RESEARCH TRIANGLE PARK, N.C., Feb. 20, 2024 (GLOBE NEWSWIRE) -- Merakris Therapeutics announced that it will present encouraging safety and efficacy data from the first of a two-part Phase 2 multi-center clinical study of its investigational wound care drug, Dermacyte® Amniotic Wound Care Liquid. The study consented 12 patients who were assessed for eligibility to receive the investigational drug treatment. Preliminary data indicate an 84% average reduction in ulcer surface area for the 9 patients completing the 12-week study. Six experienced total wound closure.
The therapy is being evaluated for the treatment of non-healing venous stasis ulcers (VSUs). The study included patients between 18 and 75 years of age with non-infected VSUs (1-25 cm2) after at least four weeks of conventional wound therapy. The VSUs must have been stable (no more than 25% change in surface area for 14 days prior to beginning treatment with Dermacyte Liquid).
Part 1 study data will be presented by Merakris’ Scientific & Medical Affairs Advisor Sean Connell, Ph.D., at the 2024 PRESENT Treasure Hunt Conference in Los Angeles during a workshop on Sunday, February 25th from 10:45 a.m. – 12:15 p.m. PST. The presentation will be followed by a demonstration of how the investigational product is administered.
The Research Triangle Park, N.C.-headquartered biotechnology company said Part 1 of the study was completed in January 2024. These data are being analyzed by the Merakris scientific team and an independent data safety and monitoring committee and will inform the design of Part 2 of the multi-center clinical study.
Merakris estimates that Part 2 of the double-blind, placebo-controlled trial will begin in July 2024 pursuant to FDA agreement of its Part 2 study design. The company said it will likely collaborate with as many as 10 sites to support patient recruitment, which will ensure a timely study completion and prepare the company for later stage trial designs.
Merakris is collaborating with the United States Department of Veteran Affairs and other US-based clinical study sites for this Phase 2 drug study to assess the safety and effectiveness of Dermacyte Liquid, injected below the skin, in promoting healing of chronic VSUs. These ulcers are caused by problems with blood flow in the veins of the legs and result in serious complications if they aren’t treated effectively.
If approved, Dermacyte Liquid will be the first subcutaneous biologic drug 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.
“We are delighted with the promising results from Part 1 of our two-part clinical trial and the promise of Dermacyte Liquid as a safe and effective treatment for non-healing venous stasis ulcers,” said Merakris CEO Chris Broderick. “This study demonstrates our commitment to developing a novel therapy to positively impact patients with VSUs. We look forward to starting Part 2 of our double-blinded, placebo controlled clinical study later this year.”
Merakris has filed 10 patent applications covering Dermacyte Liquid and its unique mode of action and plans to conduct additional clinical studies in the future, he added.
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, the company seeks to improve global patient care and outcomes with cell-free regenerative therapies.
In addition to Dermacyte® Amniotic Wound Care Liquid, its commercially available products include:
- Dermacyte® Matrix, a human amniotic membrane allograft that provides a protective covering to cutaneous wounds and surgical sites.
- Opticyte® Matrix, which provides an ophthalmic barrier to the corneal surface of the eye for use with various ocular procedures.
- Opticyte® Serum Tears, which can be used for the treatment of dry eye and corneal epithelial (outer layer) defects, and as an adjunct therapy to support optimization of the ocular surface before and after various clinical and surgical procedures.
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
