Part 2 of the Phase II multicenter clinical study for the investigational wound care drug, Dermacyte® Amniotic Wound Care Liquid, will begin late 2024
RESEARCH TRIANGLE PARK, N.C., Sept. 05, 2024 (GLOBE NEWSWIRE) -- Merakris Therapeutics today announced that the U.S. Food and Drug Administration (FDA) has granted clearance to commence Part 2 of its Phase II clinical trial (NCT04647240) evaluating Dermacyte® Amniotic Wound Care Liquid (a subcutaneous biological injection) after review of the initial clinical study data.
Dermacyte Amniotic Wound Care Liquid is being evaluated for the treatment of non-healing venous stasis ulcers (VSUs). Data obtained from Part 1 of the study indicate that six of the nine patients in the study achieved total wound closure. The average reduction in ulcer surface area was 84% at the end of the 12-week study. Additionally, a significant reduction in pain was observed in all patients that completed the study. The data from this Part 1 of the Phase II clinical trial will be presented in detail at the Symposium for Advanced Wound Care on October 3, 2024 in Las Vegas, Nevada.
Part 2 of the trial, expected to begin in late 2024, will involve approximately 45 patients across up to 10 clinical sites, including collaboration with the U.S. Department of Veterans Affairs. This phase will further assess the safety and efficacy of Dermacyte Liquid, with dosing frequency optimized based on FDA-reviewed Part 1 data further informing Phase III trial design. The company will submit data to FDA on its drug manufacturing facilities and investigational drug product prior to commencing study activities later this year.
If approved, Dermacyte Liquid would be the first subcutaneous biologic drug for VSUs, a condition affecting 500,000 to 600,000 people annually in the U.S. alone. The global market for wound care treatments is projected to reach $5 billion by 2026.
“Current wound care options often fail to deliver satisfactory results, leaving patients to suffer with ongoing pain and complications that reduces quality of life. Dermacyte Liquid, a first-in-class biologic, offers a promising new solution to help close chronic cutaneous wounds and improve patient outcomes,” said Chris Broderick, CEO of Merakris Therapeutics.
Merakris has filed 10 patents related to Dermacyte Liquid and plans to pursue additional clinical studies in support of its unique mechanism of action.
About Merakris Therapeutics
Founded in 2016, Merakris Therapeutics is a leader in regenerative medicine, focusing on precision-based wound care. The company’s commercial portfolio includes Dermacyte® Matrix, Dermacyte AC Matrix, Opticyte® Matrix, and Opticyte® Serum Tears.
- Dermacyte® Matrix, a human amniotic membrane allograft that provides a protective covering to cutaneous wounds and surgical sites.
- Dermacyte AC Matrix, a lyophilized full thickness human amnion-chorion membrane allograft for the protection of soft tissue defects.
- Opticyte® Matrix, a human extracellular matrix derived from amniotic tissue for the protection of corneal surfaces.
- Opticyte® Serum Tears, a point of care service for healthcare providers seeking rapid preparation of autologous serum tears.
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. Investigational drug tradename (Dermacyte Liquid) has not been approved by FDA.
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