BIOPHYTIS Announces Successful Completion of SARA-PK Clinical Study for Sarconeos in Sarcopenia Confirming Safety Profile

ROMAINVILLE, France, Nov. 30, 2016 -- BIOPHYTIS (Alternext Paris:ALBPS), a biotechnology company specialized in the development of drug candidates to treat aging diseases, announces the successful completion of its SARA-PK clinical study for Sarconeos, lead drug candidate for the treatment of sarcopenia. The results of the study, conducted in young and elderly healthy volunteers, confirmed Sarconeos’ appropriate safety profile, with no serious adverse events associated with the administration of Sarconeos.

Stanislas Veillet, Chief Executive Officer of BIOPHYTIS, said: “The successful outcome of the SARA-PK study is an important milestone for BIOPHYTIS and our Sarconeos development program. We have strong confidence in Sarconeos’ safety profile and will move forward with our Phase 2b SARA-INT study in 2017, as planned.  We believe Sarconeos is well differentiated and has significant potential to treat sarcopenia, a debilitating muscle wasting disease that is largely untreatable today.”

The objective of the SARA-PK study was to assess the safety, tolerability and pharmacokinetic profile of Sarconeos in elderly healthy volunteers (> 65 years old).  The study was conducted in two phases: single ascending dose (SAD) administration, and multiple ascending dose (MAD) administration.  The MAD portion of the study was aimed at evaluating the safety and pharmacokinetics of Sarconeos in 30 older subjects, following three ascending oral administrations daily for 14 days (350mg/day, 700 mg/day then 900 mg/day).  Both phases of the SARA-PK study have now been successfully completed.

The results of the SARA-PK study will be used to select the two doses of Sarconeos for further evaluation in the Phase 2b SARA-INT trial, which BIOPHYTIS intends to initiate in the first half of 2017.

The complete results of the SARA-PK study, in particular the pharmacokinetic profile of Sarconeos, will be available in the first quarter of 2017. Initial study results will be presented at the 9th International Conference on Sarcopenia, Cachexia, and muscle Wasting Diseases (SCWD), being held December 10-11, 2016, in Berlin, Germany.

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 discovered and 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 Equity Saving Plans PEA-PME.

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 both French and English. In the event of any differences between the two texts, the French language version shall supersede.