RESEARCH TRIANGLE PARK, N.C., Dec. 04, 2025 (GLOBE NEWSWIRE) — Merakris Therapeutics, a clinical-stage biopharmaceutical company focused on advancing innovative biologic drug therapies for chronic wounds, announced that it has successfully completed a Type C meeting with the U.S. Food and Drug Administration (FDA).
This results in meaningful regulatory alignment for clinical efficacy expectations, potency assay validation strategy, and manufacturing scale-up plans for its lead clinical asset, MTX-001, which is currently being developed for the treatment of chronic venous leg ulcers (VLU).
Ahead of the meeting, Merakris presented details on its potency assays undergoing current Good Manufacturing Practice validation. During the meeting, the FDA indicated alignment with the analytical approach and proposed mechanism of action. The Agency clarified certain requirements to be provided for acceptance of the proposed analytical methods. The Agency also discussed the manufacturing scale-up strategy for commercial batch sizes and defined clear and executable deliverables that will enable large-scale production of MTX-001, strengthening the Chemistry, Manufacturing and Controls (CMC) roadmap.
The FDA provided constructive clinical feedback during the Type C meeting regarding the Company’s strategy to pursue a Biologic License Application. This feedback provides a clear and feasible clinical development pathway for MTX-001.
“This successful Type C meeting highlights a milestone achievement for our team at Merakris and materially strengthens the investment profile of MTX-001,” said Chris Broderick, CEO of Merakris Therapeutics. “With clinical, analytical, and manufacturing expectations clearly defined, we are well positioned to advance MTX-001 toward late-stage development and potential partnering opportunities.”
Merakris is developing MTX-001 with the goal of addressing the significant unmet need in chronic wound care, where there are currently no FDA-approved drugs specifically indicated for non-healing venous leg ulcers.
About MTX-001
MTX-001 is a first-in-class injectable biologic drug candidate purified from cell-free amniotic fluid. It is currently being evaluated in a Phase 2, multicenter, double-blind placebo-controlled trial (NCT04647240) for venous leg ulcers (VLUs) and is also available through an Expanded Access Program (EAP) for complex cutaneous wounds (NCT06730022). Interim data from the ongoing Phase 2 study, was published in the International Wound Journal in March 2025.
For more information about our investigational new drug or our clinical trials please visit www.merakris.com or contact Merakris’ Medical Affairs department at medaffairs@merakris.com.
About Merakris Therapeutics
Merakris Therapeutics is a leading innovator in regenerative medicine focused on developing and commercializing biologically derived products for wound healing and other complex conditions. Leveraging advanced biologic manufacturing capabilities and a robust research and development pipeline, Merakris is committed to improving patient outcomes and advancing the science of regenerative therapies.