Evaluation of efficacy and safety of MTX-001 in diabetic foot ulcers

The National Institute of Diabetes and Digestive and Kidney Diseases awarded Merakris Therapeutics Inc. $2,219,008 on July 20, 2026, to conduct a Phase II clinical trial evaluating the efficacy and safety of MTX-001, a first-in-class biologic therapy, in treating diabetic foot ulcers.

MTX-001 is a biologic with anti-inflammatory, antimicrobial, anti-proteolytic, and pro-growth functions. Preliminary Phase II results from treating venous leg ulcers demonstrated safety, an average 83 percent reduction in wound size, and significant pain reduction over 12 weeks of treatment. The funded work will extend this investigation to diabetic foot ulcers, where current standard-of-care treatments achieve healing rates of only 30 to 40 percent at 12 weeks.

This award is a Project Grant under the Diabetes, Digestive, and Kidney Diseases Extramural Research program (CFDA 93.847), which supports extramural basic and clinical biomedical research improving understanding of disease mechanisms and leading to improved prevention, diagnosis, and treatment. The award is structured as a direct-to-Phase II Small Business Innovation Research (SBIR) grant to the for-profit firm.

Performance is located in North Carolina and runs through May 31, 2028.

Abstract

More than 37 million people in the united states have diabetes. Up to 34% of all patients with diabetes develop a diabetic foot ulcer (DFU) during their lifetime, contributing to a staggering rate of 18.6 million worldwide dfus every year. On average, 50-60% of dfus become infected, with about 20% of infections requiring foot and/or leg amputations. Apart from impaired physical function and reduced quality of life (QOL), patients suffering from dfus have a higher risk of dying. Additionally, DFU patients have $11,710 - $16,883 higher annual health care costs compared to diabetic patients without DFU - amounting to a staggering $9 - 13 billion in direct cost of treating DFU in the united states each year. The current standard of care for treating dfus is managing diabetes; getting weight off of the wound; removing dead, dying, or infected tissue; antibiotics; and/or wound dressings/bandages to provide a moist environment that supports tissue growth. Despite various treatment options, only 30% - 40 % of dfus heal at 12 weeks, with 23% of patients having non-healed dfus at 12 months. This is mainly due to ineffective treatments that fail to address the biological reasons that wound healing is compromised in patients with diabetes. Altogether, there is a growing need to develop novel wound healing therapies to improve DFU wound healing. Merakris therapeutics is developing MTX-001, a first-in-class biologic therapy. MTX-001 has anti-inflammatory, antimicrobial, anti-proteolytic, and pro-growth functions that improve wound healing. Our preliminary results from a phase 2 clinical trial for treating venous leg ulcers (VLUS) show MTX-001 is a safe treatment that leads to an average 83% reduction in wound size and a significant reduction in patient pain during 12 weeks of treatment. We now intend to show that MTX-001 is also effective for treating dfus. The goal of this direct-to-phase II sbir project is to conduct a randomized placebo-controlled trial to evaluate MTX-001 as a DFU treatment. We will recruit 80 patients with full-thickness non-healing dfus and treat them with weekly treatments of either MTX-001 or placebo. We will study safety and efficacy (both wound size and pain reduction). Success of this direct-to-phase II sbir and clinical trial will ultimately enable merakris therapeutics to bring a novel biological drug product to the clinic for patients with non-healing dfus.