Lille (France), Cambridge (Massachusetts, United States), May 14, 2019 – GENFIT (Euronext: GNFT – Nasdaq: GNFT) a late-stage biopharmaceutical company dedicated to the discovery and development of innovative therapeutic and diagnostic solutions in metabolic and liver related diseases, today announced that the Data Safety Monitoring Board (DSMB) issued a new positive recommendation for the continuation, without any modifications, of the RESOLVE-IT Phase 3 trial evaluating elafibranor in NASH. This sixth planned review by the DSMB reiterates previous positive guidance and saw no safety concerns.
The 36-month positive DSMB safety review supports GENFIT’s positive momentum in continuing the RESOLVE-IT study. Top-line interim results, based on the primary endpoint of “NASH resolution without worsening of fibrosis”, are expected to be announced at the end of 2019. If positive, the interim data would support accelerated approval (Subpart H) from the U.S. Food and Drug Administration (FDA), and conditional approval from the European Medicines Agency (EMA), as early as 2020. Elafibranor is currently the only late-stage, Phase 3 therapy undergoing investigation for “NASH resolution without the worsening of fibrosis”. As such, elafibranor could be the first available therapy able to eliminate the underlying cause of NASH disease progression. Elafibranor has received fast track designation from the FDA for the treatment of NASH.
Dr Pascal Birman, Deputy Chief Medical Officer of GENFIT, commented: “This sixth positive DSMB review continues to support GENFIT’s development of elafibranor in NASH. NASH is considered a chronic condition and therefore a clean safety profile is crucial for any drug candidate aiming to address the unmet clinical needs related to this pathology. In addition, the safety profile gives us further confidence as we explore elafibranor in the clinical setting, specifically for pediatric NASH – a naïve patient population and a trial we expect to begin enrolling shortly – and PBC, a program we plan to move into a Phase 3 clinical trial later this year.”
Elafibranor is GENFIT’s lead pipeline product candidate. Elafibranor is an oral, once-daily, first-in-class drug acting via dual peroxisome proliferator-activated alpha/delta pathways developed to treat, in particular, nonalcoholic steatohepatitis (NASH). GENFIT believes, based on clinical results to date, that elafibranor has the potential to address multiple facets of NASH, including inflammation, insulin sensitivity, lipid/metabolic profile, and liver markers. Phase 2 clinical trial results have also shown that elafibranor may be an effective treatment for PBC, a rare liver disease.
RESOLVE-IT is a phase 3 study evaluating the efficacy and safety of elafibranor 120mg versus placebo in patients with nonalcoholic steatohepatitis (NASH) and fibrosis. It is a multicenter, randomized, double-blind, placebo-controlled study with 2 arms. It is conducted under Subpart H (FDA) and conditional approval (EMA). Treatment duration until interim analysis for accelerated approval is 72 weeks.
“NASH” is a liver disease characterized by an accumulation of fat (lipid droplets), along with inflammation and degeneration of hepatocytes. The disease is associated with long term risk of progression to cirrhosis, a state where liver function is diminished, leading to liver insufficiency, and also progression to liver cancer.
GENFIT is a late-stage biopharmaceutical company dedicated to the discovery and development of innovative therapeutic and diagnostic solutions in metabolic and liver related diseases where there are considerable unmet medical needs, corresponding to a lack of approved treatments. GENFIT is a leader in the field of nuclear receptor-based drug discovery with a rich history and strong scientific heritage spanning almost two decades. Its most advanced drug candidate, elafibranor, is currently being evaluated in a pivotal Phase 3 clinical trial (“RESOLVE-IT”) as a potential treatment for NASH, and GENFIT plans to initiate a Phase 3 clinical trial in PBC later this year following its positive Phase 2 results. As part of GENFIT’s comprehensive approach to clinical management of NASH patients, the company is also developing a new, non-invasive and easy-to-access blood-based in vitro diagnostic test to identify patients with NASH who may be appropriate candidates for drug therapy. With facilities in Lille and Paris, France, and Cambridge, MA, USA, the Company has approximately 150 employees. GENFIT is a public company listed on the Nasdaq Global Select Market and in compartment B of Euronext’s regulated market in Paris (Nasdaq and Euronext: GNFT). www.genfit.com