Merakris Therapeutics announces it has fully enrolled the first part of a two-part clinical trial to evaluate the safety, effectiveness, and administration frequency of its investigational wound care product, Dermacyte® Amniotic Wound Care Liquid.
RESEARCH TRIANGLE PARK, N.C., Dec. 05, 2023 (GLOBE NEWSWIRE) -- Merakris Therapeutics announces it has fully enrolled the first part of a two-part clinical trial to evaluate the safety, effectiveness, and administration frequency of its investigational wound care product, Dermacyte® Amniotic Wound Care Liquid. The therapy is being studied to treat non-healing venous stasis ulcers (VSUs).
The Research Tringle Park–headquartered biotechnology company plans to share its initial findings on December 6 at the Desert Foot Multi-Disciplinary Limb Salvage and Wound Care Conference in Phoenix, AZ. Part 1 of the clinical trial should be completed by the end of this year.
Merakris is collaborating with the United States Department of Veteran Affairs and other US-based clinical study sites to assess the safety and efficacy of Dermacyte Liquid, injected below the skin, in promoting the healing of chronic VSUs. These ulcers are caused by problems with blood flow in the veins of the legs and can result in serious complications if they aren’t treated effectively.
If approved, Dermacyte Liquid will be the first subcutaneous biologic therapy indicated for the treatment of VSUs, which account for 60-80% of all leg ulcers that occur in the presence of venous disease. An estimated 500,000 – 600,000 people suffer from this condition in the United States alone each year. The global market for treatments is expected to reach close to $5 billion annually by 2026.
Part 1 of the two-part study enrolled 10 subjects between the ages of 18 and 75 years old with non-infected VSUs without improvement after at least four weeks of conventional wound therapy. Merakris will discuss its interim data at a workshop on the first day of the four-day Desert Foot Conference.
“Merakris’ regulatory compliance to Good Clinical Practices has been verified through successful internal audits of our clinical sites and we are well positioned to continue studies through the required Phase III pivotal trials,” said Merakris Vice President of Quality and Regulatory Mark Rogers. “We are also continuing to add clinical trial expertise to further enhance GCP compliance, ongoing clinical success, and an eventual Dermacyte Liquid BLA filing for VSUs.”
Merakris said the findings from Part 1 will be used to determine dosing and frequency of administration for a double-blinded, placebo controlled 12-week second phase of the clinical study, scheduled to begin in early 2024 following FDA review of safety data. An estimated 30 participants will be recruited for Part 2, according to Merakris CEO Chris Broderick.
Broderick said the company, which has filed 10 patent applications covering Dermacyte Liquid and its unique mode of action, plans to conduct more clinical studies in the future.
About Merakris
Merakris Therapeutics, founded in 2016, is at the forefront of scientific advancement in regenerative medicine. Dedicated to championing a precision medicine approach to wound care, Merakris seeks to improve global patient care and outcomes with cell-free regenerative therapies. The company also is investigating other novel biomedical solutions that promote wound healing and tissue regeneration.
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.
Bryant Haskins Otter Creek Communications bryanthaskins@gmail.com (c) 973 590 9537
