Regulatory Filings • Jul 29, 2016
Regulatory Filings
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Press release
Romainville, July 29th , 2016 – BIOPHYTIS (Alternext Paris : ALBPS), a biotechnology company specialized in the development of drug candidates to treat aging diseases, announced that is has received approval of bpifrance for a 1.1 million euros innovation loan to finance the pharmacokinetic trial of Sarconeos (SARA-PK). Sarconeos is a drug candidate in the treatment of sarcopenic obesity.
The conditional advance granted by bpifrance will complement the funding of the SARA-PK trial. SARA-PK received approval from the Belgian Federal Agency for Medicines and Health Products (FAMHP) and the Ethics Committee in Antwerp, enabling its initiation.
This trial will be conducted in two phases during the second half of 2016 and will assess pharmacokinetics and safety of Sarconeos in elderly healthy volunteers (> 65 years old). The results of the trial will support the clinical and regulatory filing for Sarconeos, required for authorization of the SARA-INT clinical study (Phase 2b) initiation, currently scheduled to start in the first half of 2017 in target countries (France, Belgium, Italy and USA).
With this funding, Biophytis will be able to fully conduct the SARA-PK study while preparing the next stages of Sarconeos' development.
Stanislas Veillet, Chief Executive Officer of BIOPHYTIS, declares: « We are pleased to obtain this financing, which demonstrates the support and interest our research is generating. This trial is the first step towards a first treatment for sarcopenia, a pathology affecting 50 million people worldwide and for which no treatment currently exists. »
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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
Follow us on Twitter: @biophytis
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 Presse & Relations Investisseurs Bruno ARABIAN [email protected] Tel : +33 (0) 1 83 62 34 84 Mob : +33 (0) 6 87 88 47 26
Citigate Dewe Rogerson Presse internationale 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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