Regulatory Filings • May 31, 2016
Regulatory Filings
Open in ViewerOpens in native device viewer
Press release
Romainville, May 31, 2016, 6pm – BIOPHYTIS (Alternext Paris: ALBPS), biotechnology company specialized in the development of drug candidates to treat aging diseases, announces it will participate to BIO International Convention from June 6th to 9th in San Francisco.
Stanislas Veillet, Chief Executive Officer de BIOPHYTIS, declares: "Participating in BIO this year is very important for BIOPHYTIS, especially a few weeks after we announced that we would double the size of our clinical trials. Patients will be recruited in Europe and in the USA to obtain approval from both the European Medical Agency (EMA) and the Food & Drug Agency (FDA) for sarcopenia and AMD treatments. Following the opening of a subsidiary in Cambridge last fall, and the enlargement of our Scientific Advisory Board to American KOLs, this new step in our strategy shows that BIOPHYTIS is strengthening its leading status on pathologies with no treatment and for which being present on the US market is key."
Follow this link to watch Stanislas Veillet's video message: http://www.biophytis.com/en/stanislas-veillet-bio-2016
The BIO International Convention is the largest global event for the biotechnology industry and attracts the biggest names in biotech, offers key networking and partnering opportunities, and provides insights and inspiration on the major trends affecting the industry.
The Phase 2b SARA study relates to a drug candidate for treatment of sarcopenic obesity: Sarconeos (formerly BIO101). BIOPHYTIS has now selected eight main clinical investigation centers in France and Belgium, where 180 sarcopenic patients will be recruited. In Europe, the Toulouse Gérontopôle will be the main center of investigation. In the United States, the Company has initiated the selection of three centers of investigation, with the principal one being Tufts University in Boston. The goal is to recruit 120 sarcopenic patients.
The objective of this large international clinical study will be to evaluate the effect of the Sarconeos product on the muscular function of sarcopenic persons aged over 65 years old, in accordance with criteria proposed by the Foundation for the National Institute of Health (FNIH). Two Sarconeos doses will be compared to a placebo: Sarconeos 100 mg and Sarconeos 350 mg.
Due to the extension of testing to the North American continent, the investigation phase of the SARA study is planned to start in the first half of 2017.
Before that, two clinical trials will be conducted in the second semester of 2016:
More specifically, the 300 subjects are to be older than 50 years old and suffer from intermediate stage dry AMD. They will be recruited in France, in at least one other European country, and in the United States, in particular at the Massachusetts Eye and Ear Infirmary at Harvard Medical School in Boston.
The patients enrolled in the study will be divided into three groups: Macuneos 100 mg, Macuneos 350 mg, and a placebo. The investigation phase will last 18 months, with interim data reported at 9 months. It was decided to increase the number of patients with respect to the initial protocol, by adding a group of 120 patients in the United States. This increases the chance of success of the study, which is to start in the first half of 2018 (as soon as the regulatory authorizations are obtained).
***
More information on: http://www.biophytis.com
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).
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
Building tools?
Free accounts include 100 API calls/year for testing.
Have a question? We'll get back to you promptly.