Federal Project Grant Award Summary

Merakris Therapeutics Inc. received a $1.1 million Project Grant award from the National Institute of Diabetes and Digestive and Kidney Diseases under the Diabetes, Digestive, and Kidney Diseases Extramural Research program (CFDA 93.847) on July 20, 2026. The award funds a direct-to-Phase II Small Business Innovation Research (SBIR) clinical trial evaluating the efficacy and safety of MTX-001, a first-in-class biologic therapeutic candidate designed to treat diabetic foot ulcers (DFUs). MTX-001 possesses anti-inflammatory, antimicrobial, anti-proteolytic, and pro-growth properties intended to address the underlying biological mechanisms that compromise wound healing in diabetic patients. The research builds on preliminary Phase 2 clinical trial results demonstrating MTX-001's safety and efficacy in treating venous leg ulcers, where the treatment produced an average 83% reduction in wound size and significant pain reduction over a 12-week treatment period.

The project addresses a significant clinical and economic need, as up to 34% of diabetes patients develop DFUs during their lifetime, with only 30%-40% of DFUs healing within 12 weeks despite current standard-of-care treatments. The grant supports Merakris's efforts to advance MTX-001 through Phase II clinical development for DFU indication, with an anticipated completion date of May 31, 2028. The work will be conducted at the company's facility in Hillsborough, North Carolina.