Genky­otex picks out sil­ver lin­ings from failed PhII, braces for piv­otal study in pri­ma­ry bil­iary cholan­gi­tis

Genky­otex’s Phase II pri­ma­ry bil­iary cholan­gi­tis tri­al was main­ly sup­posed to mea­sure re­duc­tion in gam­ma glu­tamyl transpep­ti­dase (CGT). But that may not be ob­vi­ous if you just read the com­pa­ny’s re­lease on the topline ef­fi­ca­cy re­sults.

That’s like­ly be­cause their drug, a NOX1&4 in­hibitor dubbed GKT831, failed the pri­ma­ry end­point. They did re­port a 19% re­duc­tion in CGT, but it’s not sta­tis­ti­cal­ly sig­nif­i­cant af­ter 24 weeks. Yet what the French biotech would like to spot­light are the sec­ondary end­points — a sta­tis­ti­cal­ly sig­nif­i­cant re­duc­tion in al­ka­line phos­phatase (p=0.002) and, for a sub­group of pa­tients who had more se­vere fi­bro­sis to start with, a 22% re­duc­tion in liv­er stiff­ness com­pared to a 4% in­crease in place­bo (p=0.038).

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