ARTICLE | Product Development

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

October 3, 2022 11:53 PM UTC

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...