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
Dijon, 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.
Systemic sclerosis (SSc), or scleroderma is a connective tissue disease of autoimmune origin. It is a life-threatening orphan disease with severe physical and psychosocial consequences. Among case-specific connective tissue diseases, SSc is considered to have the highest frequency of mortality. Due to its severity, SSc presents a tremendous medical challenge in terms of prognosis and the health burden. There is currently no cure for this debilitating disease.
About Orphan Drug Designation
Orphan Drug Designation by the European Commission provides regulatory and financial incentives for companies to develop and market therapies that treat a life-threatening or chronically debilitating condition affecting no more than five in 10,000 persons in the European Union (EU) and where no satisfactory treatment is available.
In addition to a 10-year period of marketing exclusivity in the EU after product approval, Orphan Drug Designation provides incentives for companies seeking protocol assistance from the EMA during the product development phase and direct access to centralized marketing authorization.
Inventiva is a drug discovery company that focuses on therapeutic approaches involving transcription factors and epigenetic targets (particularly the HKMT family) to discover innovative treatments for cancer, fibrosis, immuno-inflammatory diseases and Parkinson’s disease.
The company’s business strategy is to engage in proprietary research programs and secure drug discovery partnerships with pharmaceutical groups. It also offers a full range of research services. These draw on its extensive technology platform, a proprietary library of 240,000 compounds and a fibrosis platform. Inventiva also has expertise in nuclear receptors, transcription factors and epigenetic modulation.
Over 100 employees are based at its research center in Daix, near Dijon, France.