Merakris Therapeutics Enrolls 30th Subject in Expanded Access Program of MTX-001; Highlights Clinical Progress at SAWC Fall 2025
Enrollment milestone and ongoing study to be highlighted at SAWC Fall 2025; Merakris expanding clinical trial site partnerships
RESEARCH TRIANGLE PARK, N.C, Sept. 04, 2025 (GLOBE NEWSWIRE) -- Merakris Therapeutics, a regenerative medicine company developing biologically derived therapeutics, announced the enrollment of the 30th subject in its Expanded Access Program (EAP) of MTX-001. The investigational biologic drug is being evaluated in patients with chronic, non-healing wounds, including diabetic foot ulcers, venous leg ulcers, pressure ulcers, and surgical wounds.
Merakris will highlight its clinical programs at the SAWC Fall 2025 conference in Las Vegas this week. Attendees can visit Booth #440 to learn more about the company’s ongoing Phase 2 trial in non-healing venous leg ulcers, the EAP, and opportunities for new trial site participation.
MTX-001 is also being studied in an ongoing multicenter, Phase 2 double-blind, placebo-controlled trial focused on venous leg ulcers (VLUs). The company is actively expanding collaborations with additional researchers and clinical trial sites across the United States to further expand its clinical research network.
"Enrollment in our Expanded Access Program reflects continued momentum in advancing MTX-001 through clinical development toward patients in need," said Chris Broderick, CEO of Merakris Therapeutics. "By evaluating our investigational drug across multiple wound types, we are gathering real-world insights that complement our controlled clinical trial program while informing late-stage development plans."
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.
For more information about the MTX-001 clinical trial or Merakris’ Expanded Access Program, please visit www.merakris.com.
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.
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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