Merakris Therapeutics has announced the opening of enrollment for Part 2 of its Phase 2 multicenter clinical trial of Dermacyte® Amniotic Wound Care Liquid, an investigational drug for the treatment of venous leg ulcers (VLUs). This randomized, double-blind, placebo-controlled study (NCT04647240) will involve approximately 10 medical centers across the United States, with dosing commencing immediately.
The trial aims to evaluate the efficacy of the subcutaneous injection in promoting the healing of VLUs. Part 2 of the study will enroll up to 50 patients, aged 18 to 80, who have chronic, non-infected VLUs ranging from 1 to 25 cm² that have been present for no more than 12 months and have not responded to conventional wound care. Merakris anticipates completing the study by late 2025.
Addressing a Critical Unmet Need
Venous leg ulcers pose a significant public health challenge, affecting an estimated 500,000 to 2 million Americans each year. These chronic wounds lead to reduced mobility and a diminished quality of life, incurring annual healthcare costs exceeding $3 billion. The development of safe and effective treatments could substantially alleviate patient suffering and reduce healthcare expenditures.
According to Chris Broderick, CEO of Merakris Therapeutics, there has been a notable gap in wound care therapies, with no new drugs approved by the FDA for cutaneous ulcers in over 25 years. He emphasized the physical, emotional, and financial burdens imposed by open wounds and reiterated Merakris' commitment to pioneering a first-in-class drug to transform the standard of care for these conditions.
Expanded Access Protocol
In addition to the Phase 2 trial, Merakris has filed an intermediate Expanded Access Protocol (EAP) with the FDA to provide access to Dermacyte® Amniotic Wound Care Liquid for patients with serious wounds who face significant loss of quality of life or potential amputation. Expanded access will be granted on a case-by-case basis to patients in collaboration with qualified research centers, pending FDA clearance and institutional review board approval.
Manufacturing and Development
Merakris' team has been operating in a GMP facility in the Research Triangle Park (RTP), NC area to manufacture the investigational drug and is currently scaling up its manufacturing capabilities for later-stage trials and commercial supply.
