Positive opinion on orphan drug designation

Nov 9, 2014 | News, Scleroderma, Treatment

Inventiva receives positive opinion on orphan drug designation in the European Union for IVA337 – a treatment for Systemic Sclerosis (SSc)

With few approved drugs available in SSc, this approach could significantly improve the treatment options in the future.

inventivaDijon, France, November 3, 2014 – Inventiva, a drug discovery company that focuses on therapeutic approaches involving transcription factors and epigenetic targets, today announces that the Committee for Orphan Medicinal Products (COMP) at the European Medicines Agency (EMA) has given a positive opinion on the designation of IVA337 as an orphan medicinal product.

IVA337 is Inventiva’s lead clinical candidate for the treatment of Systemic Sclerosis (SSc).

This positive COMP opinion is a key milestone in our clinical development plan for IVA337,” said Pierre Broqua, chief scientific officer and co-founder of Inventiva. “Our clinical candidate acts on several components of fibrosis to deliver a unique therapeutic approach to SSc patients.”

“This favorable opinion reflects the quality of Inventiva’s drug discovery programs and strong capabilities in fibrosis research,” said Jean-Louis Junien, Inventiva’s science advisor. “We are looking forward to entering into a phase 2a proof of concept clinical trial in 2015.”

“IVA337 has strong potential for becoming a breakthrough therapeutic option for SSc patients,” said Professor Yannick Allanore, professor of rheumatology, University Paris Descartes and INSERM U1016, who is collaborating with Inventiva on this exciting project.

IVA337 is a patent protected NCE (New Chemical Entity) that has previously demonstrated good tolerability, safety and efficacy in phase 1 and 2 studies in an unrelated indication. IVA337 has been investigated in several preclinical models of fibrotic disorders and reverses established skin fibrosis in curative settings.


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