Merakris aims to deliver a first-in-class drug and pioneer a new era within the wound care industry by commercializing regenerative medicine for hard-to-heal wounds
RESEARCH TRIANGLE PARK, N.C., Dec. 10, 2024 (GLOBE NEWSWIRE) -- Merakris Therapeutics is pleased to announce that enrollment is now open for Part 2 of its Phase 2 multicenter, clinical trial (NCT04647240) of its investigational wound care drug, Dermacyte® Amniotic Wound Care Liquid. The randomized, double-blind, placebo-controlled study will enroll patients across approximately 10 medical centers in the United States with dosing to begin immediately.
The biologic therapy, injected below the skin, is being developed to promote healing of venous leg ulcers (VLUs). Part 2 of this study will evaluate up to 50 patients between 18 and 80 years of age with chronic non-infected VLUs (1-25 cm2) that have occurred no more than 12 months prior to starting therapy and that failed to respond to conventional wound care. Merakris is targeting late-2025 for completion of the study.
Merakris has also filed an intermediate Expanded Access Protocol (EAP) with the US Food and Drug Administration (FDA) to provide access to Dermacyte® Amniotic Wound Care Liquid. Patients over 18 years of age that have serious wounds and face significant loss of quality of life or potential amputation if not healed would be considered for this investigational drug access. Pending FDA clearance and institutional review board approval, expanded access will be granted on a case-by-case to patients in collaboration with qualified research centers.
If approved, Dermacyte Amniotic Wound Care Liquid will be the first biologic drug therapy for the treatment of VLUs that pose a significant public health challenge, affecting approximately 500,000 to 2 million Americans annually. These painful, chronic wounds cause reduced mobility and a diminished quality of life while imposing an estimated annual healthcare cost exceeding $3 billion. Thus, safe and effective new treatments could significantly reduce patient, healthcare, and economic burdens.
“There is a major gap in wound care therapies as it has been over 25 years since the last wound healing drug was approved by FDA for cutaneous ulcers,” said Chris Broderick, CEO of Merakris Therapeutics. “Open wounds not only impose significant physical and emotional burdens on patients but also cost the healthcare system billions annually. Merakris is committed to pioneering a first-in-class drug that transforms the standard of care for these recalcitrant conditions.”
Merakris’ team has operated in a GMP facility in the Research Triangle Park (RTP), NC area to complete the investigational drug manufacturing and is scaling up its manufacturing capabilities for later stage investigational trials and commercial drug supply.
For more information on the clinical research program or the expanded access policy, please email Merakris’ medical affairs team at medaffairs@merakris.com.
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 and a robust research pipeline, Merakris is committed to improving patient outcomes and advancing the science 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. Investigational drug tradename (Dermacyte Liquid or Dermacyte Amniotic Wound Care Liquid) has not been approved by FDA.
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