HEALEY ALS director says Clene warrants Phase III test despite miss
Evidence of a survival benefit at week 24 more than Amylyx therapy showed at same point, says Cudkowicz
Despite missing the primary endpoint in the HEALEY ALS platform trial, HEALEY Director Merit Cudkowicz views the data from Clene’s therapy as grounds for conducting a Phase III trial with a longer treatment period.
“Now we have two studies that are consistent at the 30 mg dose of a potential survival benefit, so it really begs the need to do a Phase III mortality study to confirm these findings,” Cudkowicz said Monday on a conference call to discuss the new findings. Cudkowicz is chief of the Department of Neurology at Massachusetts General Hospital, and director of the Sean M. Healey & AMG Center for ALS...