Merakris Therapeutics, Inc. Announces FDA Clearance for Dermacyte® Liquid Clinical Trial
RESEARCH TRIANGLE PARK, N.C., May 25, 2021 (GLOBE NEWSWIRE) -- Merakris Therapeutics, Inc. (Merakris) announced that it has received U.S. Food and Drug Administration (FDA) clearance for a Phase II clinical trial involving its investigational new drug (IND), Dermacyte Amniotic Wound Care Liquid. The study will address the frequency of administration, safety and efficacy of Dermacyte Liquid in treating non-healing venous stasis ulcers (VSUs).
Merakris is a Research Triangle Park-based biotechnology business dedicated to the research, development and marketing of regenerative healthcare 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 team at Merakris – which includes experts in regulatory affairs, Good Clinical Practices, clinical data management, and clinical trial design and oversight – will manage the study. It will work with a Good Manufacturing Practice (GMP) laboratory partner to ensure that the investigational product is manufactured in accordance with all FDA requirements.
“We are excited about the potential benefits Dermacyte Liquid offers to patients in terms of healing difficult-to-treat venous leg ulcers caused by venous reflux disease,” Broderick stated. “And we look forward to more closely assessing the safety and efficacy of this product in our upcoming clinical trial.”
Dermacyte Amniotic Wound Care Liquid is an acellular, sterile-filtered human amniotic fluid allograft. Merakris’ lead scientist has shown that the product stimulates skin cell migration and activates the gene expression pathways required to promote wound healing. If approved, it will be the first subcutaneous (below the skin) biologic indicated for VSUs.
The global market for the treatment of venous leg ulcers was valued at $2.95 billion in 2018 and is forecasted to reach $4.84 billion by 2026, Merakris reported. An estimated 500,000-600,000 people suffer from VSUs in the U.S. alone. Topical cellular/biological skin graft substitutes are often used as advanced skin graft substitutes to treat VSUs.
Dermacyte Liquid contains the natural biomolecules present in amniotic tissues and fluids. In a discovery-based translational research project, the company has isolated various components of Dermacyte Liquid and is studying how it affects the stages of wound healing. “The data from the project suggest 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 pointed out.
He said the company has filed patents covering Dermacyte Liquid and its unique mode of action and plans to conduct additional pre-clinical and clinical studies to evaluate the product’s safety and efficacy in cutaneous wound healing.
MerakrisTherapeutics, founded in 2016, is pioneering 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 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.
The company also is investigating other novel biotechnology solutions to promote wound healing and skin rejuvenation.
About the Dermacyte® Liquid Phase II Clinical Trial
Dermacyte Liquid will be evaluated in a Phase II clinical trial entitled, “A Two-Part, Randomized Study of Dermacyte Amniotic Wound Care Liquid for the Treatment of Non-Healing Venous Stasis Ulcers.” The clinical trial has been designed to include an initial open-label study group (Part 1) followed by a randomized, double-blind, placebo-controlled study group (Part 2) in subjects with a non-infected venous stasis ulcer (VSU) that has failed to demonstrate improvement after receiving at least 4 weeks of standard, conventional wound therapy to evaluate the efficacy and safety of the biological drug product.
The run-in phase of the study (Part 1) will enroll 10 eligible subjects. In Part 1, patients will be randomized 1:1 to receive active Dermacyte once weekly or once every two weeks with standard of care. The data from Part 1 will be reviewed to determine the administration frequency of the study product (once 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 of care. Subjects will be followed for 12 weeks.
Subjects will receive localized subcutaneous injection of Dermacyte Liquid or placebo into and/or around the wound bed during clinic visits over a 12-week period and assessed for safety and efficacy measures at Screening, Baseline, and Weeks 4, 8, and 12. Percent reduction of the wound surface area will be formally collected at Baseline, Weeks 4, 8, and 12. To assess healing, the ulcer will be evaluated by assessing the change in the surface area (L X W) from Baseline. Overall change in patient reported pain scores from Baseline to Week 12 will be evaluated and total wound closure will be evaluated 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 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.
Contact: Chris Broderick