RESEARCH TRIANGLE PARK, N.C., July 27, 2022 (GLOBE NEWSWIRE) -- The first patient has been enrolled in a Phase II clinical trial – sponsored by Merakris Therapeutics – to measure the safety and efficacy of its investigational wound care product, Dermacyte® Amniotic Wound Care Liquid, for the treatment of non-healing venous stasis ulcers.
The Research Triangle Park – headquartered biotechnology company is collaborating with the United States Department of Veterans Affairs (VA) to see how well Dermacyte Liquid, injected below the skin, promotes healing of chronic venous stasis ulcers (VSUs). These types of ulcers are caused by problems with blood flow in the veins of the legs and can result in series complications in patients when unhealed.
Dermacyte Liquid is a cell-free amniotic therapy that works by stimulating skin cell migration and activating gene expression pathways that promote wound healing.
Merakris has entered into a Cooperative Research and Development Agreement with the VA and is currently negotiating with additional clinical sites to conduct the two-part Phase II clinical trial (ClinicalTrials.gov Identifier: NCT04647240). It is designed to determine the safety, effectiveness, and frequency of administration of the investigational product.
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 estimated to approach $5 billion annually by 2026.
Part 1 of the study will enroll approximately 10 subjects between the ages of 18 and 75 years old who have non-infected VSUs that haven’t improved after at least four weeks of conventional wound therapy. Patients are randomized 1:1 to receive either Dermacyte Liquid on a once weekly or once biweekly schedule. They will be followed for 12 weeks. The first patient has already begun receiving the investigational treatment.
The data from Part 1 will be used to determine dosing frequency for the double-blinded and placebo controlled second part of the study. An estimated 30 participants will be recruited to participate, according to Merakris CEO Chris Broderick. The second stage also will last 12 weeks.
“The successful enrollment of the first subject in this clinical trial marks a significant milestone for our biotechnology company,” Broderick said. “Dermacyte Liquid contains the natural biomolecules present in amniotic tissues and fluids in an injectable form, 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 ten patent applications covering Dermacyte Liquid and its unique mode of action that date back to February of 2019 and plans to conduct more clinical studies in the future.
About Merakris
Merakris Therapeutics – founded in 2016 – 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 skin 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 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.
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