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NASH drugs come into focus as field awaits late-stage data

For drugmakers searching to find a treatment for non-alcoholic steatohepatitis, a chronic liver condition commonly known as NASH, questions still outnumber answers.

What's become clear, however, is that a therapeutic solution will require several complementary approaches, rather than a single cure-all drug.

While four companies — Intercept Pharmaceuticals, Gilead Sciences, Genfit and Allergan — have advanced experimental NASH treatments into Phase 3 testing, the field remains open.

"None of these drugs are so effective that it is clearly going to own the market," Raymond James analyst Steven Seedhouse said in an interview with BioPharma Dive. "There's room to improve on response rates and, because most of these drugs are pills, there's room to combine them."

At this year's Liver Meeting, which kicks off today in San Francisco and runs through Tuesday, NASH researchers and investors will get a closer look at a second wave of biotechs currently advancing earlier drug candidates through mid-stage studies. Results presented at the conference will help clarify the potential of those therapies and could serve as a catalyst for fresh dealmaking.

The 2018 edition of the Liver Meeting will also serve as a prelude to next year, when three of the four NASH front-runners are expected to read out late-stage data. Success by any could lead to the first approved therapy for the complex disease.

"I think everyone understands that it will either be monotherapy or combination therapy, and there will be room on the market for several different drugs," said Dean Hum, chief operating officer at Genfit, in an interview with BioPharma Dive.

In that respect, the emerging field of NASH therapies may differ from that of hepatitis C, dominated by one or two drugmakers with highly effective pills that essentially "cure" the viral liver disease.

That's a good thing for the handful of biotechs looking to prove the merit of their own NASH pipelines. At the liver meeting, attention will turn in particular to Madrigal Pharmaceuticals, Viking Therapeutics and Galmed Pharmaceuticals, along with several other companies. All will present varying levels of Phase 2 data that could inform the direction of the field.

Dealmaking in NASH has remained on the smaller side, with a steady drumbeat of licensing deals and research collaborations. But larger pharma companies have taken note of both the opportunity and the field's progress to date.

"I think there is good interest from big pharma, which was not the case when we started, when Intercept started," said Genfit's Hum.

Just recently, for example, Novartis partnered with Pfizer to study early-stage combinations of their respective NASH drugs.

Wall Street is hoping that interest yields sizable M&A, potentially as business development teams digest the results to come from over this weekend.

As pipelines mature, however, valuations for companies like Intercept and Madrigal have grown, making any prospective buyout more pricey.

https://www.biopharmadive.com/news/nash-drugs-come-into-focus-as-field-awaits-late-stage-data/541779/



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