Regulatory Filings • Jun 26, 2019
Regulatory Filings
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Paris (France), Cambridge (Massachusetts, United States), June 26, 2019 - Biophytis SA (Euronext Growth Paris: ALBPS), a clinical-stage biotechnology company focused on the development of therapeutics for age-related diseases, today announced that it has presented one oral and one poster presentation at the MaculART meeting in Paris, France held from June 23-25, 2019.
The poster presentation highlights the effects and potential mechanism of action of Macuneos (BIO201), the Company's preclinical drug candidate for the treatment of retinopathies, including dry age-related macular degeneration (AMD) and Stargardt disease. In cellular models, the Company observed that Macuneos (BIO201) inhibits A2E-induced transactivation of peroxisome proliferator activated receptors (PPARs) and shows promising effects on retinal pigmented epithelial (RPE) cells survival, A2E accumulation and inflammation. Additionally, the Company observed that Macuneos (BIO201) does not transactivate (canonical activity) any of the PPARs including PPARα, PPARβ/δ, and PPARγ. In animal models, the Company observed that Macuneos (BIO201) reduces A2E accumulation and promotes photoreceptor survival and visual function in ABCA4-/- RDH8-/- mice. A2E is a sub-product of the visual pigment cycle that in the presence of blue-light is phototoxic to the retina and is known to be a key factor for the retina degeneration in AMD and Stargardt disease.
The oral presentation titled "Design of a randomized, placebo-controlled phase one trial to evaluate the safety, pharmacokinetics and pharmacodynamics of BIO201 developed for the treatment of AMD and Stargardt Disease" highlights the guiding principles regarding the clinical design of a Phase 1 trial for Macuneos (BIO201) in healthy volunteers and was presented by Serge Camelo of Biophytis on June 24, 2019 at 5:46 CEST.
Stanislas Veillet, Ph.D., chief executive officer of Biophytis said, "These preclinical results and initial discussion regarding the potential design of a Phase 1 clinical trial support our plan to hold a scientific advice meeting with EU regulatory agencies in the second half of 2019 regarding clinical development of Sarconeos (BIO201) for the potential treatment of dry AMD and Stargardt disease."
Biophytis is a clinical-stage biotechnology company focused on the development of therapeutics that slow the degenerative processes and improve functional outcomes for patients suffering from age-related diseases. Our therapeutic approach is aimed at targeting and activating key biological resilience pathways that can protect against and counteract the effects of the multiple biological and environmental stresses thatlead to age-related diseases. Our lead drug candidate, Sarconeos (BIO101), is an orally administered small molecule in development for the treatment of neuromuscular diseases, including sarcopenia and Duchenne muscular dystrophy (DMD). Our second drug candidate, Macuneos (BIO201), is an orally administered small molecule in development for the treatment of retinal diseases, including dry agerelated macular degeneration (AMD) and Stargardt disease. Biophytis is headquartered in Paris, France, and has offices in Cambridge, Massachusetts. The Company's ordinary shares are listed on Euronext Growth Paris(Ticker: ALBPS - ISIN: FR0012816825). For more information please visit www.biophytis.com.
This press release contains forward-looking statements. Forward-looking statements include all statements that are not historical facts. In some cases, you can identify these forward-looking statements
by the use of words such as "outlook," "believes," "expects," "potential," "continues," "may," "will," "should," "could," "seeks," "predicts," "intends," "trends," "plans," "estimates," "anticipates" or the negative version of these words or other comparable words. These forward-looking statements include any statements regarding our preclinical and clinical data, development plans and timelines. For a discussion of the risks and uncertainties that could cause the Company's actual results, financial condition, performance or achievements to differ from those contained in the Company's forward looking statements, please consult the Risk Factors section of the Company's registration document and other regulatory filings filed with the French Autorité des Marchés Financiers (AMF), which are available on the AMF website (www.amf-france.org) and at 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 securities of Biophytis in any country. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements and estimates, which speak only as of the date hereof. Other than as required by applicable law, Biophytis undertakes no obligation to update or revise the information contained in this press release. 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.
Daniel Schneiderman, CFO [email protected] Tel: +1 (857) 220-9720
LifeSci Public Relations Cherilyn Cecchini, M.D. [email protected] Tel: +1 (646) 876-5196
Citigate Dewe Rogerson Antoine Denry [email protected] Tel: +33 (0) 1 53 32 84 78
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