Gilead shores up hope for NASH cock­tail with a glimpse at pos­i­tive proof-of-con­cept da­ta

When Gilead con­ced­ed fail­ure in its high-pro­file Phase III study for top late-stage NASH drug selon­sert­ib, CSO John McHutchi­son point­ed dis­ap­point­ed in­vestors to a com­bi­na­tion ap­proach be­ing test­ed in a mid-stage tri­al. Those da­ta are not ready just yet, but to­day the big biotech un­veiled some ear­ly num­bers to bol­ster their case for a cock­tail.

On dis­play to­day at the In­ter­na­tion­al Liv­er Con­gress are topline re­sults from a proof-of-con­cept study test­ing cilofex­or (non­s­teroidal far­ne­soid X re­cep­tor or FXR ag­o­nist) and fir­so­co­stat (acetyl-CoA car­boxy­lase or ACC in­hibitor). Out of 20 pa­tients who were treat­ed with the oral reg­i­men once dai­ly for 12 weeks, 74% ex­pe­ri­enced “a sig­nif­i­cant de­cline of at least 30 per­cent in he­pat­ic fat” — a hall­mark of the dis­ease.

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