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.
Investor Contact:
Jonathan Berlent, MBA
Investor Relations
jberlent@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.
Merakris Forward Looking Statements
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates regarding the marketing and other potential of Merakris’ products, or regarding potential future revenues from any such product. Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans” and similar expressions. Although Merakris’ management believes that any forward-looking statements in this press release are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Merakris, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the fact that product may not be commercially successful, the uncertainties inherent in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and volatile economic and market conditions may have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and advisors and on the global economy as a whole.
