Gilead developed a non-alcoholic fatty hepatitis drug to complete the mid-stage trial

Gilead has new data to support its non-alcoholic fatty hepatitis (NASH) liver disease candidate GS-9674, which is considered one of the next big growth markets for the pharmaceutical industry. Phase 2 data presented by
at the Liver Conference showed that the Farniol X-recipient (FXR) agonist GS-9674 was a biomarker that reduced liver fat content and improved liver function compared to placebo, characterized by the accumulation of fat that can lead to fibrosis, cirrhosis, and liver transplantation in some patients.
In the non-alcoholic fatty hepatitis study, 39 percent of patients took a high dose of the drug once a day for 24 weeks, reducing liver fat by at least 30 percent, compared with 12.5 percent in the placebo group.
new data show Gilead's drug is working as expected, but analysts say the results don't look particularly strong compared to Intercept Pharma's Oculus acid, which is already on the market for primary bile cirrhosis (PBC) and stage 3 for patients with non-alcoholic fatty hepatitis cirrhosis.
GS-9674 is a non-bile acid FXR with fewer side effects than Oculus, especially itching. Isis accounted for 14 percent of the high-dose group, compared with 4 percent in the placebo group, but was still better than Oculus, which, according to the EMA, can cause itching or more in 60 percent of the subjects. According to some analysts, all eyes are now on Novarma's rival FXR agitant, known as tropifexor, which will be reported at a liver conference later and is unlikely to cause itching.
Gilead said it intended to continue developing the GS-9674, but the latest results take it one step closer to developing effective non-alcoholic fatty hepatitis treatments and entering the market, with some analysts predicting a potential value of up to $20 billion. The company said it believes the combination therapy will be key to a significant impact on non-alcoholic fatty hepatitis by combining GS-9674 with two other drug candidates, ASK1 inhibitors Selonsertib and ACC inhibitor GS-0976, for trial 2, which will announce results next year.
, however, it also faces stiff competition, with Novartis and Pfizer recently agreeing to join forces to develop a combination of non-alcoholic fatty hepatitis drugs. Novart is contributing to tropifexor - currently in Phase 2 - while Pfizer is incorporating ACC inhibitors (PF-05221304), DGAT2 inhibitors (PF-06865571) and KHK inhibitors (PF-06835919) into the alliance. All Pfizer drugs are in the early to mid-stage stages of development.
rare disease isAt the same time, Gilead reported stage 2 results from GS-9674 in another liver disease, a rare disease called sclerotic bile ductitis, which causes the network of pipes that the bile ducts drain from the liver to become inflamed and scarred over time.
, in this study, FXR agonists were associated with significant improvements in the liver biochemistry and bile siltation market (reduced bile flow) compared to placebos. (This web article)