French biotechnology firm Biophytis has opened its first clinical centres in Europe and started patient enrolment for SARA-OBS clinical trial of sarconeos to treat sarcopenia.
Sarconeos is being developed to stimulate anabolism in the muscle, inhibit myostatin and promote muscle mass development.
With regulatory approvals obtained last year, the trial's first clinical sites have been opened in Belgium and France, while a new site will soon be opened in Italy.
The six months observational SARA-OBS trial will examine various parameters of disease severity and progression in a total of 300 patients in eight clinical centres.
Biophytis chief executive officer Stanislas Veillet said: “We are pleased to announce that the first clinical centres have opened for the SARA-OBS study in Europe.
"The network of leading clinicians that we have gathered in the past months, at the cutting-edge of science in Sarcopenia research, is key for the success of the Phase IIb SARA-INT clinical study."
Upon receiving the final regulatory approval, Biophytis plans to open and begin recruitment at two clinical centres in the US over the coming weeks.
The firm has designed and implemented e-health SARA-data platform for collecting both qualitative and quantitative data through remotely connected devices.
The trial will examine the mobility and muscular quality of the patients based on criteria such as six-minute walk test, muscle strength (grip test), physical performance (SPPB), body composition and plasmatic parameters.
Data from this trial will be considered as a base for the Phase IIb SARA-INT trial, which will be initiated six months after the recruitment of the first patient in the SARA-OBS.