Biophytis has announced that it has filed for approval from the US Food and Drug Administration (FDA) to launch SARA-31, which will be the first Phase III study in sarcopenia.

SARA-31 will evaluate the efficacy and safety of Sarconeos (BIO101) in treating sarcopenic patients at risk of mobility disability.

An age-related condition characterised by progressive loss of muscle mass and strength, sarcopenia affects 10%-16% of the elderly globally. The primary treatment for the condition is exercise and resistance or strength training.

The SARA-31 study follows promising results from a Phase IIb study and discussions with health authorities in 2022. Patients in the Phase IIb study of Sarconeos at the highest dose (350mg bid) showed meaningful improvement in the 400m walk test, meeting the study’s primary endpoint.

Requirements for Phase III

The Phase III study will involve approximately 900 patients over 65 years of age with severe sarcopenia, low walking speed and low grip strength. Patients will receive a minimum of 12 months and a maximum of 36 months of treatment. They will receive either 350mg of Sarconeos or a placebo twice daily.

The primary endpoint will measure the ability to walk 400m in less than 15 minutes. Secondary endpoints will also be assessed, including walking speed, handgrip strength and quality of life. The FDA application comes shortly after submission to the European Medicines Agency (EMA) and Biophytis expects a response during Q3 2023.

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By GlobalData

Biophytis CEO and chairman Stanislas Veillet commented: “Following the success of SARA-INT’s Phase IIb clinical trial, the filing of an application with the EMA in mid-May and with the FDA today for the launch of a Phase III clinical trial in sarcopenia is a major milestone in the development of our drug candidate.

“We are pioneers in the field of sarcopenia and intend to be the first company to launch, in partnership with global or regional pharmaceutical companies, a Phase III clinical development program in this indication.”

Other drugs in development

GlobalData’s Pharmaceutical Intelligence Centre shows no competing drugs that have been marketed or are at Phase III trial in sarcopenia. There are six Phase II and two Phase I competing drugs.

GlobalData is the parent company of the Clinical Trials Arena.

Sarconeos is also in development for Duchenne muscular dystrophy and acute respiratory distress syndrome (ARDS) associated with Covid-19 pneumonia and Covid-19-induced respiratory failure. The small molecule drug candidate is a phytoecdysone, which targets Mas-related G protein-coupled receptor, developed based on the SARCOB platform.