Merakris Therapeutics, Inc. Announces FDA Clearance for Dermacyte® Liquid Clinical Trial
RESEARCH TRIANGLE PARK, North Carolina, May 25, 2021 (GLOBE NEWSWIRE) – Merakris Therapeutics, Inc. (Merakris) announced that it has received clearance from the United States Food and Drug Administration (FDA) for a phase clinical trial II involving its new investigational drug (INDIANA), Dermacyte Amniotic Wound Care Liquid. The study will focus on the frequency of administration, safety and efficacy of Dermacyte Liquid in the treatment of non-healing venous stasis ulcers (VSU).
Merakris is a Research Triangle Park-based biotechnology company dedicated to the research, development and commercialization of regenerative health products.
The company initially met with the FDA in 2020 to discuss the clinical trial and IND filing, according to CEO Chris Broderick. He said the Merakris team – which includes experts in regulatory affairs, good clinical practice, clinical data management, and clinical trial design and oversight – will manage the study. He will work with a Good Manufacturing Practices (GMP) partner laboratory to ensure that the investigational product is manufactured in accordance with all FDA requirements.
“We are excited about the potential benefits Dermacyte Liquid offers patients in terms of healing difficult-to-treat venous leg ulcers caused by venous reflux, ”said Broderick. “And we look forward to further evaluating the safety and efficacy of this product in our next clinical trial.”
Dermacyte Amniotic Wound Care Liquid is a sterile filtered cell-free human amniotic fluid allogeneic transplant. Merakris lead scientist has shown that the product stimulates skin cell migration and activates gene expression pathways necessary to promote wound healing. If approved, this will be the first subcutaneous (under the skin) biologic indicated for SUV.
The global venous leg ulcer treatment market was valued at $ 2.95 billion in 2018 and is expected to reach $ 4.84 billion by 2026, Merakris reported. An estimated 500,000 to 600,000 people suffer from UUS in the United States alone. Topical cellular / biological skin graft substitutes are often used as advanced skin graft substitutes to treat USV.
Dermacyte Liquid contains the natural biomolecules found in amniotic tissues and fluids. In a translational research project based on the discovery, the company has isolated various components of Dermacyte Liquid and is studying how it affects the stages of wound healing. “Project data suggests that these components may allow us to usher in a new era of precision wound healing, based on a patient’s personal wound profile,” Broderick said.
He said the company had filed for patents covering Dermacyte Liquid and its unique mode of action and plans to conduct additional preclinical and clinical studies to assess the safety and efficacy of the product in skin healing.
MerakrisTherapeutics, founded in 2016, is a pioneer in the use of biotherapeutic technologies derived from commercially scalable stem cells to promote healing of damaged tissue. Its mission is to improve care and patient outcomes around the world through regenerative biotechnologies. The company’s products include:
Dermacyte® Matrix, a human amniotic membrane allogeneic transplant that provides a protective coating to skin wounds and surgical sites.
Opticyte® Matrix, which provides an ophthalmic barrier to the corneal surface of the eye for use with various eye procedures.
The company is also investigating other innovative biotechnology solutions to promote wound healing and skin rejuvenation.
About Dermacyte® Liquid phase II clinical trial
Dermacyte Liquid will be evaluated in a Phase II clinical trial titled “A two-part randomized study of Dermacyte Amniotic Wound Care Liquid for the treatment of non-healing venous stasis ulcers.” The clinical trial was designed to include a first open-label study group (part 1) followed by a randomized, double-blind, placebo-controlled study group (part 2) in subjects with ulcer disease. of uninfected venous stasis (VSU). who has failed to demonstrate improvement after receiving at least 4 weeks of standard conventional wound therapy to assess the efficacy and safety of the biologic drug product.
The preliminary phase of the study (part 1) will recruit 10 eligible subjects. In Part 1, patients will be randomized 1: 1 to receive Active Dermacyte once a week or once every two weeks with standard care. The data from Part 1 will be reviewed to determine the frequency of administration of the study product (weekly or once every two weeks) in Part 2 of the study.
In Part 2, approximately 30 subjects will be randomized 1: 1 to receive Dermacyte Liquid or placebo with standard care. The subjects will be followed for 12 weeks.
Subjects will receive a localized subcutaneous injection of Dermacyte Liquid or placebo in and / or around the wound bed during clinic visits over a 12 week period and evaluated for measures of safety and efficacy at screening , at baseline and at weeks 4, 8 and 12. Percent reduction in wound area will be formally collected at baseline, weeks 4, 8 and 12. To assess healing, the ulcer will be assessed by assessing the change in area (LXW) from the start. The overall change in pain scores reported by patients from baseline at week 12 will be assessed and total wound closure will be assessed at week 12.
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 concerning the marketing and other potentials of Merakris products, or concerning the potential future revenues of such products. Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans” and similar expressions. Although the management of Merakris believes that the forward-looking statements contained 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. , which could cause actual results and developments to differ materially from those expressed, implied or projected in the forward-looking information and statements. These risks and uncertainties include, among others, unforeseen regulatory actions or delays, or government regulations in general, which could affect the availability or commercial potential of the product, the fact that the product may not be commercially successful, the inherent uncertainties. 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, general competition, risks associated with intellectual property and any related future litigation and the final outcome of such litigation, and volatile economic and market conditions may have on us, our customers, suppliers, vendors and other business partners, as well as on the financial condition of each of them, as well as our employees and advisors and the global economy in so n together.
Contact Person: Chris Broderick
Email: [email protected]