Inventiva declares results of Phase IIb clinical trial of lanifibranor
Category: #health  By Mateen Dalal  Date: 2019-02-19
  • share
  • Twitter
  • Facebook
  • LinkedIn

Inventiva declares results of Phase IIb clinical trial of lanifibranor

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.

  • share
  • Twitter
  • Facebook
  • LinkedIn


About Author

Mateen Dalal    

Mateen Dalal

Mateen has completed his Bachelor’s degree in electronics and telecommunication engineering, post which he lent his proficiency to the industry, working as a quality and test engineer. Drawn intricately toward the field of content creation however, Mateen soon switc...

Read More

More News By Mateen Dalal

Deciphera to present data from DCC-3014 trial at CTOS annual meet
Deciphera to present data from DCC-3014 trial at CTOS annual meet
By Mateen Dalal

The ongoing clinical trial of DCC-3014 have shown preliminary anti-tumor activity.    DCC-3014 validates emerging tolerability profile with no Grade 3 or Higher TEAEs.   Encore presentation of data from the INVICTUS Pivotal Phase...

Roches risdiplam meets primary endpoint results in phase 3 trial
Roches risdiplam meets primary endpoint results in phase 3 trial
By Mateen Dalal

Spinal muscular atrophy (SMA) is a genetic neuromuscular condition, affecting approx. 1 in 6,000 babies born globally each year. Numerous healthcare companies throughout the world are putting their best foot forward to develop an effective ...

Disney+ all set for a March 2020 launch in the United Kingdom
Disney+ all set for a March 2020 launch in the United Kingdom
By Mateen Dalal

The entertainment behemoth is launching its much-awaited streaming platform.   Release of more than 300 movies is on the cards. Disney has finally asserted that new streaming service Disney+ will be rolled out soon in the U.K. Disney+ goes...