Inventiva’s Phase IIb FASST Trial In Systemic Sclerosis With Lanifibranor Completes Enrollment
► Enrollment complete – 145 patients randomized
► A total of 47 clinical sites in 10 countries actively recruited patients
► Headline results expected in early 2019
Daix (France), October 17, 2017 – Inventiva, a biopharmaceutical company developing innovative breakthrough therapies, particularly for the treatment of fibrotic diseases, today announced that it has completed the enrollment of its Phase IIb FASST (For A Systemic Sclerosis Treatment) trial in Systemic Sclerosis (SSc) with lanifibranor, formerly known as IVA337. FASST is progressing well and investigators have enrolled and randomized 145 patients. Headline results are expected in early 2019.
“We are pleased to have achieved this important enrollment milestone in the development of lanifibranor for the treatment of systemic sclerosis,”
said Dr. Jean-Louis Abitbol, Chief Medical Officer and Head of Development of Inventiva. “The decision to open new countries and sites has resulted in a larger number of patients recruited and a slightly longer than anticipated recruitment period. We are very grateful to the patients and our network of investigators for the achievement of this important milestone.”
“The FASST trial protocol meets EMA and FDA approval standards. Therefore, if the results of the FASST Phase IIb are positive, we are very confident that lanifibranor will be successful in the pivotal Phase III,” added Professor Yannick Allanore, Professor of Rheumatology at Hôpital Cochin in Paris and co-Principal Investigator of the FASST trial with Professor Chris Denton, Professor of Experimental Rheumatology at University College London.
“Systemic sclerosis is a serious disease with a high unmet medical need. Current treatments mainly manage complications or provide symptomatic relief whereas lanifibranor has the potential to modify the course of the disease, thus representing a significant step forward for patients. We are looking forward to the result of this trial and to lanifibranor further development,” said Dominique Godard, President of the French SSc Association.
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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.
Lanifibranor, 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 syndrome, 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 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.