Regulatory Update on Clinical Development Plan for Muzastotug in MSS-CRC Announced Following Productive Type B (End of Ph 1) Meeting with FDA
Peter Luo, Ph.D., CEO and President of R&D at Adagene added, “Our Phase 1b/2 trial has produced robust dose-dependent efficacy data with a potential best-in-class safety profile, identifying two optimized dose levels for the Phase 2, consistent with Project Optimus. With the FDA’s endorsement to advance into the Phase 2 part of the clinical trial, we’d like to thank our strategic partner, Merck, for supplying pembrolizumab to support this exciting randomized dose optimization cohort to identify a single dose to take into Phase 3, a critical step towards registrational trial for FDA approval.”
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