Shots:

• The MAA is based on the P-II (CENTAUR) trial to evaluate AMX0035 vs PBO in 137 adults with ALS at 25 centers of NEALS
• The results showed that the patients treated with AMX0035 showed a reduction in clinical decline @ 6mos. randomized phase as measured by ALSFRS-R. In survival analysis, 44% reduction in risk of death compared to PBO, median survival through open-label long-term follow-up (25.0mos. vs 18.5mos.)
• Additionally, marketing applications are currently under review for AMX0035 to treat ALS in the US & Canada. The enrollment for the P-III (PHOENIX) clinical trial is underway in the US & EU & provides safety & efficacy data for AMX0035 to support Amylyx’ regulatory efforts

Ref: Businesswire | Image: Businesswire