Merakris Reports Positive Results For MTX-001 In Venous Leg Ulcers Ahead Of Late-Stage Trials

Merakris Therapeutics announced an update regarding its recent interactions with the U.S. Food and Drug Administration concerning the Investigational New Drug (IND) application for MTX-001, its investigational biologic being developed as a potential treatment for venous leg ulcers (VLUs).

As part of its communications with the FDA, the company submitted updated safety and clinical data from its ongoing programs, including the Phase II trial (DL-VSU-201) and the expanded access program (DL-EAP-201). These submissions provided cumulative information from 95 treated subjects, offering an expanded view of MTX-001’s clinical performance. In addition, Merakris shared real-world findings from an interim subgroup analysis conducted within the expanded access program.

This subgroup analysis identified 17 patients with chronic VLUs, nine of whom completed 12 weeks of therapy. Among these patients, treatment with MTX-001 demonstrated statistically significant reductions in ulcer size at both Week 8 and Week 12. To ensure meaningful evaluation, analyses excluded wounds smaller than 1 cm². Although expanded access studies have inherent limitations, the direction and consistency of the response aligned with outcomes previously observed in Part 1 of the Phase II trial, which was published in the International Wound Journal in March 2025.

Chris Broderick, Chief Executive Officer of Merakris Therapeutics, stated that seeing similar results across independent patient groups strengthens confidence in MTX-001’s potential as a treatment for venous leg ulcers. He also noted that recent alignment with the FDA during a Type C meeting—particularly regarding manufacturing scale-up and the production of registrational drug batches later this year—supports the company’s plans to progress MTX-001 into late-stage clinical development by 2027.

The Phase II study (DL-VSU-201) has recently been updated to incorporate a co-primary efficacy endpoint intended to support eventual product registration, reflecting the outcome of ongoing FDA discussions. Insights from both the Phase II program and the expanded access study are now being used to guide planning for future clinical development.

Merakris will present new scientific and clinical findings from its expanded access program at two major global wound-care conferences: the Wound Healing Society meeting and the Symposium on Advanced Wound Care (SAWC) Spring 2026 conference, scheduled for April 8–12 in Charlotte. MTX-001 remains an investigational therapy and has not yet been approved by the U.S. Food and Drug Administration for any indication.