BIOPHYTIS received regulatory authorizations to conduct SARA-OBS study in sarcopenia patients

ROMAINVILLE, France, Nov. 22, 2016 -- 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.

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 et 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: http://www.BIOPHYTIS.com 

BIOPHYTIS is eligible for the SMEs scheme

Disclaimer
This press release contains certain forward-looking statements. Although the Company believes its expectations are based on reasonable assumptions, these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those anticipated. For a discussion of risks and uncertainties which could cause the Company's actual results, financial condition, performance or achievements to differ from those contained in the forward looking statements, please refer to the Risk Factors (“Facteurs de Risque”) section of the Listing Prospectus upon the admission of Company’s shares for trading on the regulated market Alternext of Euronext Paris filed with the AMF, which is available on the AMF website (www.amf-france.org) or on BIOPHYTIS’ website (www.BIOPHYTIS.com).

This press release and the information contained herein do not constitute an offer to sell or a solicitation of an offer to buy or subscribe to shares in BIOPHYTIS in any country. Items in this press release may contain forward-looking statements involving risks and uncertainties. The Company’s actual results could differ substantially from those anticipated in these statements owing to various risk factors which are described in the Company’s prospectus. This press release has been prepared in 5 both French and English. In the event of any differences between the two texts, the French language version shall supersede.