RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--Merakris Therapeutics, LLC, a biotechnology company that is developing advanced biologic technologies derived from perinatal cells and tissues, files a Pre-IND meeting request with the FDA for Dermacyte Liquid (Amniotic Wound Care Liquid) for subcutaneous injection for the treatment of non-healing venous stasis ulcers.
The Company has commercialized and marketed Dermacyte Liquid as a minimally manipulated acellular amniotic fluid allograft pursuant to 21 CFR 1271, and has obtained clinical evidence that subcutaneous injection promotes healing in a variety of chronic wounds. The Company intends to discuss maintaining the commercial product status that complies with current Good Tissue Practices while executing a clinical study to evaluate the safety and efficacy in the treatment of venous stasis ulcers.
Merakris Therapeutics, LLC, now having submitted a request for a “Type B” Pre-IND meeting with the FDA, expects to gain valuable information to confirm or improve its clinical study design for this drug candidate. The proposed study design is largely influenced by the 21st Century Cures Act which outlines new approaches to clinical research for studying drug product effectiveness. The Company hopes to take advantage of existing clinical human safety data wherein no known adverse events have been reported. This may allow for an exemption from pre-clinical and early-stage clinical trials.
Through the Company's research and development program, it has shown that the biomolecules encapsulated in extracellular vesicles found in Dermacyte Liquid can activate epithelial-to-mesenchymal transition, a critical step in early phase wound healing. Additionally, the Company’s research program has also shown that the freely suspended/non-encapsulated biomolecules found in Dermacyte Liquid promote mesenchymal-to-epithelial transition, which specifically supports late-phase wound healing events such as re-epithelialization and keratinization. Based on this research, the Company filed patents in early-2019 and is working to optimize a fractionation process that adheres to Good Manufacturing Practice. It expects this will yield two additional product candidates for tissue engineering applications: an amniotic exosome-enriched product and an exosome depleted product. Chris Broderick, President says, “We are very encouraged by the outcomes around our research.” Lead Scientist, Sam Fagg, MSc, PhD adds, “By leaning on a solid science background, we find evidence that fractionation of Dermacyte represents a step toward precision wound healing.”
Merakris Therapeutics supplies amniotic tissue allografts to various healthcare markets and has developed a comprehensive market access program for its portfolio of Dermacyte Regenerative Wound Care products. These include both amniotic fluid- and membrane-derived technologies that support product adoption into physician offices and hospital outpatient markets. Merakris is pioneering commercially scalable biotherapeutic technologies primarily derived from perinatal cells and tissues and has filed patents to protect its amniotic fractionation technology and a unique co-stem cell culture technology that produces an amniotic fluid-like product that is currently under development. The company has also initiated a recruitment campaign to identify and strategically align with regional wound care distribution agencies across the U.S. and internationally.
Merakris Therapeutics, based in Research Triangle Park, North Carolina, is focused on researching, developing, and marketing regenerative healthcare products in the wound care, orthopaedic, and ocular fields. Merakris’ vision is to improve global patient care and outcomes by identifying and deploying innovative regenerative biotechnologies.