RESEARCH TRIANGLE PARK, N.C., Feb. 08, 2022 (GLOBE NEWSWIRE) -- Merakris Therapeutics announced that it has entered into a Cooperative Research and Development Agreement (CRADA) with the United States Department of Veterans Affairs (VA) to test its investigational drug product, Dermacyte® Amniotic Wound Care Liquid.
The VA plans to enroll patients, ages 18-75, in a two-part Phase II clinical study (DL-VSU-201) to evaluate Merakris’ first in class subcutaneous – or below the skin – injectable wound healing therapy. The study is designed to address the frequency of administration, safety and efficacy of Dermacyte Liquid in treating non-healing venous stasis ulcers (VSUs). These types of ulcers are caused by problems with blood flow in the veins of the legs.
The therapy consists of an acellular, sterile-filtered human amniotic fluid allograft. It works by stimulating skin cell migration and activating gene expression pathways that promote wound healing.
“Wound care can be a huge issue for some of our veterans,” the VA said in a statement. “We are pleased to participate in studies like this one that are designed to contribute to the quality of life of veterans everywhere.”
If approved, Dermacyte Liquid will be the first subcutaneous biologic indicated for VSUs, which account for between 60 and 80 percent of all leg ulcers. An estimated 500,000-600,000 people suffer from this condition in the United States each year. Fortune Business Insights forecasts that the global market for treatments will reach close to $5 billion annually by 2026.
Merakris said prescreening will begin soon for patients with non-infected VSUs who haven’t improved after at least four weeks of conventional wound therapy. The clinical trial should be underway within the next several weeks. Participants will be randomized 1:1 to receive Dermacyte Liquid either weekly or biweekly in Part 1 of the study. That data will be used to determine dosing frequency for the double-blinded and placebo controlled second part of the study.
The second stage will last 12 weeks. Reductions in participants’ VSU wound surface area will be measured against baseline in weeks 4, 8 and 12. Total wound closure also will be evaluated at the end of week 12.
“This clinical trial marks a significant milestone for our biotechnology company,” said Merakris CEO Chris Broderick. “Dermacyte Liquid contains the natural biomolecules present in amniotic tissues and fluids, and our data suggest that these components may allow us to usher in a new era of precision wound healing.”
Broderick said the company has filed patents covering Dermacyte Liquid and its unique mode of action and plans to conduct more clinical studies in the future.
About Merakris
Merakris Therapeutics – founded in 2016 and headquartered in Research Triangle Park, North Carolina – pioneers the use of commercially scalable stem cell-derived biotherapeutic technologies to promote the healing of damaged tissue. Its mission is to improve global patient care and outcomes through regenerative biotechnologies. The company’s other products include:
- Dermacyte® Matrix, a human amniotic membrane allograft that provides a protective covering to cutaneous wounds and surgical sites.
- Opticyte® Matrix, which creates an ophthalmic barrier to the corneal surface of the eye and can be used with various ocular procedures.
Merakris also is investigating other novel biotechnology solutions that promote wound healing and skin rejuvenation.
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 include projections and estimates regarding the marketing and other potential of Merakris’ products, or regarding potential future revenues from any such products. 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; 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 that may impact us, our employees, advisors, customers, suppliers, vendors or other business partners – and the financial condition of any one of them – as well as the global economy as a whole.
