The FASST clinical trial failed to meet its primary endpoint of a mean absolute change from baseline to week 48

The French clinical-stage biopharmaceutical firm Inventiva has reportedly declared the results from the ‘For A Systemic Sclerosis Treatment’ (FASST) clinical trial assessing lanifibranor for the treatment of diffuse cutaneous systemic sclerosis (dcSSc). As per trusted sources, the FASST clinical trial failed to meet its primary endpoint of a mean absolute change from baseline to week 48.

Reportedly, the FASST clinical trial included 145 patients suffering from the initial phase of dcSSc. These patients received lanifibranor in either two dosages of 600mg each day or two dosages of 400mg each day over a period of 48 weeks. Sources familiar with the matter claim that the dosages were in addition to the existing standard of care and included immunosuppressive therapy in most cases. For the record, the FASST clinical trial is a placebo-controlled, randomized, double-blind, one-year Phase IIb study.

Co-principal investigator of the FASST clinical trial and professor of rheumatology at the Hôpital Cochin in Paris, Yannick Allanore was reportedly quoted saying that the trail characterizes the first study in dcSSc with a stratified background on immunosuppressive therapy. Allanore further added that the presence of background therapy created a strong placebo effect and restricted the number of patients making progress in dcSSc.

According to a press release issued by Inventiva, over the course of the trial, the average mRSS declined in active and placebo arms with only four patients reporting to have observed increase in mRSS scores.

Co-principal investigator of the FASST clinical trial and professor at the University College of London, Christopher Denton reportedly commented that the team regrets the outcome of the study. However, lanifibranor’s favorable safety profile observed in the trial and the well-being of lanifibranor patients expressed in the global assessment has been a gratifying experience for the team.