RTP’s Merakris lands $2.2M federal grant for diabetic food ulcer therapy
Key Takeaways
- Merakris Therapeutics received a $2.2 million federal grant for its diabetic food ulcer treatment
- The non-dilutive two-year funding will support clinical development of MTX-001, Merakris’ lead investigational biologic
- Merakris’s line of therapeutics includes amniotic membrane allograft products like Dermacyte Matrix, Dermacyte AC Matrix and Opticyte Matrix
Merakris Therapeutics, a clinical-stage Research Triangle Park regenerative biologic medicines company, has received a $2.2 million federal grant to advance commercialization of a diabetic food ulcer (DFU) treatment.
The funding is a Direct-to-Phase II Small Business Innovation Research (SBIR) award from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), part of the National Institutes of Health (NIH). The non-dilutive two-year funding is to support clinical development of MTX-001, Merakris’ lead investigational biologic designed to address the underlying biology responsible for chronic wound persistence.
The company said the award complements its ongoing Phase II clinical program evaluating MTX-001 in venous leg ulcers (VLUs). That study has received a U.S. Food and Drug Administration (FDA) Fast Track designation.
“This award represents independent validation of our science, our GMP manufacturing platform, and our clinical development strategy,” said Merakris CEO Chris Broderick in a news release. “We believe the combination of NIH support, our ongoing clinical programs, and our differentiated dual-action biology significantly strengthens the long-term value proposition of MTX-001. He added that the award “reflects independent scientific validation in both our therapeutic platform and our clinical development program.”
This award represents another significant milestone in Merakris’ strategy of systematically advancing its clinical, regulatory, and manufacturing capabilities while preserving capital through non-dilutive funding.
The company, founded in RTP in 2016, describes MTX-001 as a differentiated dual-action biologic unlike therapies that primarily provide wound coverage or target a single pathway. Instead, it’s designed to modulate excessive inflammation and protease activity, restoring a wound environment capable of healing, and also activate endogenous cells involved in cutaneous tissue repair and re-epithelialization, promoting regeneration of healthy tissue.
Merakris says simultaneously addressing these complementary biological processes may provide a differentiated therapeutic approach for patients with chronic wounds, including DFUs and VLUs.
Merakris’s NIH-supported study evaluated MTX-001 in patients with DFUs using a randomized, placebo-controlled clinical design, with both treatment groups receiving current standard of care, including appropriate debridement, off-loading, and wound management.
The company said it recently initiated production of GMP pilot-scale clinical material for MTX-001 and continues advancing its Chemistry, Manufacturing and Controls (CMC) platform to support later-stage development.
The company said its DFU and VLU programs target two of the largest advanced chronic wound indications, representing a substantial market opportunity with significant unmet medical need.
Merakris’s line of therapeutics includes amniotic membrane allograft products like Dermacyte Matrix, Dermacyte AC Matrix and Opticyte Matrix.