Inventiva Discontinues Systemic Sclerosis Drug After Mid-Stage Flop

Shares of France-based Inventiva have plunged more than 45 percent after the company reported that its experimental treatment for a rare autoimmune disease failed to hit primary and secondary endpoints in a mid-stage trial. Inventiva said its FASST (For A Systemic Sclerosis Treatment) clinical trial evaluating lanifibranor for the treatment of patients with diffuse cutaneous systemic sclerosis failed to hit its primary endpoint compared to placebo. There was a decrease in the average modified Rodnan Skin Score (mRSS) observed in active and placebo arms with only four patients reporting to have increased in mRSS scores over the course of the trial, the company said. The trial also failed to hit its secondary endpoints, the company added.
Although those endpoints were not met, Inventiva said lanifibranor showed a favorable trend in patients' global assessment of disease activity, which indicates a perceived benefit in patients. The drug did have a favorable safety profile, the company said. Despite those positives, the company will discontinue lanifibranor's clinical development for the treatment of dcSSc in order to fully focus on the development of lanifibranor for the treatment of NASH. Full results of the trial will be presented on Feb. 27 when the company provides its full-year results.