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PARIS, May 11, 2017 -- BIOPHYTIS (Alternext Paris:ALBPS), a biotechnology company specialized in the development of drug candidates to treat ageing diseases, has announced that it has received the approval from the US regulatory authorities for the recruitment of sarcopenia patients in the observational study SARA-OBS on Sarconeos. It has therefore been able to open the two clinical centers and start the recruitment of sarcopenia patients in the United States. These patients, if they give their consent, could participate in the clinical trial of phase 2b SARA-INT, on Sarconeos.
Stanislas Veillet, Chief Executive Officer of BIOPHYTIS, said: “We are delighted to announce the recruitment of the first patient in the SARA-OBS clinical study in the United States. The US clinical centers of Boston and Gainesville are now open and recruiting patients. These centers are specialized in sarcopenia patients care, led by internationally renowned clinicians, and ideally complete our European clinical network. It marks an important step of our development strategy in the US, our primary market, which was announced one year ago. We are now focusing on the preparation of the interventional phase, SARA-INT, which will follow on this observational study.”
BIOPHYTIS has obtained the authorization of the regulatory authorities to start the SARA-OBS clinical study in sarcopenia. The first two clinical centers have therefore been opened, in Boston at the Jean Mayer Human Nutrition Research Center on Aging, Tufts University with head investigator Professor Roger Fielding, and in Gainesville at the Institute of Aging, University of Florida, with investigator Professor Marco Pahor.
The recruitment of the 300 patients in the 8 clinical centers opened in Europe (France, Belgium and Italy) and the United States has now begun. Sarcopenia patients will be monitored for 6 months before being possibly included in the interventional phase 2b SARA-INT study, after obtaining their consent.
The opening of centers in the United States is a critical marker of the development strategy initiated a year ago. It consists in a doubling of the size of the clinical study by recruiting patients in the US (the most important market for BIOPHYTIS in terms of number of patients), opening of a subsidiary in Boston, recruitment of reputable clinicians, in particular Roger A Fielding who joined BIOPHYTIS’ Scientific Advisory Board, and is the head researcher of the SARA-OBS/SARA-INT study.
To know more about the SARA clinical program and Sarcopenia, you may also watch the introductory video by following this link: http://www.biophytis.com/en/actualites/SARA-ICFSR-2017/
About SARA-OBS: SARA-OBS is a 6-months clinical observational study, conducted in over 300 sarcopenia patients recruited in 8 clinical centers in Europe and the United States. Patients’ mobility and muscular quality will be assessed, based on the following criteria: 6-minute walk test, mobility (SPPB test), muscle strength (grip test), body composition and plasmatic parameters. Data from SARA-OBS will provide a better characterization of the target population for the Sarconeos treatment. Patients in the SARA-OBS study will be included in the phase 2b study of SARA-INT at the end of 6 months, once consent is given.
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 this 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: http://www.biophytis.com
Follow us on Twitter @biophytis
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.
BIOPHYTIS Stanislas VEILLET CEO [email protected] Tel: +33 (0) 1 41 83 66 00 Citigate Dewe Rogerson International media Laurence BAULT/Antoine DENRY [email protected]/[email protected] Tel: +33 (0)1 53 32 84 78 Mob: +33(0)6 64 12 53 61 LifeSci Advisors Chris MAGGOS Managing Director, Europe [email protected] Tel: +41 79 367 6254
