RESEARCH TRIANGLE PARK, N.C., Feb. 20, 2024 (Globe Newswire) — Melakris Therapeutics is in the first stage of a two-part, Phase 2, multicenter clinical trial of its wound treatment drug. announced that it will present encouraging safety and efficacy data. , skin cells® Amniotic wound care solution. This study consented 12 patients who were evaluated for eligibility to receive study drug treatment. Preliminary data shows that ulcer surface area decreased by an average of 84% in her nine patients who completed the 12-week study. Six experienced complete wound closure.
This therapy is being evaluated for the treatment of non-healing venous stasis ulcers (VSU). This study included patients aged 18 to 75 years with uninfected VSU (1 to 25 cm).2) after at least 4 weeks of conventional wound treatment. VSU must be stable (change in surface area must not exceed 25% for 14 days before starting treatment with VSU) skin cell fluid).
Part 1 research data will be presented by Dr. Sean Connell, Scientific and Medical Affairs Advisor at Melakris, during a workshop on Sunday, February 25th, at the 2024 PRESENT Treasure Hunt Conference in Los Angeles.th From 10:45 a.m. to 12:15 p.m. PST. The presentation will be followed by a demonstration of how the investigational drug is administered.
Research Triangle Park, a North Carolina-based biotechnology company, announced that Part 1 of the study was completed in January 2024. These data are being analyzed by the Melakrys scientific team and an independent data safety monitoring board and will influence the design of part 2 of the study. Multicenter clinical study.
Melacrys estimates that Part 2 of the double-blind, placebo-controlled study will begin in July 2024 in accordance with the FDA’s agreement on the Part 2 study plan. The company said it will likely collaborate with up to 10 sites to support patient recruitment, which will allow for timely completion of the study and preparation for later stage trial design.
Melacris is collaborating with the U.S. Department of Veterans Affairs and other U.S.-based clinical research facilities to evaluate the safety and efficacy of this Phase 2 drug study. skin cell fluid, injected under the skin to promote healing of chronic VSU. These ulcers are caused by blood flow problems in the leg veins and can lead to serious complications if not treated effectively.
If approved, skin cell fluid This is the first subcutaneous biological drug therapy indicated for the treatment of VSU, which accounts for 60-80% of all leg ulcers that occur in the presence of venous disease. An estimated 500,000 to 600,000 people suffer from this condition each year in the United States alone. The global market for therapeutics is expected to reach nearly $5 billion annually by 2026.
“We are excited by the encouraging results obtained in Part 1 of our two-part clinical trial and skin cell fluid as a safe and effective treatment for non-healing venous stasis ulcers,” said Chris Broderick, CEO of Melakrys. “This study demonstrates our commitment to developing new treatments that positively impact VSU patients. We look forward to starting the second part of our double-blind, placebo-controlled clinical study later this year.” I am.”
Merakris has filed 10 patents, including: skin cell fluid He added that it has a unique mechanism of action and plans to conduct additional clinical studies in the future.
About Melakris
Founded in 2016, Merakris Therapeutics is at the forefront of scientific advances in regenerative medicine. Dedicated to championing precision medicine approaches to wound care, the company aims to improve patient care and outcomes worldwide through cell-free regenerative therapies.
In addition to skin cells® Amniotic wound care solutioncommercially available products include:
- skin cells® matrixa human amniotic membrane allograft that provides a protective cover to the skin wound or surgical site.
- photoreceptor cells® matrixprovides an ophthalmic barrier to the corneal surface of the eye for use in various ophthalmic procedures.
- photoreceptor cells® serum tearscan be used to treat dry eye and corneal epithelial (outer layer) defects, and can also be used as an adjunctive therapy to support optimization of the ocular surface before and after various clinical procedures and surgical procedures.
Forward-looking statements about Melakrys
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 predictions and estimates regarding the marketing and other capabilities of Melakrys products or potential future revenues from such products. Forward-looking statements are typically identified by the words “expects,” “anticipates,” “believes,” “intends,” “estimates,” “plans” and similar expressions. Although Meracris’ management believes that the forward-looking statements contained in this press release are reasonable, investors should note that forward-looking information and statements are subject to various risks and uncertainties. Please note that many of these are difficult to predict and generally beyond Melakris’ control. , which could cause actual results or developments to differ materially from those expressed, implied or anticipated in the forward-looking information and statements. These risks and uncertainties include unanticipated regulatory actions or delays that may affect the availability and commercial viability of the products, general government regulation, and the possibility that the products will not be commercially successful. and the uncertainties inherent in research and development. future clinical data and risks associated with post-marketing, unanticipated safety, quality or manufacturing problems, competition generally, intellectual property, and related future litigation and the ultimate outcome of such litigation. Includes analysis of existing clinical data related to the product, including: Volatile economic and market conditions may affect the financial condition of us, our customers, suppliers, vendors or other business partners, or any of them, as well as our employees and advisors and the global economy as a whole; There is a possibility.
Bryant Haskins Otter Creek Communications bryanthaskins@gmail.com (c) 973 590 9537
