Positive data from combination proof-of-concept could help to salvage Gilead’s NASH pipeline

Following the publication, at the International Liver Congress (ILC) 2019, of top-line data from a proof-of-concept study into Gilead’s combination therapy for NASH;

James Mather, MChem, Senior Pharma Analyst at GlobalData, a leading data and analytics company, offers his view on the impact these results could have on Gilead’s NASH pipeline:

“As the race to secure approval in the lucrative NASH indication, which GlobalData estimates will be worth $15.6bn by 2026 in the US alone; Gilead had appeared to falter earlier in 2019 with the subpar phase III results for selonsertib. The latest results offer hope to Gilead as it aims to reassure its stake in the NASH market through possible combination therapies.

“The results published give the first glimpse at the potential effectiveness of non-steroidal farnesoid X receptor firsocostat in combination with acetyl-CoA carboxylase inhibitor cilofexor. The results from 20 participants receiving once daily oral cilofelxor 30mg and firsocostat 20mg for 12 weeks demonstrated greater improvements in hepatic fat measurements and liver biomarkers.

“What is most impressive is that this combination, ciloflexor and firsocostat, produced a >30% reduction in hepatic fat measured through MRI-PDFF in 74% of patients; this is a significant improvement over the component monotherapies which achieved the same reduction in only 14% and 48% of patients in their respective phase II trials. These strong results therefore bolster Gilead’s target of becoming a major player in the future NASH market through combination therapies.

“The most exciting results from this phase II ATLAS trial will hopefully come later in 2019, as the much anticipated results of the combination therapies which include selonsertib are due to be published.”

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