of the active ingredient of its flagship drug candidate. Last July, the biopharmaceutical company signed a partnership to this effect with Seqens, a French company specializing in chemistry for the pharmaceutical industry, for the production of the active ingredient in Sarconeos. This agreement will serve as a springboard for “putting its product on the potential market in France”, Invest Securities then estimated in a previous note dedicated to the signing of this agreement with Seqens.
Sabrina Sadgui – ©2023 BFM Bourse
Are you following this action?
Receive all the information on BIOPHYTIS in real time: