A data safety monitoring board (DSMB) has recommended that Inventiva continue its Phase 2b clinical trial assessing lanifibranor (previously known as IVA337) for the treatment of diffuse cutaneous scleroderma, after reviewing data gathered in the study to date.
The trial, which is now fully enrolled with 145 patients, compares lanifibranor to a placebo. Researchers believe that the treatment has the potential to slow disease progression in people with scleroderma by controlling fibrosis development.
The DSMB reviewed information about adverse events and other safety data and found no reason to alter the study’s design, the company said in a press release.
The Phase 2 FAAST trial (NCT02503644) is currently underway at multiple sites across Europe. The study randomly assigned patients to one of two lanifibranor doses — 400 mg or 600 mg twice a day — or a placebo.
Patients are treated for 48 weeks and then monitored for an additional 12 weeks. Currently, 100 patients have gone through six months of treatment, including 54 who have completed the entire study period.
Researchers primarily assess disease progression by measuring changes in the Modified Rodnan Skin Score. But the study also explores if the treatment affects other areas, including lung and gastrointestinal symptoms, digital ulcers, and general health. It also explores the therapy’s safety.
Lanifibranor is a compound that activates three types of peroxisome proliferator-activated receptors, which play key roles in controlling the fibrotic process. While the trial is ongoing, Inventiva shared data on the therapy’s beneficial effects in experimental animals last year. The study showed that treatment prevented fibrosis in a range of organs typically affected in scleroderma patients.
U.S. and European regulators believe that lanifibranor has the potential to become a significant treatment option for scleroderma patients. Both the U.S. Food and Drug Administration and the European Medicines Agency have granted lanifibranor orphan drug status for the treatment of scleroderma. This designation provides Inventiva several advantages, including expert scientific advice on the design of trials, reduced costs, and commercial exclusivity.
Inventiva expects results from the FAAST trial to be available by early 2019.