Shares in Genfit popped 29% in pre-market trading on Wednesday after the late-stage biopharma company announced “positive” results from the Phase 2 clinical trial testing its elafibranor therapy in patients with Primary Biliary Cholangitis (PBC), a form of liver disease.
Genfit (GNFT), which develops therapies for metabolic and liver diseases, said that the results from the Phase 2 trial of elafibranor showed a clinically relevant improvement on the primary and composite biochemical endpoints and a positive trend on pruritus improvement. At the same time, the therapy had a favorable tolerability profile.
Based on the data, Genfit will conduct a longer-term, larger scale pivotal Phase 3 study to evaluate elafibranor in patients with PBC. Elafibranor is an investigational compound that has not been reviewed or approved by any regulatory authority. In addition, Genfit is also developing NIS4, a non-invasive blood-based diagnostic technology which seeks to enable easier identification of patients who are at risk of NASH (Non-alcoholic Steatohepatitis) liver disease.
“These data support the potential for elafibranor as novel treatment in PBC and confirm the rationale of evaluating our compound in this disease in a pivotal Phase 3 trial,” Genfit CMO Carol Addy said. “PBC remains a disease with significant unmet medical needs, mostly because a substantial number of patients have insufficient response or cannot benefit from existing therapies.”
“We seek to replicate the Phase 2 efficacy and safety results in our Phase 3 clinical trial in PBC, in the hope that we may improve the prospect of new treatment for patients,” Addy added.
In September 2020, Genfit started the enrollment of its global pivotal Phase 3 clinical trial to evaluate the efficacy and safety of elafibranor in patients suffering from PBC. The randomized study will evaluate 150 patients following 52 weeks of treatment. Topline data are scheduled to be released in the first quarter of 2023. (See Genfit stock analysis on TipRanks).
H.C. Wainwright analyst Ed Arce last month reiterated a Hold rating on the stock with an $8 price target, as he doesn’t see “any meaningful catalysts” from the company’s elafibranor and NIS4 programs for at least the next 12 months.
Overall, the stock has a Moderate Buy consensus rating from the Street based on 1 Buy, 1 Hold, and 1 Sell. After shares lost 70% of their value over the past year, the average analyst price target of $7.16 suggests 35% upside potential could be lying ahead.
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