Regulatory Filings • Oct 2, 2015
Regulatory Filings
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2015 Press release
Lille (France), Cambridge (Massachusetts, United States), October 2 nd , 2015 – GENFIT (Euronext: GNFT; ISIN: FR0004163111), a biopharmaceutical company at the forefront of developing therapeutic and diagnostic solutions in metabolic and inflammatory diseases, that notably affect the liver or the gastrointestinal system, today announces the presentation of Elafibranor results during the annual meeting of the AASLD, "The Liver Meeting", in San Francisco from November 13-17, 2015. e n f i t .
The results of the GOLDEN-505 Phase 2b study, showing the efficacy of Elafibranor (GFT505) for the treatment of NASH, have been selected by the scientific review committee for presentation in a Presidential Plenary session. f r
Professor Vlad Ratziu, principal investigator and international coordinator of the GOLDEN-505 study, will describe the efficacy and safety results during a plenary session presentation:
Monday, November 16 from 11am – 12:30pm
"AN INTERNATIONAL, PHASE 2 RANDOMIZED CONTROLLED TRIAL OF THE DUAL PPAR ALPHA-DELTA AGONIST GFT505 IN ADULT PATIENTS WITH NASH" V Ratziu et al. (Abstract 105)
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 both French and English. In the event of any differences between the two texts, the French language version shall supersede.
Additionally, the AASLD has selected two other abstracts for presentation on the GOLDEN-505 study:
"BENEFICIAL EFFECTS OF THE DUAL PPAR ALPHA-DELTA AGONIST, GFT505, ON HEPATIC AND CARDIOMETABOLIC MARKERS IN ADULT NASH PATIENTS" SA Harrison et al. (Abstract 162)
"THE HEPATIC AND EXTRA-HEPATIC PROFILE OF RESOLUTION OF STEATOHEPATITIS INDUCED BY GFT-505" A Sanyal et al. (Abstract 2145)
One additional poster will be presented illustrating the efficacy of Elafibranor in a novel disease model of NASH that mirrors the histological effects observed in the GOLDEN-505 study. This model enables a better description of the mechanism of therapeutic action of Elafibranor:
"GFT505 (ELAFIBRANOR) PREVENTS NONALCOHOLIC STEATOHEPATITIS (NASH), HEPATIC FIBROSIS AND HEPATOCARCINOMA IN A NEW PRECLINICAL MODEL" B Noel et al. (Abstract 974)
Jean-François Mouney, Chairman and Chief Executive Officer of GENFIT, declared: "The AASLD meeting will constitute an important moment for GENFIT, both with a strong corporate and clinical presence at the meeting, also concurrent with the finalization of the design of our NASH phase 3 trial. With two oral presentations, including the Presidential Plenary, this will be an excellent opportunity for continued discussions with medical partners, clinicians, and important stakeholders who are eagerly awaiting further development and commercialization of a product that is both effective and safe for the growing numbers of patients in need of a treatment for NASH."
GENFIT is a biopharmaceutical company focused on the Discovery and Development of drug candidates in fields of high medical need due to a lack of suitable treatment and an increasing number of patients worldwide. GENFIT's R&D efforts are focused on contributing to bringing new medicines to market for patients with metabolic, inflammatory, autoimmune and fibrotic diseases, that affect the liver (such as NASH - Nonalcoholic steatohepatitis) or the bowel (such as the inflammatory bowel disease). GENFIT implements mutually beneficial approaches that combine novel treatments and biomarkers; its research programs have resulted in the creation of a rich and diversified pipeline of drug candidates, including GENFIT's lead proprietary compound, GFT505/Elafibranor, that has completed a positive Phase 2b study in NASH and is currently
GENFIT | 885 Avenue Eugène Avinée, 59120 Loos, France | +333 2016 4000 | www.genfit.com
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 both French and English. In the event of any differences between the two texts, the French language version shall supersede.
launching a Phase 3 study. With facilities in Lille, France, and Cambridge, MA (USA), the Company has approximately 90 employees. GENFIT is a public company listed in compartment B of Euronext's regulated market in Paris (Euronext: GNFT; ISIN: FR0004163111). www.genfit.com
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 of Euronext Paris filed with the AMF, which is available on the AMF website (www.amf-france.org) or on GENFIT's website (www.genfit.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 GENFIT in any country.
GENFIT | Jean-François Mouney - CEO & Chairman of the Management Board | Ph. +333 2016 4000
MILESTONES – Relation Presse | Bruno Arabian | Ph. +331 8362 3484 / +336 8788 4726 – [email protected]
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