Biophytis: FDA agrees to a phase 3 study


(CercleFinance.com) – Biophytis shares were among the biggest risers on the Paris market Monday morning after the American FDA gave the green light to the launch of a phase 3 study in sarcopenia.

At 11:15 a.m., the stock jumped 7.8% while at the same time, the CAC Mid & Small advanced 0.6%.

In a press release published this morning, the biotechnology company indicates that it has received authorization from the American health authority for the launch in the United States of the first phase 3 study ever launched in sarcopenia, an age-related disease. which weakens the muscles.

This authorization completes the positive opinion already obtained this summer from the Belgian authorities, even if it remains to obtain authorization from the ethics committees in the countries concerned to be able to launch this study.

The actual start of the study on Sarconeos, planned for 2024, will depend on the conclusion of partnership agreements and the financial resources available to the company.

‘Recall that the company previously declared that it was not considering conducting this study alone, its financial resources not allowing it to bear the costs of such a clinical program’, react the analysts at Invest Securities.

‘Its project is to form a partnership with a pharmaceutical company in order to launch this pivotal study and finalize the trials as part of this program in sarcopenia among others’, they add.

The objective is to evaluate the effectiveness and safety of this small molecule in the treatment of 900 sarcopenic patients aged over 65 years at risk of motor disability, who will be treated between one and three years.

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