Merakris Therapeutics, a North Carolina-based clinical-stage biotechnology company, has received a Direct-to-Phase II Small Business Innovation Research (SBIR) award of approximately USD 2.2 million from the National Institute of Diabetes and Digestive and Kidney Diseases. The funding will support Merakris in pushing MTX-001, its lead biologic, into clinical testing for diabetic foot ulcers. The two-year, non-dilutive award (R44DK146625) allows the company to bypass a traditional Phase I SBIR study and move directly into a larger clinical program.
MTX-001 is a locally injected biologic purified from cell-free amniotic fluid, designed to act on two aspects of chronic wound biology simultaneously: dampening excessive inflammation and protease activity, and activating endogenous epithelial cells to support tissue regeneration. Most current wound-care products either provide passive coverage or target a single pathway, so a dual-mechanism approach is notable if it can be shown to improve healing rates beyond standard care. The NIH-backed study is planned as a randomized, placebo-controlled trial in which both arms receive standard debridement, off-loading and wound management, allowing a direct comparison of added biologic benefit.
The award extends Merakris' pipeline beyond its ongoing Phase II venous leg ulcer program (NCT04647240), which recently received FDA Fast Track designation, giving the company two clinical-stage indications within the multibillion-dollar chronic wound care market. Diabetic foot ulcers and venous leg ulcers remain areas of high unmet need, with existing regenerative and cellular wound therapies showing inconsistent efficacy in controlled trials.