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news.The European Medicines Agency's (EMA) Committee for Orphan Medicinal Products (COMP) has given a positive opinion on the designation of French drug discovery firm Inventiva's lead clinical candidate IVA337 as an orphan medicinal product to treat Systemic Sclerosis (SSc).
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SSc or scleroderma is a connective tissue disease of autoimmune origin with severe physical and psychosocial consequences.
IVA337 is a patent protected new chemical entity (NCE) that has previously showed good tolerability, safety and efficacy in Phase I and II trials in an unrelated indication.
The drug candidate has been evaluated in several preclinical models of fibrotic disorders and reverses established skin fibrosis in curative settings.
Inventiva chief scientific officer and co-founder Pierre Broqua said: "Our clinical candidate acts on several components of fibrosis to deliver a unique therapeutic approach to SSc patients."
Inventiva’s science advisor Jean-Louis Junien said: "This favorable opinion reflects the quality of Inventiva’s drug discovery programs and strong capabilities in fibrosis research.
"We are looking forward to entering into a phase 2a proof of concept clinical trial in 2015."
The European orphan drug designation (ODD) offers a ten-year period of marketing exclusivity in the EU after product approval, as well as provides incentives for companies seeking protocol assistance from the EMA during the product development phase and direct access to centralized marketing authorization.