The company has completed the patient enrolment in the P-III trial (PHOENIX) evaluating AMX0035 vs PBO in a ratio (3:2) in patients with ALS at 65+ sites across the EU & US. The trial was based on the P-II trial (CENTAUR) results
The primary efficacy outcome will be a joint assessment of ALSFRS-R total score progression @~48wks. while the safety & tolerability will be assessed @~48wks. The results are expected in 2024
The MAA of AMX0035 is currently under the EMA’s review for ALS with a decision expected in H1’23 & the therapy continues to advance for other neurodegenerative diseases. The (CENTAUR) trial showed a significant benefit in function & survival in a post hoc analysis, rates of AEs & discontinuations were similar b/w groups
Ref: Businesswire | Image: Amylyx
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