Inventiva Pharma’s lead product, IVA337, recently received a positive review by The European Medicines Agency’s (EMA) Committee for Orphan Medicinal Products (COMP) to treat Systemic Sclerosis. The news is a step in the right direction for patients in Europe suffering from the disease, and is also yet another positive sign of worldwide progress in advancing new therapies for Scleroderma.
The “orphan drug” designation is granted to the development of therapies for diagnosis, prevention, or treatment of rare diseases that are life-threatening or extremely serious. The status allows drug developers to take advantage of fast-tracked approval from drug administrations and gain favorable tax benefits and market exclusivity for a period of time should their drug be approved.
Scleroderma, also known as systemic sclerosis, is an autoimmune disease characterized by skin thickening, a process known as fibrosis. While in some types this hardening is confined to skin in head, face, and feet, in more severe cases, it affects internal organs such as kidneys, heart, lungs and the intestines. The disease is currently without treatment and is associated with high mortality rates.
IVA337 was previously tested in two clinical trials, Phase I and II, where it showed positive tolerability. In preclinical models of fibrotic disorders, the drug was capable of producing a reversed skin fibrotic pattern.
Inventiva chief scientific officer and co-founder Pierre Broqua commented, “Our clinical candidate acts on several components of fibrosis to deliver a unique therapeutic approach to SSc patients.”
Jean-Louis Junien, Inventiva’s science advisor, added, “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.”
Professor Yannick Allanore, professor of rheumatology, University Paris Descartes and a collaborator of Inventiva commented, “IVA337 has a strong potential for becoming a breakthrough therapeutic option for SSc patients.”