Riding the wave of a phase 2 win, Inventiva is gearing up for its U.S. IPO. The French biotech filed to raise up to $90 million in its Nasdaq debut, which will push its lead program into a phase 3 NASH study and advance a treatment for a rare lysosomal storage disorder.
Inventiva reported on Tuesday that lanifibranor, its treatment for nonalcoholic steatohepatitis (NASH) beat placebo at improving inflammation, scarring and other measures in a phase 2 study. It will use the IPO proceeds to “complete preparations for and initiate a Phase III clinical trial” of lanifibranor, according to a securities filing.
The study tested two doses of lanifibranor against placebo in patients with NASH. After 24 weeks of treatment, nearly half of the patients taking the higher dose, 1200 mg daily, had at least a two-point reduction in their Steatosis Activity Fibrosis (SAF) score—a measure of fat buildup, liver inflammation and liver cell ballooning—without their scarring getting worse, compared to 27% in the placebo group. Inventiva plans to present the phase 2b findings at the annual meeting of the American Association for the Study of Liver Diseases this November.
Lanifibranor is a pan-PPAR agonist, meaning it activates three forms of PPAR: alpha, gamma and delta. The hope is targeting all three will spare the drug from the failures seen in PPAR agonists that hit just one or two forms of the receptor protein. Last November, Cymabay abandoned its PPAR-delta agonist seladelpar in NASH after patients showed signs of liver damage. And more recently, Genfit reported a phase 3 failure for elafibranor, which targets PPAR-alpha and PPAR-delta, as it did not beat placebo at improving NASH symptoms without making scarring worse.
The offering will also bankroll odiparcil, which it’s developing for mucopolysaccharidosis type VI, also called MPS VI or Maroteaux-Lamy syndrome, a rare genetic disorder in which patients make faulty versions of certain proteins, or don’t make those proteins at all. Because many different mutations in the ARSB gene can cause the disease, symptoms vary widely between patients. The only FDA-approved treatment for MPS VI is enzyme replacement therapy (ERT) with BioMarin’s Naglazyme; all other care focuses on managing symptoms.
With the funds, Inventiva will finish a phase 1b/2 study of odiparcil in children with MPS VI and start a phase 2a extension study in patients aged 16 and older, it said in the filing. It will also kick off a phase 3 trial of the drug, both on its own and in combination with enzyme replacement therapy, in adults and children with MPS VI. Beyond its two leading programs, the company will fund preclinical work, including a program targeting the Hippo signaling pathway in non-small cell lung cancer and mesothelioma.