Merakris to Test Dermacyte Liquid in Humans
Research Triangle Park regenerative wound-healing product developer Merakris Therapeutics is launching human testing of a liquid to treat open sores on the skin known as non-healing venous stasis ulcers (VSUs).
Merakris has received U.S. Food and Drug Administration clearance for a Phase 2 clinical trial to test its investigational therapy, Dermacyte Amniotic Wound Care Liquid. The study will address the drug’s frequency of administration, safety and efficacy.
CEO Chris Broderick 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 Practices 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 said. “And we look forward to more-closely assessing the safety and efficacy of this product in our upcoming clinical trial.”
Therapy derived from donated amniotic fluid
Dermacyte Amniotic Wound Care Liquid is an acellular, sterile-filtered human amniotic fluid allograft, which means it’s made from amniotic fluid donated by mothers after childbirth.
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 forecast to reach $4.84 billion by 2026, Merakris reported. An estimated 500,000 to 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.
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 these components may unlock a new type of precision wound healing, based on a patient’s personal wound profile,” Broderick said.
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.
Product line includes tissue for skin, eyes
Merakris, 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.