Novartis punts Pliant-partnered NASH prospect amid pipeline prioritization pivot

Novartis is nixing a nonalcoholic steatohepatitis (NASH) candidate amid a narrowing of its therapeutic focus, walking away from a Pliant Therapeutics program it paid $50 million for back in 2019.

Over the past 10 months, Novartis has formed a new organizational structure focused on five core therapeutic segments: cardiovascular, hematology, solid tumors, immunology and neuroscience. While the Swiss drugmaker may pursue other therapeutic areas opportunistically, most of its R&D dollars will go into its core areas. NASH, once the subject of a big push by Novartis, is no longer a neat fit for its focus.

Pliant has paid the price for Novartis’ pipeline rethink. Late Thursday, the biotech revealed Novartis has decided to terminate its agreement “as part of its new strategy focusing on a limited number of therapeutic areas.”

The agreement covered PLN-1474, a small molecule selective inhibitor of integrin αvß1. Novartis paid $50 million upfront, and made an investment in Pliant, to secure rights to the then-preclinical prospect and candidates against up to three additional integrin research targets. Last year, Novartis paid another $4 million to license compounds associated with an integrin research target.

Walking away from PLN-1474 continues Novartis’ retreat from NASH. The Big Pharma licensed LLF580, an FGF21 stimulator, to Boston Pharmaceuticals in 2020, as well as dropping its FXR agonist tropifexor from the pipeline last year. The phase 1 candidate FIA586 is now the last Novartis NASH asset standing. But, with Pliant saying Novartis plans to “divest clinical NASH assets,” that prospect could also be on the way out. 

Novartis’ nixing of PLN-1474 comes weeks after CEO Vas Narasimhan, M.D., said he was “streamlining the pipeline” and told analysts to expect to see the company “exiting additional assets as we really try to prune out non-core areas.” The pruning is intended to allow Novartis to put all its “scientific firepower and ingenuity towards building out a deep set of pipeline assets” in its five core areas, Narasimhan said.

Pliant exits the deal having received $79 million from Novartis but without pocketing most of the $416 million in milestones covered by the deal. The biotech has added PLN-1474 back into its wholly owned pipeline—describing it as phase 2 ready—and expects to post phase 2 data on bexotegrast, its lead drug, in idiopathic pulmonary fibrosis and primary sclerosing cholangitis this year.