another fibrotic failure19 Feb 2019 13:11
yet another failure in an anti-fibrotic linked to NASH, etc. 'Good' news for us at the margin..... Patience....Patience...
France’s Inventiva (Euronext: $IVA) has suffered its first big setback following its public listing in 2017. The company’s lead experimental drug, lanifibranor, failed a mid-stage trial in patients with a form of systemic sclerosis (SSc) — a rare, chronic life-threatening disorder in which the immune system attacks its own organs and is characterized by a buildup of scar tissue — prompting the Daix-based drug developer to abandon the program for the indication.
The Phase IIb trial evaluated two doses of lanifibranor (800 mg, 1200 mg) against a placebo in 145 patients with diffuse cutaneous systemic sclerosis, which account for roughly 35% of the SSc population. Patients were given lanifibranor in either two doses of 400mg per day or two doses of 600mg per day over 48 weeks in addition to standard of care, which typically included immunosuppressive therapy.
Compared to the placebo, neither dose of the drug induced a statistically significant change in the modified Rodnan Skin Score — a scale measuring the evolution of skin fibrosis, which is correlated with internal scarring — missing the main goal of the study. None of the secondary endpoints, including changes in pulmonary function measured via forced vital capacity and overall progression of the disease, were met, Inventiva said on Monday.......