Merakris Therapeutics Secures FDA Agreement for Type C Meeting to Advance MTX-001 Development Pathway
RESEARCH TRIANGLE PARK, N.C., Sept. 30, 2025 (GLOBE NEWSWIRE) -- Merakris Therapeutics, a regenerative medicine company developing biologic drug therapies for hard-to-heal wounds, today announced that it is scheduled for a Type C meeting with the U.S. Food and Drug Administration (FDA) to discuss its clinical development program and manufacturing scale-up plans for its lead investigational drug, MTX-001.
The Type C meeting represents a formal opportunity for Merakris to engage with the FDA under its active Investigational New Drug (IND) application for the treatment of venous leg ulcers. The meeting will focus on critical elements of the MTX-001 development strategy — particularly as Merakris advances toward later-stage clinical trials and commercial-scale manufacturing. The FDA will provide feedback on the chemistry, manufacturing, controls plans (CMC), and ongoing Phase 2 clinical program for MTX-001 under the active IND through approval of a 351(a) Biologics License Application and subsequent commercialization.
The meeting is scheduled to be held on November 21, 2025, with multidisciplinary leadership attending from FDA’s Office of Therapeutic Products within the Center for Biologic Evaluation and Research and representatives from Merakris’ scientific, quality, and regulatory teams. It will be a virtual video conference meeting.
Key Objectives of the Type C Meeting Will Include:
- CMC (chemistry, manufacturing, and controls) expectations, including critical quality attributes and release assays, which includes quantitative and functional potency assays
- Alignment on manufacturing scale-up and product safety testing requirements for biological drugs
- Risk-mitigation strategies, addressing product consistency and batch comparability, and ongoing safety monitoring
- Discussion of the ongoing Phase 2, double-blind, placebo-controlled study for the treatment of venous leg ulcers and primary safety and efficacy endpoint measures
“This FDA Type C meeting is a significant regulatory milestone for progressing the MTX-001 clinical development program, as we move towards large-scale, efficient biologic drug manufacturing,” said Chris Broderick, CEO of Merakris Therapeutics. “It provides us with a structured forum to align our clinical, manufacturing, and regulatory plans with the FDA’s expectations, de-risking our path for completing our phase 2 and initiating phase 3 clinical trial and ultimately commercialization. We look forward to a productive dialogue and alignment with FDA as we advance MTX-001 to benefit patients with chronic, non-healing wounds.”
For strategic partnership and collaboration opportunities, please visit https://merakris.com/partnerships/.
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 multicenter Phase 2 trial (NCT04647240) for venous leg ulcers (VLUs) and is also available through an Expanded Access Program (EAP) for cutaneous wounds (NCT06730022). Part 1 of the Phase 2 study, published in the International Wound Journal in March 2025, demonstrated favorable safety and early efficacy signals, including wound closure and symptom improvement.
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 pipeline, Merakris is committed to improving patient outcomes and advancing the science of regenerative therapies.
Investor Contact:
Jonathan Berlent, MBA
Investor Relations
jberlent@merakris.com
Media Contact:
Garth Miller
Nova Marketing Solutions
garth.miller@novamktsolutions.com
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.
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