Merakris Therapeutics Begins Phase II Trial Enrollment for Venous Leg Ulcer Drug

Merakris Therapeutics has commenced the enrollment process for the second part of its Phase 2 clinical trial concerning Dermacyte® Amniotic Wound Care Liquid, a novel wound care drug. This stage of the trial, identified by NCT04647240, spans multiple centers across the United States, involving approximately ten medical facilities. This randomized, double-blind, placebo-controlled study aims to assess the drug's efficacy in treating venous leg ulcers (VLUs). The administering of doses is scheduled to start immediately.

Dermacyte® is an innovative biologic therapy injected beneath the skin, specifically designed to aid the healing process of VLUs. For this phase of the study, Merakris plans to include up to 50 participants, aged between 18 and 80, who suffer from chronic, non-infected VLUs ranging from 1 to 25 cm². These wounds must have manifested no more than 12 months prior to the onset of treatment and must have remained unresponsive to traditional wound care methods. The company anticipates concluding the study by late 2025.

In conjunction with this trial, Merakris has submitted an intermediate Expanded Access Protocol (EAP) to the US Food and Drug Administration (FDA). This protocol is designed to provide access to Dermacyte® Amniotic Wound Care Liquid for patients over 18 with severe wounds that severely impact their quality of life or pose a risk of amputation if unhealed. Subject to FDA approval and oversight from institutional review boards, Merakris aims to offer this investigational drug to patients on a case-by-case basis in collaboration with qualified research centers.

Upon approval, Dermacyte Amniotic Wound Care Liquid would represent the first biologic drug therapy available for VLUs, which are a significant health concern affecting between 500,000 and 2 million Americans each year. These chronic wounds contribute to reduced mobility and lower quality of life while incurring healthcare costs exceeding $3 billion annually. Effective new treatments could therefore alleviate both patient distress and financial burdens on the healthcare system.

"There is a substantial gap in wound care treatments, as the last drug approved by the FDA for cutaneous ulcers was over 25 years ago," stated Merakris Therapeutics CEO, Chris Broderick. "Open wounds not only cause significant physical and emotional distress to patients but also burden the healthcare system with billions in costs annually. Merakris is dedicated to introducing a pioneering drug that revolutionizes the standard of care for these stubborn conditions."

Merakris operates a Good Manufacturing Practice (GMP) facility in the Research Triangle Park (RTP) area of North Carolina, where it conducts the production of this investigational drug. The company is also expanding its manufacturing capabilities to support later-stage trials and future commercial supply.

As a leader in regenerative medicine, Merakris Therapeutics focuses on developing and bringing to market biologically derived products for wound healing and other complex medical conditions. Utilizing advanced biologic manufacturing techniques and a comprehensive research pipeline, the company strives to enhance patient outcomes and propel forward the science of regenerative therapies.