Merakris Advances Potentially Pivotal MTX-001 Phase 2/3 Strategy Following FDA Pre-IND Meeting
FDA indicates proposed double-blind Phase 2/3 design could be considered adequate and well controlled as Merakris prepares its first commercial-pilot GMP drug lot f… Merakris Therapeutics, Inc., a clinical-stage biotechnology company developing regenerative biologic medicines, has received FDA Pre-Investigational New Drug (pre-IND) meeting for MTX-001 in diabetic foot ulcers (DFUs). The proposed double-blind Phase 2/3 trial could be considered adequate and well controlled as Merakris prepares its first commercial-pilot GMP drug lot for a potentially pivotal trial. The company plans to use its first GMP-manufactured drug lot as clinical supply for the proposed study, alongside additional GMP lots designed to establish manufacturing consistency and support future registration. The strategy is informed by FDA draft guidance recognizing that one adequate and controlled investigation may support marketing approval under appropriate circumstances. Merakristris continues its Phase 2 study of MTXX-002 in patients with chronic, non-healing VLUs (NCT04647240). The company also plans to submit a dedicated DFU IND separate from its ongoing clinical program in venous leg ulcers.
게시됨 : 어제 ~에 의해 GlobeNewswire ~에 Business Health
FDA indicates proposed double-blind Phase 2/3 design could be considered adequate and well controlled as Merakris prepares its first commercial-pilot GMP drug lot for a potentially pivotal trial. RESE... [6650 symbols]
주제: FDA
