Promis­ing or in­con­clu­sive? Gilead fields PhII GS-4997 da­ta, trig­ger­ing more push­back on NASH claims

Gilead post­ed a de­tailed snap­shot of Phase II ef­fi­ca­cy da­ta for GS-4997, now known as selon­sert­ib, for NASH and liv­er fi­bro­sis, trig­ger­ing a mixed re­sponse of en­thu­si­asm and some clear skep­ti­cism from the an­a­lysts watch­ing this late-stage drug, some of whom got their first crack in when Gilead out­lined the top line da­ta from this study in Oc­to­ber.

The num­bers were de­tailed for selon­sert­ib alone, in com­bi­na­tion with sim­tuzum­ab or in sim­tuzum­ab alone. And in­ves­ti­ga­tors had a mixed bag of re­sults un­der­scor­ing drug ac­tiv­i­ty, rang­ing from the 43% of pa­tients tak­ing selon­sert­ib see­ing an im­prove­ment in fi­bro­sis com­pared to the 20% in the sim­tuzum­ab arm to the 20% in the selon­sert­ib arm ex­pe­ri­enc­ing a min­i­mum 15% re­duc­tion in liv­er stiff­ness to the 32% in the com­bo group and none tak­ing sim­tuzum­ab alone.

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