DAIX, France--(BUSINESS WIRE)--Regulatory News:
Inventiva (Paris:IVA), a biopharmaceutical company developing innovative therapies, particularly to treat fibrosis, today announced an abstract entitled “PAN-PPAR Agonist IVA337 is Effective in the Prevention of Experimental Lung Fibrosis and Pulmonary Hypertension” has been selected among the best papers in the upcoming 15th International Workshop on Scleroderma Research being held August 5-9, 2017 at the University of Pittsburgh in Pittsburgh, PA. The 4-day biennial research meeting is centered on translational medicine related to systemic sclerosis (SSc).
“The paper highlights new data, which confirm the wide anti-fibrotic activity of IVA337, especially in the organs of patients affected by SSc,” said Professor Yannick Allanore, Principal Investigator and President of the European Scleroderma Trials and Research group. “The preservation of pulmonary activity is impressive and could indicate that IVA337 could meet a high unmet medical need in SSc patients.”
“We are very pleased to have been selected among the best papers being presented during this international systemic sclerosis congress,” said Pierre Broqua, Ph.D., Chief Scientific Officer and Co-Founder of Inventiva. “The congress draws interest from leaders in translational medicine and we are proud to see the high level of interest in the activity of IVA337 among this elite group.”
The new data generated show that IVA337 induces a marked protection from the development of lung fibrosis with restoration of respiratory capacity and inhibits pulmonary arteries remodeling with positive impact on pulmonary artery pressure. This large spectrum of activity demonstrates in addition to the previously positive effects demonstrated on skin fibrosis, the therapeutic potential of IVA337 on cardiorespiratory involvements in SSc patients.
For more information on the 15th International Workshop on Scleroderma Research, refer to https://sscworkshop.wordpress.com/about/
Systemic sclerosis is a rare and complex fibrotic disease. Due to the progressive failure of different organs, systemic sclerosis is a severe disease with a high mortality rate. Once patients are diagnosed with systemic sclerosis, generally between the ages of 40 and 50, the median survival period is of 11 years. Close to 170,000 people suffer from systemic sclerosis, with women outnumbering men by a ratio of more than five to one1.
Deeper study of this skin fibrosis has led to its classification into two sub-categories, respectively called limited cutaneous systemic sclerosis and diffuse cutaneous systemic sclerosis. The latter is more serious and is targeted in the Inventiva’s FASST Phase 2b trial which is enrolling up to a total of 132 patients at 50+ sites across Europe.
To date, only symptomatic drugs with limited therapeutic effects are available in order to attenuate the consequences of fibrosis progression. However, they do not prevent, delay or reverse the disease’s devastating process. IVA337 could offer a curative treatment for SSc patients by acting on several components of fibrosis and on several organs.
About IVA337 and FASST Phase 2b study
IVA337 is a new chemical entity that activates the three PPAR (peroxisome proliferator-activated receptor) isoforms. The product has demonstrated good tolerability, safety and efficacy in Phase I and Phase IIa studies, in approximately 100 healthy volunteers and 60 type 2 diabetic patients. IVA337 has received orphan status designation from EMA and FDA in SSc and a Phase IIb FASST trial validated by EMA is ongoing in this indication.
FASST is a one-year randomized double-blind study designed to enroll up to a total of 132 patients at 50+ sites across Europe. Patients are being administered one of the two doses of IVA337 or placebo. The study protocol, approved by the European Medicines Agency (EMA), has been designed to demonstrate the beneficial effect of IVA337 on progression of SSc. The primary endpoint is a measure of the change in the modified Rodnan skin score, a measure of disease progression accepted by both FDA and the EMA. Inclusion criteria are based on a MRSS (Modified Rodnan Skin Score) between 10 and 25, and diffuse systemic sclerosis diagnosed from less than 3 years. Patients are permitted to continue with their ongoing treatments, including immunosuppressive therapies.
About Inventiva: www.inventivapharma.com
Inventiva is a biopharmaceutical company specialized in the development of drugs interacting with nuclear receptors, transcription factors and epigenetic modulators. Inventiva’s research engine opens up novel breakthrough therapies against fibrotic diseases, cancers and orphan diseases with substantial unmet medical needs.
IVA337, its lead product, is an anti-fibrotic treatment with a strong action mechanism permitting the activation of all 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 in parallel, a second clinical product, odiparcil, which is a treatment for three different forms of mucopolysaccharidosis: MPS I or Hurler/Scheie syndromes, MPS II or Hunter syndrome and MPS VI also known as Maroteaux-Lamy syndrome. Inventiva has a preclinical stage oncology portfolio.
Inventiva benefits from partnerships with world-leading research entities such as the Institut Curie. Two strategic commercial partnerships, one of which is at clinical stage, have also been developed with AbbVie and Boehringer Ingelheim, making Inventiva eligible for preclinical, clinical, regulatory and commercial milestone payments, in addition to royalties on the products resulting from the partnerships.
Inventiva employs over 100 highly qualified employees and owns state-of-the-art 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.
Important Notice:
Some of the statements contained in this document are not historical facts but rather are statements of future expectations and other forward-looking statements that are based on management's beliefs. These statements reflect such views and assumptions prevailing as of the date of the statements and involve known and unknown risks and uncertainties that could cause future results, performance or future events to differ materially from those expressed or implied in such statements.
Please refer to the « Document de référence » filed with the Autorité des Marchés Financiers on April 26, 2017 under n° R.17-025 for additional information in relation to such factors, risks and uncertainties.
Inventiva has no intention and is under no obligation to update or review the forward-looking statements referred to above. Consequently Inventiva accepts no liability for any consequences arising from the use of any of the above statements.
1 Journal of Rheumatology, 2013