Janssen hands NASH candidate back to Arrowhead

Feb. 16, 2023

Arrowhead Pharmaceuticals announced that Janssen Pharmaceuticals has handed back the rights to an experimental treatment for non-alcoholic steatohepatitis (NASH) — a type of liver disease for which there are currently no FDA approved drugs.

ARO-PNPLA3, formerly called JNJ-75220795, was part of a 2018 research collaboration and option agreement between Arrowhead and Janssen. Under the deal, Janssen obtained a worldwide license for Arrowhead’s experimental Hepatitis B drug and an option to collaborate on up to three new RNA interference (RNAi) drugs,  using Arrowhead's gene-silencing technology. The deal had a combined potential value of over $3.7 billion for Arrowhead.

Now, the California-based company has now regained control of one of the RNAi drugs from the deal  — ARO-PNPLA3 — currently in phase 1 trials. ARO-PNPLA3 is an investigational RNAi therapeutic developed using Arrowhead’s proprietary TRiMTM platform and designed to reduce liver expression of patatin-like phospholipase domain containing protein 3 (PNPLA3) as a potential treatment for patients with NASH.

"We understand that Janssen is undergoing a strategic R&D portfolio review and subsequently advised us of their decision to return full rights to this promising NASH candidate back to Arrowhead,” said Christopher Anzalone, Arrowhead’s president and CEO.

NASH is a subgroup of non-alcoholic fatty liver disease. Although there are many investigational drugs in clinical study, there are no drugs specifically approved for the treatment of NASH.