Longevity biotechnology company Biophytis has applied to the US FDA seeking authorization to commence a Phase 3 study for the treatment of sarcopenia – the age-related loss of muscle mass and strength. The company says the trial of its lead drug candidate Sarconeos (BIO101) will be the first-ever Phase 3 study conducted in sarcopenia.
Sarconeos is a small molecule being developed for conditions such as sarcopenia, Duchenne muscular dystrophy and Covid-19. Following the positive outcomes of a Phase 2b study and productive discussions with health authorities in 2022, Biophytis has now initiated the Phase 3 program by filing an application with the FDA. A similar submission has also been made to the European Medicines Agency.
The primary objective of the Phase 3 study is to assess the safety and effectiveness of Sarconeos in treating sarcopenic patients at risk of mobility disability. The trial will include approximately 900 patients aged over 65 years who exhibit severe sarcopenia. The primary endpoint of the study will be the evaluation of Major Mobility Disability risk, measured by the ability to walk 400m in under 15 minutes over time. Secondary endpoints will include walking speed, handgrip strength and patient-reported quality of life.
“Following the success of SARA-INT’s Phase 2b clinical trial, the filing of an application with the EMA in mid-May and with the FDA today for the launch of a Phase 3 clinical trial in sarcopenia is a major milestone in the development of our drug candidate,” said Stanislas Veillet, Chairman and CEO of Biophytis. “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 3 clinical development program in this indication.”
Biophytis anticipates receiving a response from regulatory authorities in the third quarter of 2023, which would allow the company to commence the study in the United States. The principal investigator for the study will be Dr Roger A Fielding, who leads the Nutrition, Physiology, Exercise and Sarcopenia Laboratory at Tufts University in Boston.
