J&J returns NASH med back to Arrowhead's quiver with hep B still in limbo

Arrowhead Pharmaceuticals' hepatitis B program may have been left in limbo after Fierce Pharma revealed that Johnson & Johnson is shaking up its infectious disease R&D group, but last week the company told investors it was at least confident its nonalcoholic steatohepatitis (NASH) collab with the Big Pharma was safe. Now, it appears J&J has even turned its back on that asset in another unexpected pipeline decision.

“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,” the biotech's CEO Christopher Anzalone, Ph.D., said in a release Wednesday morning. 

The candidate in question, dubbed ARO-PNPLA3, is in at least two phase 1 trials in patients with the fatty liver disease. One of these is a Japanese trial with an expected primary completion date listed on ClinicalTrials.gov for this week. However, the study, which was expected to sign up 18 patients, is listed as still recruiting. Another larger U.S.-based trial is also still recruiting. 

Arrowhead had not responded to Fierce for comment at time of publication.

The news comes just a week after the biotech's top brass reassured investors that the NASH asset was safe despite the industry being caught blindsided by the major pipeline changes at J&J's pharmaceutical arm Janssen, which left an uncertain path for the two companies' hepatitis B collaboration. 

On the February 6 earnings call, Arrowhead’s James Hamilton, M.D., chief of discovery and translational medicine, affirmed that Janssen’s wavering on the hepatitis B program had no implications on the NASH asset, saying that the two were in different divisions. News of the hepatitis B update came after Fierce Pharma reported that Janssen was winding down all hepatitis B and D work amid an overhaul of its infectious disease unit. 

The sudden change of plans underscores how quickly seismic shifts are taking place at Janssen. And it comes as J&J has tapped a new leader to head up its pharmaceutical R&D in the form of Sanofi's John Reed.

News of Janssen's decision is the latest bucket of cold water poured on the company's $3.7 billion October 2018 licensing and collaboration agreement with Arrowhead, which included $250 million in upfront cash and equity from J&J. A whopping $3.5 billion was also available in biobucks. In exchange, Arrowhead handed over rights to its hepatitis B program in addition to three other targets of Janssen's choosing that Arrowhead would aim its RNA interference platform toward. 

In reference to one of the phase 1 trials underway for ARO-PNPLA3, Arrowhead said in today's release that interim data showed that the med was safe and produced up to a 40% average reduction in liver fat among patients homozygous for a specific gene associated with disease development. It’s unclear which of the trials Arrowhead has referred to. 

While Arrowhead regroups to plan a path forward for the NASH product—and potentially the hepatitis B program—the biotech said in today's release that it’s still chugging ahead with phase 2 design plans. The company will also “assess options” for communicating full phase 1 results, it added.