RESEARCH TRIANGLE PARK, N.C., Aug. 19, 2025 (GLOBE NEWSWIRE) -- Merakris Therapeutics today announced the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for U.S. Patent No. US-2022/0133806 A1, covering the company's proprietary method for isolating extracellular vesicles (EVs) from amniotic fluid for use in wound healing – representing a key element of the underlying technology platform for MTX-001, Merakris’ lead investigational new drug (IND) currently in Phase 2 clinical development.
MTX-001 is currently being evaluated in a multicenter, double-blind, randomized, placebo-controlled clinical trial (NCT04647240) for the treatment of chronic venous leg ulcers (VLUs). The allowed patent claims protect Merakris’ proprietary bioprocess and methods of use intended to modulate inflammation and support tissue regeneration at the wound site. By defining and securing this process, Merakris has created a strong intellectual property foundation for MTX-001 and future applications of this technology.
“This patent strengthens the intellectual property portfolio around MTX-001 and validates the scientific underpinnings of our regenerative platform,” said Chris Broderick, CEO of Merakris Therapeutics. “By protecting the core technology behind MTX-001, we’re not only advancing its development, we’re also unlocking broader opportunities to expand our pipeline of regenerative therapies.”
This U.S. patent expands Merakris’ growing intellectual property portfolio and reinforces the company’s leadership in developing additional cell-free regenerative therapies that may offer meaningful clinical benefit. The company is planning additional clinical development programs across a broader range of chronic and complex diseases.
About MTX-001
MTX-001 is a first-in-class injectable biologic drug candidate purified from cell-free amniotic fluid. It is being investigated for its ability to promote healing in chronic, non-healing wounds such as venous leg ulcers (VLUs) and diabetic foot ulcers (DFUs) through its primary VLU study and active expanded access clinical program for cutaneous wounds. Part 1 of the ongoing Phase 2 study, published in the International Wound Journal in March 2025, demonstrated favorable safety and early efficacy signals, including wound closure and symptom improvement. The therapy is currently in Part 2 of its multicenter Phase 2 clinical trial (NCT04647240) designed to further assess the initial findings and further evaluate safety, tolerability, and efficacy.
About Merakris Therapeutics
Merakris Therapeutics is a leading innovator in regenerative medicine focused on developing and commercializing biologically derived products for wound healing and other complex conditions. Leveraging advanced biologic manufacturing capabilities, a bold scientific team, and a robust research pipeline, Merakris is committed to improving patient outcomes and advancing the field of regenerative therapies.
Merakris Forward-Looking Statements
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates regarding the marketing and other potential of Merakris’ products, or regarding potential future revenues from any such product. Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans” and similar expressions. Although Merakris’ management believes that any forward-looking statements in this press release are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Merakris, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the fact that product may not be commercially successful, the uncertainties inherent in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and volatile economic and market conditions may have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and advisors and on the global economy as a whole.
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