(Boursier.com) — Inventive rises 5.5% to 3.60 euros this Friday, while the biopharmaceutical company specializing in the clinical development of small molecules administered orally for the treatment of steatohepatitis associated with metabolic dysfunction (“MASH”), also known under the name of non-alcoholic steatohepatitis (“NASH”) and other diseases with significant unmet medical need, announced the positive recommendation of the fourth meeting of the Data Monitoring Committee (DMC) to continue the Phase III clinical study , NATiV3, evaluating lanifibranor in patients with MASH/NASH without modification of the current protocol.
The DMC, comprised of a panel of independent experts, conducted its review based on unmasked review of safety data from more than 900 patients randomized to the primary cohort, which included patients with MASH/NASH and fibrosis stages F2 and F3, as well as in the exploratory cohort, including patients with MASH/NASH and fibrosis stages F1 to F4 who are histologically ineligible for the main cohort.
Among the more than 900 patients, more than 360 patients were treated for more than 48 weeks, and more than 80 patients were treated for more than 72 weeks.
Security data was unmasked for the DMC, but remains masked as far as the company is concerned. The DMC recommends the continuation of the NATiV3 clinical trial without modification to the current trial protocol. This positive recommendation confirms the good safety and tolerance profile of lanifibranor…
The final results of phase III are expected in 2025, underlines Portzamparc. “The DMC conclusions are encouraging for the safety and tolerability of lanifibranor.” Enough to keep the purchase on file…
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