Merakris Therapeutics Provides FDA Update and Reports Interim Findings for MTX-001 in Venous Leg Ulcers

RESEARCH TRIANGLE PARK, N.C., April 07, 2026 (GLOBE NEWSWIRE) -- Merakris Therapeutics today provided an update on recent communications with the U.S. Food and Drug Administration (FDA) related to its Investigational New Drug (IND) application for MTX-001, an investigational biologic being developed for venous leg ulcers (VLUs).

Merakris provided the FDA with updated safety and clinical data from its ongoing development programs, including its Phase II study (DL-VSU-201) and expanded access program (DL-EAP-201). These submissions included cumulative data from 95 treated subjects, reflecting continued clinical experience with MTX-001. Real-world data from an interim subgroup analysis of the expanded study was also shared with the Agency.

The subgroup analysis identified 17 patients with chronic venous leg ulcers (VLUs) of which 9 subjects completed 12 weeks of therapy. In this subgroup, MTX-001 was associated with statistically significant ulcer size reduction by Week 8 and Week 12. Analyses excluded wounds smaller than 1 cm² to ensure clinical relevance. While the expanded access design is inherently limited, the magnitude and direction of response in this refractory VLU subgroup were consistent with findings from Part 1 of the Phase II study, published in the International Wound Journal in March 2025.

“The reproducibility of this effect across independent patient cohorts reinforces our confidence in MTX-001 as a potential treatment for venous leg ulcers,” said Chris Broderick, Chief Executive Officer of Merakris Therapeutics. “Combined with recent FDA alignment from our Type C meeting to address manufacturing scale-up including the production of registrational drug batches this year, we believe MTX-001 is well-positioned to advance into late-stage development by 2027.”

The ongoing Phase II study (DL-VSU-201) has recently been amended to include a co-primary efficacy endpoint to support product registration based on recent FDA discussions. Data from both the Phase II study and expanded access program are being used to inform the design of future clinical studies.

Merakris will present new clinical and scientific data from its expanded access program at two of the field’s leading global conferences, the Wound Healing Society (WHS) and the Symposium on Advanced Wound Care (SAWC) Spring 2025, taking place April 8–12 in Charlotte, North Carolina.

MTX-001 is an investigational product and has not been approved by the U.S. Food and Drug Administration for any indication.

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.

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.

Contact:
Jonathan Berlent, MBA
Investor Relations
jberlent@merakris.com

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