Regulatory Filings • Jul 25, 2016
Regulatory Filings
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Press release
Romainville, 25 July 2016, 18:00 – BIOPHYTIS (Alternext Paris: ALBPS), a biotechnology company specialized in development of drug candidates to treat aging diseases, today announces that the Belgian regulator authorized the planned pharmacokinetics study of its lead product, Sarconeos (SARA-PK study), which is in development to treat sarcopenic obesity.
The Belgian Federal Agency for Medicines and Health Products (FAMHP) and the Ethics Committee in Antwerp gave their authorization regarding the initiation of the SARA-PK study to qualify pharmacokinetics and safety of Sarconeos in elderly healthy volunteers (> 65 years old). This study will be conducted during the second half of 2016 in two phases: the first phase will compare pharmacokinetics in elder and young volunteers after escalating single dose administrations of Sarconeos; the second phase will study pharmacokinetics and safety on elder healthy volunteers (30 volunteers) after daily administrations of Sarconeos for 14 days, at 3 doses. The results of the study will complete the clinical and regulatory file for Sarconeos, which is required for authorization to initiate the Phase IIb "SARA INT" clinical study, currently scheduled to start in the first half of 2017 in France, Belgium, Italy and USA.
Stanislas Veillet, Chief Executive Officer of BIOPHYTIS, declares: "The authorization from Belgian health authorities to initiate the SARA-PK study is an important step in the development of the first treatment for sarcopenia. Obtaining this authorization is in line with the new development plan unveiled last April and allows us to move with confidence towards the initiation of the SARA international study expected in the first semester of 2017."
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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.
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
Milestones Press and investor relations Bruno ARABIAN [email protected] Tel : +33 (0) 1 83 62 34 84 Mob : +33 (0) 6 87 88 47 26
Citigate Dewe Rogerson International press 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
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