Gilead Sciences, Inc. (GILD – Free Report) announced encouraging data from a proof-of-concept study of experimental combination therapies for patients with advanced fibrosis due to nonalcoholic steatohepatitis (“NASH”). The data were presented at The International Liver Congress 2018 in Paris.
Apoptosis signal-regulating kinase 1 (ASK1) inhibitor selonsertib was combined with either the Acetyl-CoA carboxylase (“ACC”) inhibitor GS-0976 or the selective, non-steroidal Farnesoid X receptor (“FXR”) agonist GS-9674 as therapies.
Patients diagnosed with NASH and liver fibrosis stages F2 to F3 based on biopsy, or by magnetic resonance elastography (“MRE”) and MRI proton density fat fraction (MRI-PDFF) enrolled in the study. They were treated with either selonsertib 18 mg plus GS-0976 20 mg (n=20), selonsertib 18 mg plus GS-9674 30 mg (n=20), or each monotherapy (n=10 per group) once daily for 12 weeks.
Post treatment the most notable change that were observed was the decrease in liver fat content (measured by MRI-PDFF), which occurred in regimens containing GS-0976. The results also showed improvements in liver biochemistry and/or markers of fibrosis across both combination arms of the study compared to baseline. Moreover, patients treated with selonsertib plus GS-0976, kinetic labeling showed reduction in the fractional synthesis rate of lumican, a marker of fibrogenesis.
Hence, the favorable results suggest that combination therapy with selonsertib and either GS-0976 or GS-9674 can be evaluated further in patients with NASH and F3 and F4 fibrosis.
Gilead also announced completion of enrolment in the phase III trials, STELLAR selonsertib. Gilead’s NASH pipeline include selonsertib, GS-9674 and GS-0976, alone and in combination
Concurrently, Gilead presented data from a pre-clinical study of another combination treatment approach for NASH, evaluating GS-9674 and GS-0976 together and as single-agents in rodent models of NASH and liver fibrosis. The data indicate that combining agents had greater anti-fibrotic and anti-steatotic effects and led to improvements in liver biochemistry and fibrosis markers, compared with either agent alone.
As a result, Gilead has initiated a larger phase IIb study in combination treatment with selonsertib, and/or GS-0976, and/or GS-9674 in patients with advanced fibrosis due to NASH.
Given the persistent decline in the HCV franchise, Gilead is looking to foray into markets like NASH and CAR-T as they hold great potential. Per estimates, NASH is expected to surpass hepatitis C as the leading reason for liver transplants in the United States and Europe.
Gilead’s stock has lost 4.6% in the last six months as against the industry’s decline of 15.5%.
Intercept Pharmaceuticals (ICPT – Free Report) is also evaluating its lead candidate, obeticholic acid, in a phase III study in subjects with compensated cirrhosis due to NASH. Bristol-Myers Squibb (BMY – Free Report) has a mid-stage candidate in the NASH space. BMS-986036, an investigational pegylated analogue of human fibroblast growth factor 21 (FGF21), a key regulator of metabolism, in patients with biopsy-confirmed NASH (F1-F3) achieved its primary endpoint of significant reduction in liver fat versus placebo.
Gilead currently carries a Zacks Rank #4 (Sell).
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