Inventiva has paused enrolling new patients into a phase 3 trial of its lead liver disease drug after one participant experienced raised enzyme levels.
The French biotech had been testing lanifibranor, a pan-PPAR agonist, in the late-stage NATiV3 study in patients with metabolic-associated steatohepatitis (MASH) and liver fibrosis.
More than 900 patients have been randomized in the study to date, one of whom experienced an adverse event of elevated levels of liver enzymes called aminotransferases, Inventiva explained in its full-year 2023 earnings report yesterday. The patient has been asymptomatic, and their blood tests are improving, the biotech said. Lab tests have since suggested that the individual may have autoimmune hepatitis, according to the company.
The event marks the first serious adverse reaction reported in any clinical trial of lanifibranor to date, Inventiva pointed out. The trial’s data monitoring committee has reviewed the adverse reaction report “in conjunction with other milder cases of elevation of aminotransferases among trial participants,” the company said.
The committee recommended that the study can continue if patients receive liver monitoring every six weeks and if new patients diagnosed with or with a predisposition to autoimmune liver or thyroid disease are excluded from the trial. As a result, the biotech has moved to temporarily suspend screening and randomizing any new patients into the study while the criteria are put in place.
“All our teams are working diligently, and we are confident that recruitment will resume in around four to six weeks' time,” CEO Frédéric Cren said in the release.
Inventiva had been on schedule to complete patient screening in the trial by the end of March but said the pause means the first visit of the final patient enrolled may occur later in the first half of the year.
The biotech had already revised plans for NATiV3 a year ago following feedback from the FDA that was designed to ease the pathway to approval for MASH—previously known as nonalcoholic steatohepatitis.
The company entered 2024 with cash and equivalents of 26.9 million euros ($28.9 million). This is a drop on the 86.7 million euros ($93.3 million) that Inventiva had to hand a year earlier, which the biotech attributed to costs from NATiV3 as well as a phase 2 study of lanifibranor in combination with Boehringer Ingelheim’s Jardiance in MASH and Type 2 diabetes that is due to read out in the first quarter of this year.
Along with a 25 million euro ($26.9 million) loan from the European Investment Bank, Inventiva said it expects to have enough cash to fund operations until around July.
Raised aminotransferases have blown numerous other biotechs off course in recent years, including forcing Centessa to drop two candidates in 2022 and leading Surrozen to cull a inflammatory bowel disease treatment last month.
Inventiva’s shares were down 16% in premarket trading Friday, at $3.30 compared to a Thursday closing price on the Nasdaq of $3.94.