An­nex­on’s GA drug miss­es on pri­ma­ry goal but win on vi­su­al acu­ity will be fo­cus of planned late-stage tri­al

An­nex­on’s com­ple­ment in­hibitor didn’t prove bet­ter than sham at re­duc­ing le­sion growth in a lead­ing cause of blind­ness, but the biotech still plans to move for­ward on the back of sec­ondary end­points show­ing vi­su­al acu­ity preser­va­tion, which will “cer­tain­ly” be the pri­ma­ry goal in a late-stage tri­al to be dis­cussed short­ly with the FDA, CEO Dou­glas Love told End­points News. 

The Cal­i­for­nia biotech’s ANX007 was not sta­tis­ti­cal­ly sig­nif­i­cant com­pared to pooled sham, the com­para­tor, at 12 months in pa­tients with ge­o­graph­ic at­ro­phy, per a Wednes­day pre­sen­ta­tion. In every-month dos­ing, the GA le­sion area changed about 6.2% from base­line (p=0.526) and 1.3% (p=0.896) in the every-oth­er-month group. In a March note, Jef­feries an­a­lyst Su­ji Jeong said a re­duc­tion of 20% to 30% would be “en­cour­ag­ing.”

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