Rare Disease Report

Phase 3b Trial of Potential Systemic Sclerosis Therapy Completes Enrollment

OCTOBER 17, 2017
Mathew Shanley
Biopharmaceutical company Inventiva announced today that it has completed enrollment for its Phase 3b FASST (For A Systemic Sclerosis Treatment) trial in Systemic Sclerosis (SSc).

145 patients with SSc were randomized for participation in the trial and enrolled at 47 clinical sites across 10 countries. Each will be dosed either with lanifibranor, formerly known as IVA337 or a placebo approved by the European Medicines Agency (EMA). Headline results are expected in early 2019.

SSC is a life-threatening multisystem autoimmune disorder in which there is increased fibroblast activity that results in irregular growth of connective tissue. The growth leads to vascular damage and fibrosis in the skin, gastrointestinal (GI) tract, heart, and lungs, among other internal organs. The condition has the potential to leave patients disfigured and disabled.

Patients are generally diagnosed with SSc between the ages of 40 and 50, and at present, thecondition affects approximately 170,000. Women currently outnumber men by a ratio of more than 5-to-1.

Lanifibranor is a next-generation panPPAR modulator, and the one-year, randomized, double-blind study is designed to measure its effect on disease progression. Change in Modified Rodnan Skin Score (MRSS), a measure of disease progression accepted by both the EMA and U.S. Food and Drug Administration (FDA) is the primary endpoint.

“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 in a press release. “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.”

Preclinical data of the prospective therapy also exhibit its potential to treat pulmonary arterial hypertension, which is often associated with SSc. Inventiva is also currently evaluating the safety and efficacy of lanifibranor in a Phase 2b clinical study in non-alcoholic steatohepatitis (NASH), and the company’s second clinical product, Odiparcil (formerly IVA336) is in development for 3 different forms of mucopolysaccharidosis (MPS).

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