Merakris Therapeutics Secures $2.2 Million NIH SBIR Grant To Advance Diabetic Foot Ulcer Treatment

Merakris Therapeutics, a clinical-stage biotechnology company developing regenerative biologic medicines for chronic wounds, has received a Direct-to-Phase II Small Business Innovation Research (SBIR) award from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which is part of the National Institutes of Health (NIH). 

The funding will support the clinical development of the company's lead investigational therapy, MTX-001, for the treatment of diabetic foot ulcers (DFUs). The award provides approximately $2.2 million in non-dilutive funding over two years, allowing the company to continue advancing its research without giving up equity while expanding its clinical pipeline beyond venous leg ulcers (VLUs).

Commenting on the achievement, Chris Broderick, Chief Executive Officer of Merakris Therapeutics, said the award reflects independent recognition of the company's scientific research, Good Manufacturing Practice (GMP) manufacturing platform, and clinical development strategy. He added that the combination of NIH support, ongoing clinical programs, and the unique dual-action design of MTX-001 strengthens the therapy's long-term potential. According to him, receiving a Direct-to-Phase II award also validates both the company's therapeutic platform and its approach to clinical development.

The funding marks another important milestone in Merakris' long-term strategy of expanding its clinical, regulatory, and manufacturing capabilities while preserving capital through non-dilutive funding. The company continues to invest in strengthening its development programs and preparing MTX-001 for later stages of clinical research. This approach enables Merakris to advance innovation while maintaining financial flexibility for future growth.

MTX-001 is the company's lead investigational biologic and has been designed to address the underlying biological factors that prevent chronic wounds from healing properly. Unlike treatments that mainly provide wound coverage or target only one biological process, MTX-001 uses a dual-action mechanism. It is intended to reduce excessive inflammation and harmful protease activity to create a healthier wound environment while also activating the body's natural skin repair cells to encourage tissue regeneration and re-epithelialization. Merakris believes this combined approach could provide a more effective treatment option for patients with chronic wounds, including diabetic foot ulcers and venous leg ulcers.

As part of its clinical development plans, Merakris intends to work closely with the U.S. Food and Drug Administration (FDA) to discuss the development pathway for MTX-001 in diabetic foot ulcers. The NIH-supported study will evaluate the therapy using a randomized, placebo-controlled clinical trial involving patients with DFUs. All participants will continue receiving the current standard of care, including wound debridement, pressure off-loading, and routine wound management, allowing researchers to accurately assess the therapy's effectiveness alongside established treatment practices.

To support future clinical studies, the company has recently begun producing Good Manufacturing Practice (GMP) pilot-scale clinical material for MTX-001 while continuing to strengthen its Chemistry, Manufacturing and Controls (CMC) platform for larger-scale development. The new diabetic foot ulcer program complements Merakris' ongoing Phase II clinical trial evaluating MTX-001 for venous leg ulcers, which recently received FDA Fast Track designation. Together, these two clinical programs position MTX-001 as a promising regenerative biologic for two of the most common chronic wound conditions, addressing significant unmet medical needs while creating opportunities for future clinical and commercial growth.