Biophytis S.A.

Regulatory Filings • Mar 11, 2016

Press Release

BIOPHYTIS receives positive scientific advice on SARCOB BIO101 clinical development plan from Belgian regulatory authority

Paris (France), Boston (Massachusetts), March 11, 2016 – BIOPHYTIS (Alternext Paris: ALBPS), a geriatric medicine company advancing clinical stage drug-candidates to treat sarcopenic obesity and age related macular degeneration (AMD), announced today that it received scientific advice from the Belgian Federal Agency for Medicines and Health Products (FAHMP) regarding its clinical development plan for SARCOB BIO101, which is being studied for treatment of patients suffering from sarcopenic obesity (i.e. loss of muscle functionality in obese people), an increasingly common issue, most often associated with aging.

The FAHMP opinion was requested by BIOPHYTIS in November 2015 and represents an important milestone in the regulatory and clinical development of SARCOB BIO101. It is the first step of the regulatory process by which BIOPHYTIS seeks to obtain approvals of several agencies (FAHMP, ANSM, EMA, FDA) necessary to proceed with a Phase 2B trial of SARCOB BIO101 in about 180 patients suffering from sarcopenic obesity, currently under preparation to be conducted in France and Belgium. The plan proposed by BIOPHYTIS includes a number of supplementary preliminary studies, among which a pharmacokinetics study after multiple administration in healthy older volunteers that will be conducted this summer in Belgium by SGS Life Science.

"We are delighted to have received the first positive opinion on our clinical and regulatory development plan for SARCOB BIO101," said Stanislas Veillet, Chief Executive Officer of BIOPHYTIS. "This is the first time that a regulatory agency has considered a clinical development plan for a drug candidate to treat sarcopenic obesity, a pathology that affects millions of people who currently have no satisfactory therapeutic options."

BIOPHYTIS has selected SGS as its regulatory partner for this project. SGS Life Science is a leading international CRO (Contract Research Organization) with more than 35 years of experience in clinical research. SGS Group (Geneva-CH) is the world's leading inspection, verification, testing and certification company.

Sarcopenic obesity is increasingly common in aging people. Sarcob BIO101 is the first drug candidate that may address the underlying biological processes that cause sarcopenic obesity. It is an orally available selective MAS receptor agonist, which has demonstrated efficacy in preclinical proof of concept studies. Specifically it has increased the anabolic growth of muscle (i.e. increased muscle fiber diameter, increased protein density and inhibition of myostatin) – in models of sarcopenic obesity.

To learn more, please visit: http://www.BIOPHYTIS.com/en/pipeline/plateforme-Sarcob/

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. In addition to Sarcob BIO101, the company is advancing Maculia (BIO201) to treat dry age-related macular degeneration (AMD) into midstage (Phase IIb) clinical testing.

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 eligible for the French PEA-PME regime.

BIOPHYTIS Stanislas VEILLET CEO contact@BIOPHYTIS.com Tel : +33 (0) 1 41 83 66 00

Milestones Presse & Relations Investisseurs Bruno ARABIAN barabian@milestones.fr Tel : +33 (0) 1 83 62 34 84 Mob : +33 (0) 6 87 88 47 26

LifeSci Advisors Chris MAGGOS Managing Director, Europe chris@lifesciadvisors.com Tel : +41 79 367 6254