Regulatory Filings • Sep 11, 2017
Regulatory Filings
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Press release
Paris (France), September 11, 2017 Paris (France), 7.45am BIOPHYTIS (Euronext Growth Paris: ALBPS), a biotechnology company specializing in the development of drug candidates to treat age-related diseases, today has announced new results clarify the photoprotective effect of Macuneos (BIO201, clinical stage drugcandidate) through its specific activation of PPAR receptors, at the Euretina International Congress held from 7 to 10 September 2017 in Barcelona, Spain.
Stanislas Veillet, CEO of BIOPHYTIS, says: "The results presented at Euretina clarify the mechanism of action of Macuneos (BIO201) in the photoprotection of the retina and confirm the role of the PPAR receptors in the pathophysiology of AMD. These results encourage us to conduct the MACA clinical program without delay, and to start the MACA-PK study shortly. The MACA-PK protocol has been optimized to evaluate the effects of Macuneos on the visual function of patients with AMD, for which we expect results in 2018."
Fontaine V.1 , Monteiro E.1 , Fournie M.1 , On S.2 , Serova M.2 , Dilda P.2 and Lafont R.2
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The MACA-PK study is a phase I/IIa clinical study, whose protocol has been optimized to study the safety, pharmacokinetics and pharmacodynamics of Macuneos in healthy volunteers in a Belgian clinical center in 2017, and in patients suffering from dry AMD recruited in 5 ophthalmological centers in France and in Belgium, including the CIC of l'Hôpital des Quinze-Vingt in Paris, in 2018. Biophytis has called on the CRO SGS Life Science Services to conduct this international multicentric clinical study.
Macuneos (BIO201) is the first representative of a new class of drug candidates, agonists of nuclear receptor PPAR. Macuneos protects retinal pigment epithelium: Biophytis has shown in animal models a protection of retinal cells against phototoxic effects of A2E in the presence of blue light (oxidative stress), a reduction in accumulation of A2E, and eventually a slowdown of the degenerative process of the retina. Macuneos is a drug candidate against the dry form of AMD: AMD affects the central part of the retina, called the macula, causing severe visual impairment and irreversible loss of central vision beyond 60 years old. Macuneos is in tablet form (once per day), containing 100 mg or 350 mg of active Pharmaceutical Ingredient (API).
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 needs. Specifically, the company is advancing two lead products into mid-stage clinical testing this year: Sarconeos (BIO101) to treat sarcopenic obesity and Macuneos (BIO201) to treat dry age-related macular degeneration (AMD).
The business model of BIOPHYTIS is to ensure the conduct of the project until clinical activity in the patient is proven, then to license the technologies in order to continue the development in partnership with a pharmaceutical laboratory.
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 Euronext Growth market of Euronext Paris (ALBPS; ISIN: FR0012816825).
For more information: http://www.biophytis.com
Follow us on Twitter @biophytis
BIOPHYTIS is eligible for the SMEs scheme
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 Euronext Growth 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 forwardlooking 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 both French and English. In the event of any differences between the two texts, the French language version shall prevail.
| BIOPHYTIS | Citigate Dewe Rogerson | LifeSci Advisors |
|---|---|---|
| Stanislas Veillet | International press & investors | Chris Maggos |
| CEO | Laurence Bault/Antoine Denry | Managing Director Europe |
| [email protected] | [email protected]/[email protected] | [email protected] |
| Tel: +33 (0) 1 41 83 66 00 | Tel: +33 (0) 1 53 32 84 78 | Tel: +41 79 367 6254 |
| Mob: +33 (0) 6 64 12 53 61 |
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