Merakris Therapeutics Reports Positive Interim Data for MTX-001 in Venous Leg Ulcers, Advances Toward Late-Stage Development
Key Insights
Merakris Therapeutics (search) reported statistically significant ulcer size reduction with MTX-001 in chronic venous leg ulcers (search) at Week 8 and Week 12 in an interim subgroup analysis.
The company submitted cumulative safety and efficacy data from 95 treated subjects to the FDA, including results from Phase II study and expanded access program.
FDA alignment on manufacturing scale-up and production of registrational drug batches positions MTX-001 for potential late-stage development by 2027.
Merakris Therapeutics (search) announced positive interim findings for its investigational biologic MTX-001 in treating venous leg ulcers (search) (VLUs), reporting statistically significant ulcer size reduction and advancing regulatory discussions with the FDA for late-stage development.
Clinical Data Shows Consistent Efficacy Signals
The company shared interim results from a subgroup analysis of 17 patients with chronic venous leg ulcers (search), of which 9 subjects completed 12 weeks of therapy. MTX-001 demonstrated statistically significant ulcer size reduction by Week 8 and Week 12. The analysis excluded wounds smaller than 1 cm² to ensure clinical relevance.
"The reproducibility of this effect across independent patient cohorts reinforces our confidence in MTX-001 as a potential treatment for venous leg ulcers (search)," said Chris Broderick, Chief Executive Officer of Merakris Therapeutics (search).
The interim findings were consistent with results from Part 1 of the Phase II study, which were published in the International Wound Journal in March 2025 and demonstrated favorable safety and early efficacy signals, including wound closure and symptom improvement.
Regulatory Progress and Manufacturing Scale-Up
Merakris provided the FDA with updated safety and clinical data from its ongoing development programs, including cumulative data from 95 treated subjects across its Phase II study (DL-VSU-201) and expanded access program (DL-EAP-201).
The company achieved FDA alignment from a Type C meeting to address manufacturing scale-up, including the production of registrational drug batches scheduled for this year. "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," Broderick stated.
Study Design Modifications and Future Development
The ongoing Phase II study (DL-VSU-201) has 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.
About MTX-001
MTX-001 is a first-in-class injectable biologic drug candidate purified from cell-free amniotic fluid. The therapy is currently being evaluated in a multicenter Phase 2 trial (NCT04647240) for venous leg ulcers (search) and is also available through an Expanded Access Program (EAP) for cutaneous wounds (search) (NCT06730022).
Merakris will present new clinical and scientific data from its expanded access program at the Wound Healing Society (WHS) and the Symposium on Advanced Wound Care (SAWC) Spring 2026, taking place April 8-12 in Charlotte, North Carolina.
MTX-001 remains an investigational product and has not been approved by the U.S. Food and Drug Administration (search) for any indication.