Amy­lyx spot­lights a PhII suc­cess in slow­ing ALS pro­gres­sion. And they’re tak­ing it to the FDA

Just a cou­ple months af­ter pulling in a $30 mil­lion Se­ries B round, Amy­lyx is mak­ing an­oth­er splash with what it hopes are promis­ing da­ta for one of the most no­to­ri­ous­ly tough R&D fields.

The biotech pub­lished the re­sults of its Phase II/III tri­al in a pa­per for the New Eng­land Jour­nal of Med­i­cine on Wednes­day, re­search­ing whether its can­di­date AMX0035 could slow the on­set of amy­otroph­ic lat­er­al scle­ro­sis against a stan­dard-of-care-based place­bo. Based on the gold-stan­dard of ALS tests, which Amy­lyx used to mea­sure its pri­ma­ry end­point, AMX0035 showed a sta­tis­ti­cal­ly sig­nif­i­cant re­duc­tion in dis­ease pro­gres­sion over about six months.

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