South Korean biopharma AriBio receives EMA approval for phase 3 POLARIS-AD trial on Alzheimer's disease with AR1001 (Mirodenafil).
AriBio, a South Korean biopharma, receives EMA approval for phase 3 POLARIS-AD trial on Alzheimer's disease, aligning with US FDA and UK MHRA. The trial, involving 1,150 participants globally, tests AR1001's (Mirodenafil) efficacy and safety for early Alzheimer's patients with confirmed amyloid pathology, using FDA/EMA-accepted primary endpoint CDR-SB and secondary endpoints like ADAS-Cog 13.
April 29, 2024
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