Inventiva receives another positive opinion on orphan drug designation in the European Union for IVA337 – for Idiopathic Pulmonary Fibrosis
December 02, 2014
This follows an earlier positive opinion for IVA337 in October regarding the treatment of Systemic Sclerosis (SSc)
Dijon, France, December 2, 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 for the treatment of Idiopathic Pulmonary Fibrosis (IPF).
”After Systemic Sclerosis, Idiopathic Pulmonary Fibrosis is the second indication for which EMA granted IVA337 a positive opinion on orphan drug designation. It clearly indicates the potential our product IVA337 could have to treat fibrosis in various organs,” said Frédéric Cren, CEO and co-founder of Inventiva.
IPF is a chronic, progressive and fatal lung disease with no known cause. It is characterised by progressive dyspnoea and irreversible loss of lung function. The clinical course of the disease is variable and unpredictable with a uniformly poor prognosis.
“The medical need in IPF is tremendous and we believe IVA337 offers additional benefits when compared to current treatments. It has real potential,” said Pierre Broqua, chief scientific officer and co- founder of Inventiva. “Our clinical candidate mechanism of action clearly acts on various fibrotic pathways to deliver a unique therapeutic approach. The studies we have already performed with IVA337 in other indications allow us to quickly envisage a proof of concept study in IPF.”
IVA337 is a patent protected NCE (New Chemical Entity) that has previously demonstrated good tolerability, safety and efficacy in phase I and II studies in an unrelated indication. IVA337 has been investigated in several preclinical models of fibrotic disorders (lung, skin and liver).
In October 2014 IVA337 received a positive opinion on orphan drug designation as a treatment for Systemic Sclerosis (SSc). Inventiva is currently planning to start a phase IIa SSc clinical study in 2015.
IPF is associated with a number of co-morbidities, including pulmonary hypertension, COPD, lung cancer, coronary artery disease, diastolic dysfunction, gastro-oesophageal reflux disease, sleep disorders and psychiatric disturbances. The ultimate pattern is deterioration, with an estimated median survival of 2-3 years. The estimated prevalence in Europe is not more than 3 patients per 10,000.
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.
Lanifibranor, its lead product, is an anti-fibrotic treatment acting on the three alpha, gamma and delta PPARs (peroxisome proliferator-activated receptors), which play key roles in controlling the fibrotic process. Its anti-fibrotic action targets two initial indications with substantial unmet medical need: NASH, a severe and increasingly prevalent liver disease already affecting over 30 million people in the United States, and systemic sclerosis, a disease with a very high mortality rate and for which there is no approved treatment to date.
Inventiva is also developing a second clinical program with odiparcil (IVA 336) for the treatment of patients with mucopolysaccaridosis type VI (or Maroteaux-Lamy syndrome), a rare and severe gene disease affecting children. Odiparcil has also the potential to address other MPS types, characterized by the accumulation of chondroitin or dermatan sulfate (MPS I or Hurler/Sheie syndrome, MPS II or Hunter syndrome, MPS IVa or Morquio syndrome and MPS VII or Sly syndrome). Inventiva is also developing a portfolio of early research projects in the field of oncology.
Inventiva benefits from partnerships with world-leading research entities such as the Institut Curie in the field of oncology. Two strategic partnerships have also been established with world-class major pharmaceutical companies AbbVie and Boehringer Ingelheim in the fields of autoimmune diseases (specifically in psoriasis) and fibrosis respectively. These partnerships provide milestone payments to Inventiva upon the achievement of pre-clinical, clinical, regulatory and commercial milestones, in addition to royalties on the products resulting from the partnerships.
Inventiva employs over 100 employees and owns R&D facilities near Dijon, acquired from the international pharmaceutical group Abbott. The Company owns, a proprietary chemical library of over 240,000 molecules as well as integrated biology, chemistry, ADME and pharmacology platforms.
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