Investigators at the University of Birmingham in the U.K. have published the results of a small but intriguing study that has highlighted the potential of Novo Nordisk's ($NVO) blockbuster diabetes drug Victoza (liraglutide) for NASH, an increasingly common liver disease.
Reporting in The Lancet, the researchers noted that they had recruited 52 patients with fatty liver disease and then evenly divided them between a placebo arm and a drug arm using liraglutide. Nine of the 23 drug arm patients who underwent a liver biopsy had their cases resolved, compared to two of 22 patients in the placebo arm. That achieved the goal of statistical significance, though Novo is acutely aware that this effect would have to be demonstrated in a much, much larger study before the pharma giant could even begin discussing an added approval with regulators.
The research team initially discussed the results of this study back in the spring. Victoza is approved for diabetes as well as obesity after demonstrating an ability to reduce weight among a broad range of diabetics.
"Most adverse events were grade 1 (mild) to grade 2 (moderate) in severity, transient, and similar in the two treatment groups for all organ classes and symptoms, with the exception of gastrointestinal disorders in 21 (81%) of 23 patients in the liraglutide group and 17 (65%) of 22 patients in the placebo group, which included diarrhea (ten [38%] patients in the liraglutide group vs five [19%] in the placebo group), constipation (seven [27%] vs none), and loss of appetite (eight [31%] vs two [8%])," the researchers reported in The Lancet.
"Because there are no licensed treatments available for non-alcoholic fatty liver disease, there is a large unmet clinical need," said lead investigator Philip Newsome. "It is becoming ever more important that we find a treatment as the occurrence of fatty liver disease continues to grow--hand in hand with the problem of obesity. This study provides confidence in the further exploration of this class of drugs in NASH."
There may not be an approved therapy, but there are a number of contenders in the clinic. NASH, which raises the risk of liver failure, afflicts about a quarter of the population in the U.S. and the U.K.
- here's the release
- here's the study in The Lancet