BIOPHYTIS Opens First Clinical Centers In Europe For Patient Study

Biophytis (EPA: ALBPS) announced the first clinical centers dedicated its six-month SARA-OBS study in Europe have opened and they are now recruiting patients.
As quoted in the press release:

The first clinical centers have opened and started the screening of patients with sarcopenia in Belgium, (Liège, Prof. Bruyère, Liège University), in France (Toulouse, Profs. Vellas & Rolland, Gérontopole). It will soon start in Italy (Roma, Profs. Donini & Gnessi, La Sapienza University). Regulatory approvals to start SARA-OBS study in these countries have been granted in 2016.

Two clinical centers in the USA (Boston, Prof. Fielding, Tufts University School of Medecine ; Gainesville, Prof. Pahor, Institute on Aging, College of Medecine, University of Florida) should open and start recruitment in the coming weeks once final regulatory approval is received, being acknowledged that the clinical design of SARA-OBS study has already been approved by the American regulatory authority.

A total of 300 patients with sarcopenia will be recruited in 8 clinical centers for the SARA-OBS study. Those sarcopenic patients will constitute the basic patient population for the phase 2b SARA-INT study.

Stanislas Veillet, CEO of BIOPHYTIS, stated: “We are pleased to announce that the first clinical centers have opened for the SARA-OBS study in Europe. We will open two new clinical centers in the US in the coming weeks, once final approval is granted.  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 2b SARA-INT clinical study.”

SARA-OBS is a 6-months clinical observational study, conducted in over 300 sarcopenia patients, that will monitor multiple parameters of disease severity and progression. Sarcopenic patients will be monitored for 6 months. For this purpose the e-health SARA-data platform has been designed and implemented for collecting both qualitative and quantitative data data. This unique and flexible tool provides proprietary and standardized data via remotely connected devices and allows secure communication and continuous data collection from home.

Patients’ mobility and muscular quality will be assessed, based on the following criteria: 6-minute walk test, muscle strength (grip test), physical performance (SPPB test), body composition and plasmatic parameters. Data from SARA-OBS will provide a better characterization of sarcopenic patients that will be later enrolled in a Phase 2b study, SARA-INT.

The phase 2b of SARA-INT will be initiated 6 months after the enrollment of the first patient in the SARA-OBS study. Patients in the SARA-OBS study will ultimately be enrolled in the phase 2b study of SARA-INT, when consent is given and necessary authorizations are granted.

ABOUT SARCONEOS: Sarconeos is the first representative of a new class of drug candidates, based on the activation of the MAS receptor (major player of the renin-angiotensin system) stimulating anabolism in the muscle, inhibitor of myostatin and favoring muscle mass development in animal models of muscular dystrophies. Sarconeos is developed in the treatment of sarcopenia, an age-related degeneration of skeletal muscle and strength, leading to a loss of mobility in elderly people.  This new pathology, for which no medical treatment currently exists, was first described in 1993 and just entered the WHO International Classification of Diseases (M62.84), affects more than 50 million people worldwide.

About BIOPHYTIS:
BIOPHYTIS SA (www.biophytis.com), founded in 2006, develops drug candidates targeting diseases of aging. Using its technology and know-how, BIOPHYTIS has begun clinical development of innovative therapeutics to restore the muscular and visual functions in diseases with significant unmet medical need. Specifically, the company is advancing two lead products into mid-stage clinical testing next year: Sarconeos (BIO101) to treat sarcopenic obesity and Macuneos (BIO201) to treat dry age-related macular degeneration (AMD). The company was founded in partnership with researchers at the UPMC (Pierre and Marie Curie University) and also collaborates with scientists at the Institute of Myology, and the Vision Institute.

BIOPHYTIS is listed on the Alternext market of Euronext Paris (ALBPS; ISIN: FR0012816825).

For more information: https://www.biophytis.com

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Click here to read the full press release.