Amylyx’s ALS treatment Relyvrio fails PhIII study, biotech to consider withdrawing drug

Re­lyvrio, Amy­lyx’s FDA-ap­proved ALS drug, has failed a cru­cial Phase III tri­al, the com­pa­ny said on Fri­day, a ma­jor blow to what had been con­sid­ered one of the few sig­nif­i­cant op­tions avail­able for the treat­ment of the dead­ly neu­rode­gen­er­a­tive dis­ease.

The fail­ure is al­most cer­tain to put ac­cess to the drug in jeop­ardy, and Amy­lyx said it would con­sid­er with­draw­ing the drug.

In new Phase III tri­al da­ta re­leased Fri­day study­ing 664 ALS pa­tients, Amy­lyx’s drug failed to out­per­form a place­bo. The drug al­so missed all sec­ondary out­comes, which in­clud­ed qual­i­ty-of-life ques­tion­naires, as­sess­ing the spread of the dis­ease, and mus­cle func­tion. The p-val­ue on the tri­al’s main goal was 0.667, a high­ly non-sta­tis­ti­cal­ly sig­nif­i­cant re­sult.

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