Amylyx revealed full trial results in Denver.
After 48 weeks, over the entire period there was only a .343 difference in the decline of ALSFRS-R score vs placebo - not statistically significant.
Monepantel achieved .6 point decline per month in cohort 2 on 10mg vs 1.22 decline ( the expected ALSFRS-R decline on PRO-Act matched controls ), an improvement of roughly .6 points in rate of decline.
If this rate of reduction in decline were to be maintained for 48 weeks, this would represent 6.5 points to 7.5 point reduction in decline vs placebo ( vs Amylyx .343 ). Chalk and cheese, and a breakthrough for Monepantel.
This is why the data to be released with the OLE study is so important. If the reduction in rate of decline has been maintained for another 6 months it builds a compelling data set ( ALL patients have been on MPL for a minimum of 12 months - last patient cohort 2 dosed April 2023 ) , despite the low number of participants.
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- The Final Charge , Phase I/II MND Results & FDA ODD Approval Catalyst
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