BIOPHYTIS Received Regulatory Authorizations To Conduct SARA-OBS Study In Sarcopenia Patients

ROMAINVILLE, France, Nov. 22, 2016 (GLOBE NEWSWIRE) -- BIOPHYTIS (Alternext Paris:ALBPS) a biotechnology company specialized in the development of drug candidates to treat aging diseases, announces it has received regulatory authorizations in France and Belgium to conduct the SARA-OBS study in sarcopenia patients.

Stanislas Veillet, CEO of BIOPHYTIS, said: "We are pleased to obtain these first authorizations, allowing us to initiate recruitment for SARA-OBS in France and Belgium. Additional regulatory authorizations are being pursued in Italy and in the U.S."

SARA-OBS is a 6-month clinical observational study in over 300 sarcopenia patients that will monitor multiple parameters of disease severity and progression. Data from SARA-OBS will provide a better characterization of sarcopenia patients that will be later on enrolled in a Phase 2b study, SARA-INT.

SARA-OBS will recruit and monitor 300 sarcopenia patients for 6 months in 8 clinical centers in the U.S. and Europe. Patients, over 65 years old, will be recruited using the criteria defined by the Foundation for the National Institutes of Health; i.e.: low Appendicular Lean Mass (ALM BMI < 0.8 for men and < 0.5 for women) and mobility impairment, assessed by Short Physical Performance Battery index  (SPPB = 8). Sarcopenia patients will be monitored for 6 months, with measurements occurring at inclusion and after 6 months. Primary end-points will be: 6-minute walk test and 500 m test. Secondary end-points will include ALM BMI, SPPB, muscle weakness (grip test, knee extension), and plasmatic biomarkers.

Patients enrolled in SARA-OBS will not receive study medication or placebo, but may be enrolled in SARA-INT after the second SARA-OBS visit, if consent is obtained. Inclusion data will be used to better describe the target patient population in the regulatory files of Sarconeos (IMPD and IND) and will provide more robust base-line data at initiation of the Phase 2b SARA-INT clinical study.