RESEARCH TRIANGLE PARK – Research Triangle-based Merakris Therapeutics has a new drug product and an important new partner that will try it out.
The company has entered into a Cooperative Research and Development Agreement – or CRADA – with the United States Department of Veterans Affairs (VA) to test its investigational therapy, Dermacyte Amniotic Wound Care Liquid. The federal agency provides health care and other benefits to more than nine million of the nation’s military veterans annually.
The VA plans to enroll several dozen patients, ages 18-75, in a two-part Phase 2 clinical study to evaluate Merakris’ first-in-class subcutaneous – or below the skin – injectable wound healing product. The study will determine the frequency of administration, safety and effectiveness of Dermacyte Liquid in treating non-healing venous stasis ulcers (VSUs). These types of ulcers are caused by problems with blood flow in the veins of the legs.
“Wound care can be a huge issue for some of our veterans,” the VA said in a statement. “We are pleased to participate in studies like this one that are designed to contribute to the quality of life of veterans everywhere.”
Dermacyte Liquid is a sterile-filtered injectable solution made from human amniotic tissue and fluid, the protective liquid surrounding unborn babies. The product works by stimulating the migration of skin cells and triggering gene expression pathways to help wounds heal faster.
Amniotic fluid normally is discarded as medical waste during caesarean section deliveries. But increasing evidence suggests that it is a source of valuable biological material – including stem cells – that can be used in regenerative medicine.
Clinical trial to begin within next several weeks
If approved, Dermacyte Liquid will be the first subcutaneous biologic to treat VSUs, which account for between 60% and 80% of all leg ulcers. An estimated 500,000 to 600,000 people in the United States suffer from this condition each year. Fortune Business Insights – which provides research, forecasting and market studies for international businesses – predicts that the global market for treatments will reach close to $5 billion annually by 2026.
Merakris said prescreening will begin soon for patients with non-infected VSUs who haven’t improved after at least four weeks of conventional wound therapy. The clinical trial should begin within the next several weeks.
Participants will be randomized 1:1 to receive Dermacyte Liquid either weekly or biweekly in Part 1 of the study. That data will be used to determine the best dosing frequency for the double-blinded and placebo controlled second part of the study.
That stage will last 12 weeks. Reductions in participants’ VSU wound surface area will be measured against baseline in weeks four, eight and 12. Total wound closure also will be evaluated at the end of week 12.
“This clinical trial marks a significant milestone for our biotechnology company,” said Merakris CEO Chris Broderick. “Dermacyte Liquid contains the natural biomolecules present in amniotic tissues and fluids, and our data suggest that these components may allow us to usher in a new era of precision wound healing.”
Broderick said the company has filed patents covering Dermacyte Liquid and its unique mode of action and plans to conduct more clinical studies in the future.
Merakris Therapeutics – founded in 2016 and located in Research Triangle Park – pioneers the use of stem cell-derived biotherapeutic technologies to help heal damaged tissue. The company’s other products include:
- Dermacyte Matrix, a human amniotic membrane allograft that provides a protective covering to skin wounds and surgical sites.
- Opticyte Matrix, which creates an ophthalmic barrier to the corneal surface of the eye and can be used with various eye procedures.
(C) N.C. Biotech Center