Shots:
- AL-S Pharma has reported the global P-II (AP-101-02) trial data assessing AP-101 (IV, Q3W) vs PBO in 73 pts with sporadic ALS (n=52) & SOD1 mutations (n=21) for 24wks., followed by 24wk. OLE phase, where all pts received AP-101, & 16wk. safety follow-up
- Trial met its 1EP for safety & tolerability, with AP-101 showing disease modification & prolonged survival (composite EP) in ALS vs pts switching after PBO, supported by reduced NfL & pNfH biomarkers at 6mos.
- Benefits were observed in both sporadic ALS & SOD1-mutation carrier cohorts, alongside disease stabilization & reduced functional decline in SOD1-related pts; data to be presented in AD/PD 2026. Also, a P-III trial in ALS is expected to initiate by 2026-end
Ref: Businesswire | Image: AL-S Pharma | Press Release
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