Clinical Trials

Date: 2017-04-10

Type of information: update on patient enrollment

phase: 2

Announcement: update on patient enrollment

Company: Inventiva Pharma (France)

Product: IVA337 - lanifibranor - 1-(6-benzothiazolylsulfonyl)-5-chloro-1H-indole-2-butanoic acid)

Action mechanism:

PPAR modulator. This compound is a peroxisome proliferator activated receptors (PPAR) modulator. It has demonstrated anti-fibrotic properties in several tissues alongside good clinical tolerance. Its unique mechanism of action goes through the activation of all three alpha, gamma and delta PPARs to slow, halt or reverse the progression of fibrosis.
IVA337 has received orphan drug status for the treatment of systemic sclerosis in Europe and the United States.

Disease: systemic sclerosis

Therapeutic area: Rare diseases - Autoimmune diseases

Country: France, Germany, Italy, Spain, Switzerland,UK

Trial details:

The randomized, double-blind, placebo-controlled mutlicentre proof-of-concept study is designed to compare IVA337 at two dose levels with a placebo control treatment. Patients will be unaware of the treatment they are receiving and will be randomized to one of three treatment arms , either IVA337 400mg bid, IVA337 600mg bid or placebo bid. They will receive drug for 48 weeks and during that time assessments will be made to monitor both the efficacy and safety of the treatment. (NCT02503644)

Latest news:

• On April 10, 2017, Inventiva announced that it has enrolled the 100th patient into the Phase IIb FASST trial of IVA337 for the treatment of systemic sclerosis (SSc), by enrollingl. The trial, which began in December 2015, is now 75% enrolled. Inventiva is currently on track to complete enrollment in the second half of 2017, with topline results expected to be available in the second half of 2018.
• On January 28, 2016, Inventiva announced the enrolment of the first patients in its international Phase IIb FASST2 trial of IVA337, in the treatment of systemic sclerosis. The trial will include a total of 135 patients in 8 European countries, who will be given a placebo or one of the two doses of IVA337 being tested. The study protocol, which was endorsed by the European Medicines Agency, aims to demonstrate the positive impact of IVA337 on disease progression in patients who have contracted the most severe form of systemic sclerosis.
The anti-fibrotic effects of IVA337 on the skin, lungs, kidneys and liver open up a pathway for the treatment of numerous fibrotic diseases. Inventiva therefore decided to pursue the development of IVA337 in the treatment of two fibrotic diseases with very high unmet medical needs: NASH and systemic sclerosis. Inventiva intends to launch another phase 2b trial for the treatment of NASH.