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

Airtel and Tata Group team-up to compete Jio’s 5G technology
Airtel and Tata Group team-up to compete Jio’s 5G technology
By Mateen Dalal

Bharti Airtel and Tata Group have entered into a strategic partnership to challenge Jio's ‘made-in-India’ 5G technology. The two companies are focusing on deploying 5G radio and core solutions, based on Open-RAN, which Airtel has...

NSW offers $480Mn EV package, waives stamp duty on EVs
NSW offers $480Mn EV package, waives stamp duty on EVs
By Mateen Dalal

In a bid to achieve net-zero emissions by 2050, the Government of New South Wales has committed to invest USD 480 million in a recent budget to encourage the adoption of electric vehicles, including limited USD 3,000 rebates along with removal of sta...

PwC announces ‘New Equation’ strategy to create 100,000 jobs
PwC announces ‘New Equation’ strategy to create 100,000 jobs
By Mateen Dalal

U.K based-PricewaterhouseCoopers or PwC has announced a new global strategy-The New Equation, which will see the company spend nearly USD 12 billion over a span of five years to create nearly 100,000 job roles across 155 of its territory firms in reg...