BIOPHYTIS confirms that Sarconeos modulates the Renin-Angiotensin System and activates muscular metabolism in the SARA-PK clinical trial

PARIS, May 03, 2017 (GLOBE NEWSWIRE) -- BIOPHYTIS (Alternext Paris:ALBPS), a biotechnology company specializing in the development of drug candidates to treat age-related diseases, announced it presented at the ICFSR the full results of Sarconeos (BIO101), the Company’s lead drug candidate for the treatment of sarcopenia, in the SARA-PK clinical study. The analysis of pharmacodynamics data showed that some biomarkers of muscle metabolism or key hormones of the Renin Angiotensin System (RAS) were modulated in accordance with the mechanism of action of Sarconeos. Three other scientific studies were also presented, BIOPHYTIS being the most active biotech company at the 7^th International Conference on Frailty & Sarcopenia Research, held April 27-29^th 2017 in Barcelona, Spain.

Stanislas Veillet, CEO of BIOPHYTIS, said: “Our analysis of biomarkers of muscle anabolism and RAS activation demonstrate the potential of Sarconeos in the treatment of Sarcopenia. We are very proud to be the most active biotech company presenting at this conference, sharing with the community of scientists and clinicians our results and clinical plan. The international SARA-OBS/INT Phase 2b clinical study is just starting, it is probably the largest therapeutic trial ever done in this new indication.”

The SARA-PK study was executed between August and November 2016. The analysis of pharmacodynamics data confirmed that observed changes on biomarkers of muscular metabolism (creatine kinase, myoglobin, etc.) and of the Renin-Angiotensin System (renin, adolsterone, etc.) are consistent with the mechanism of action of the investigational drug candidate (Sarconeos), which stimulates anabolism in skeletal muscles through the activation of MAS receptor. The activation of MAS receptor stimulates protein synthesis and counteracts proteolysis in skeletal muscles thereby compensating the loss of muscle mass, muscle strength, and mobility losses associated with aging in animal models of Sarcopenia.

The study aimed at assessing the safety and evaluating the pharmacokinetics and pharmacodynamics of Sarconeos in healthy young and older volunteers following single and multiple ascending oral doses for 14 days.

• The Single Ascending Dose (SAD) is a staggered design involving the administering of Sarconeos orally to 24 subjects from 2 age groups – 2 cohorts of adults aged 18 to 55 at escalating doses of 100 mg to 1400 mg, and 1 cohort of adults aged 65 to 85 at 1400 mg.
• The Multiple Ascending Dose (MAD) is a design of 3 selected doses of Sarconeos of 350 mg qd; 350 mg bid and 450 mg bid administered to 3 panels of 10 adults aged 65 to 85 over 14 days.

SARA-PK safety, pharmacokinetics and pharmacodynamics results allow us to confirm Sarconeos’ favourable therapeutic window and to define the two doses which will be tested in SARA-INT, the Sarconeos Phase 2b interventional study, provided it is authorized by the relevant regulatory agencies: 175 mg bid and 350 mg bid

Three other scientific studies were presented at the 7th International Conference on Frailty & Sarcopenia Research, demonstrating the energy and originality of BIOPHYTIS’ scientific and medical teams, among the most active in the industry, which today are focused on the launch of the SARA-OBS/INT international clinical study.

• BIO103, a second-generation compound for the treatment of sarcopenia. From anabolic properties to the reversion of aging-related functional loss.
• Loss of muscular function as a result of aging, obesity and immobilization: a mouse model for pharmacological intervention.
• Patient Reported Outcomes (ePROs) – SarQoL, SF-36 and TSD-OC - in ageing related Sarcopenia. SARA-OBS, a six-month observational clinical trial.   
  

For more information on the ICFSR program please see: http://www.frailty-sarcopenia.com/programme.pdf

About SARCONEOS
Sarconeos is a first in class drug candidate based on the activation of the MAS receptor (major player of the renin-angiotensin system) restoring muscular anabolism, inhibiting myostatin, and that has demonstrated meaningful activity in animal models of muscular dystrophies. Sarconeos is developed in the treatment of sarcopenia, an age-related degeneration of skeletal muscle, leading to loss of mobility in elderly people. This condition, for which no medical treatment currently exists, was first described in 1993 and has entered the International Classification of Diseases (M62.84) in 2016. It 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: http://www.biophytis.com 

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.