IVA337 is an anti-fibrotic drug with a novel mechanism of action that activates all three alpha, gamma, and delta PPARs (peroxisome proliferator-activated receptors). These receptors play key roles in controlling the fibrotic process.1
The new chemical entity, being developed by Inventiva, is the company’s lead product to treat scleroderma.
Clinical trials involving IVA337
IVA337 showed good tolerability, safety, and efficacy in Phase 1 and 2a studies in healthy volunteers and diabetic participants.2 Its anti-fibrotic efficacy was demonstrated in in vitro and in vivo preclinical studies, with IVA337 inducing the regression of pre-existing fibrotic damage in the liver and in the skin, and preventing further development of fibrosis.
A Phase 2b proof-of-concept study, called is FASST (NCT02503644), is currently recruiting about 130 patients with diffuse cutaneous scleroderma. This study’s objective is to compare two doses of IVA337, 400 mg and 600 mg, against placebo over 48 weeks of treatment. During this time, assessments will be made to monitor both the efficacy and safety of the treatment, with a primary goal — change in measures of skin thickness — determined by the Modified Rodnan Skin Score (MRSS).3
The trial is expected to conclude in late 2017 and is taking place at various sites in seven European countries.
More about IVA337 for scleroderma
IVA337 received orphan status designation from both the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) for scleroderma, and its clinical development plan has been validated by the EMA.2
By acting on several fibrosis components and on several organs, IVA337 may offer a curative treatment for people with scleroderma, the company reports on its website.
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