Novo's liraglutide works in diabetes and obesity. How about NASH?

Novo Nordisk Chief Science Officer Mads Krogsgaard

The commercial potential of NASH, a common liver disease with no approved treatments, has seemingly launched a thousand R&D ships around the industry. And Novo Nordisk ($NVO), emboldened by an investigator-sponsored study, might be sitting on an effective therapy for the pervasive ailment with liraglutide, a blockbuster already approved for diabetes and obesity.

In a small Phase II study presented at last month's International Liver Congress, liraglutide beat out placebo in treating NASH, or nonalcoholic steatohepatitis, after 48 weeks of treatment, using liver biopsy to confirm the results. The study, sponsored by the U.K.'s University of Birmingham, concluded that one daily dose of Novo's drug has the potential to ward off NASH's characteristic liver scarring, and researchers strongly recommended advancing the subcutaneous treatment into Phase III to see if the provise pans out.

And Novo is listening. The company told Reuters that the Birmingham data were "very interesting" and that its in-house researchers are looking into starting a NASH program of their own but are yet to make a final decision.

The prevalence of NASH and other fatty liver diseases in the developed world has galvanized a growing horde of drugmakers to pursue projects in the field. Leading the way is Intercept Pharmaceuticals ($ICPT), whose breakthrough-designated obeticholic acid is on its way into Phase III after posting some promising mid-stage efficacy data. French biotech Genfit is pressing into Phase III with its NASH drug despite a mid-stage failure, while Gilead Sciences ($GILD), Shire ($SHPG), Enanta Pharmaceuticals ($ENTA) and a host of other advance therapies of their own.

As for Novo, if liraglutide can come through in NASH, the Danish drugmaker could burnish what is already a blockbuster product. The drug, which mimics the protein GLP-1, is approved as Victoza to treat Type 2 diabetes and brings in more than $2 billion a year from that indication. In 2014, Novo won approval for a higher dose liraglutide to treat obesity, launching that drug under the name Saxenda earlier this year.

But the company isn't getting ahead of itself. The Birmingham study involved only 52 patients, and, as investigators noted, it's unclear how much of liraglutide's observed benefits in NASH is direct and how much is a result of the drug's effect on weight loss. As Reuters notes, Chief Science Officer Mads Krogsgaard Thomsen told a Danish newspaper that the study involved "a very small patient group, but I believe it is fair to say that we have been discussing this in management."

- read the Reuters story
- get more on the study

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