New clinical data on the investigational compound in GENFIT
Lille, France; Cambridge, MA; November 02, 2021 – GENFIT (Nasdaq and Euronext: GNFT), an advanced-stage biopharmaceutical company dedicated to improving the lives of patients with metabolic and chronic liver disease, today announced that it will present new clinical data on its investigational compound elafibranor to the American Association for the Study of Liver Diseases (AASLD). Liver Meeting® 2021 to be held from November 12 to 15, 2021.
The data comes after the completion of an open-label, non-randomized, parallel-group phase 1 trial. The objectives were to assess the pharmacokinetics, safety and tolerability of elafibranor in patients with hepatic impairment and to advise of the potential need for dose adjustment in patients with hepatic impairment.
In the study, 20 subjects with hepatic impairment and 10 healthy volunteers with normal hepatic function received a single oral dose of elafibranor 120 mg.
Elafibranor was generally safe and well tolerated in this study, which is consistent with previous studies. Pharmacokinetic data suggest that the total drug exposure of elafibranor and its active metabolite is not significantly altered in patients with hepatic impairment. Increases in unbound drug in severe hepatic impairment are not expected to be clinically significant. As such, dose adjustment of elafibranor is unlikely to be necessary in patients with hepatic impairment.
Title: Pharmacokinetics and Safety of Elafibranor in Subjects with Hepatic Impairment
Presentation type: ePoster
Poster Number: 1287
Authors: Benoit Noël et al.
Session title: Human cholestatic and autoimmune liver diseases: PBC / PSC and other cholestatic diseases
The Liver Meeting® organized by AASLD is one of the most important hepatology congresses in the medical and scientific community. It brings together more than 10,000 scientists, gastroenterologists and hepatologists from all over the world. Due to the COVID-19 pandemic, the 2021 edition of The Liver Meeting has become The Liver Meeting Digital Experience, an online forum for the exchange of revolutionary ideas and discoveries in basic, translational and clinical research on diseases of the liver and bile ducts. , and in liver transplantation.
GENFIT is an advanced stage biopharmaceutical company dedicated to improving the lives of patients with severe chronic liver disease. GENFIT is a pioneer in the field of nuclear receptor drug discovery, with a rich history and a strong scientific legacy spanning more than two decades.
Today, GENFIT has a robust and diverse pipeline, using different compounds and technologies evaluated at different stages of development and in different liver diseases.
Relying on its internal strengths and internal expertise, GENFIT’s R&D focuses on cholestatic diseases and acute chronic liver failure (ACLF): two therapeutic areas with significant unmet medical needs. Currently, the ELATIVE ™ phase 3 clinical trial evaluating elafibranor in patients with primary biliary cholangitis (PBC) is ongoing following a successful phase 2 clinical trial. Patient recruitment is expected to be completed in the first quarter of 2022 and baseline data is expected to be announced between the end of the first quarter and the end of the second quarter 2023. A phase 2 clinical development program is also underway with elafibranor in primary. Sclerosing cholangitis (SCC) and a phase 1 clinical program with nitazoxanide in ACLF has been initiated.
As part of GENFIT’s global approach to the clinical management of patients with liver disease, the Company is also developing NIS4®, a new non-invasive blood diagnostic technology, which could allow easier identification of patients with liver disease. NASH at risk. Since May 2021, Labcorp® has been marketing NASHnext ™, optimized by NIS4®, for clinical use. GENFIT also continues to explore opportunities to obtain formal marketing authorization for an in vitro diagnostic (IVD) test.
GENFIT has offices in Lille and Paris, France, and Cambridge, MA, USA. GENFIT is a company listed on the Nasdaq Global Select Market and on compartment B of the regulated market of Euronext in Paris (Nasdaq and Euronext: GNFT). www.genfit.com
Elafibranor, GENFIT’s leading therapeutic candidate, is currently being evaluated in ELATIVE ™, a Phase 3 clinical trial to assess its efficacy and safety in patients with PBC. Elafibranor is a first-class, once-daily oral drug candidate, acting via double agonism of alpha / delta receptors activated by peroxisome proliferators. Data from a phase 2 clinical trial demonstrated that elafibranor has the potential to become an effective treatment for PBC, a rare liver disease. The FDA has granted it a revolutionary therapy designation in this indication. Elafibranor is an investigational compound that has not been reviewed or approved by a regulatory authority.
GENFIT FORWARD-LOOKING STATEMENTS
This press release contains certain forward-looking statements regarding GENFIT, including those within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the pharmacokinetics, safety and tolerability of elafibranor in healthy subjects and in subjects with hepatic impairment, the improbability of dose adjustment of elafibranor in subjects with hepatic impairment, and time to read data and enrollment of patients in the ELATIVE ™ trial. The use of certain words, including “consider”, “contemplate”, “think”, “aim”, “expect”, “understand”, “should”, “aspire”, “estimate”, “believe” “,” Wish “,” may “,” could “,” allow “,” seek “,” encourage “or” have confidence “or (as the case may be) the negative forms of these terms or any other variation of these terms or other similar terms their meaning is intended to identify forward-looking statements. Although the Company believes that its projections are based on the reasonable expectations and assumptions of the Company’s management, these forward-looking statements are subject to numerous known and unknown risks and uncertainties, which could cause actual results to differ materially. of those expressed, implied or proposed by forward-looking statements. These risks and uncertainties include, among others, the uncertainties inherent in research and development, including with respect to the safety, biomarkers, progress and results of its ongoing and planned clinical trials, review and outcomes. regulatory approvals for its drug and diagnostic candidates, the impact of the ongoing COVID-19 pandemic, currency fluctuations and the Company’s continued ability to raise capital to finance its development, as well as the risks and uncertainties discussed or identified in the Company’s public documents with France Authority from Markets Financial (“AMF”), including those listed in chapter 2 “Main risks and uncertainties” of the Company’s 2020 Universal Registration Document filed with the AMF on April 23, 2021 under number D.21-0350, available on the Company’s website (www.genfit.com) and on the AMF’s website (www.amf-france.org), and public documents and reports filed with the Securities and Exchange Commission (“SEC ) Of the United States, including the Company’s 2020 Annual Report on Form 20 -F filed with the SEC on April 23, 2021 and subsequent filings and reports filed with the AMF or the SEC, or otherwise rendered public by the Company. In addition, even if the results, performance, financial position and liquidity of the Company, as well as the development of the sector in which it operates are in accordance with these forward-looking statements, they may not be predictive of the results or developments of future periods. These forward-looking statements speak only as of the date of publication of this document. Except as required by applicable law, the Company assumes no obligation to update or revise any forward-looking information or statement, whether as a result of new information, future events or otherwise. .
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New clinical data on GENFIT’s investigational compound Elafibranor to be presented at AASLD The Liver Meeting®