CoDa Therapeutics, Inc. announced positive results from a Phase IIb clinical trial of NEXAGON® in patients with chronic venous leg ulcers. NEXAGON® is an easy to administer, once-a-week, topical, drug candidate being developed for the treatment of chronic wounds. It is designed to increase the incidence of wound healing compared to existing therapeutic techniques, and to heal them much faster. The company believes these results support advancing NEXAGON into Phase III registration trials.
Venous ulceration is the most serious consequence of chronic venous insufficiency commonly resulting from damaged veins and/or valves. Today, however, venous ulceration is a poorly managed medical condition notwithstanding that much has been learned about its pathogenesis and treatment. Venous ulcers account for 80%-85% of all leg ulcers with an overall prevalence of approximately 1-2% of the adult population in the United States, and typically appear as an open lesion, or ulcer, on the lower extremities, are very slow to heal, and often reoccur due to the chronic nature of the underlying disease process. For the more than 800,000 patients in the U.S. suffering from venous leg ulcers each year, the wound healing process is often time-consuming and costly, and may gravely impact quality of life.
NEXAGON® was safe, and showed an increase in complete healing in the randomized, vehicle-controlled, double-blind, Phase IIb study. CoDa is preparing a paper describing the results of this trial that will be submitted to a peer-reviewed medical journal.
Dr. William Marston, Professor and Chief, Division of Vascular Surgery at the University of North Carolina and medical director of the UNC Limb Salvage/Wound Healing Center, stated, “CoDa’s Phase 2b clinical results are very exciting and reflect a well-designed and executed dosing phase study. This data will provide clear information to choose an optimal dose and patient profile to move to a pivotal clinical trial. Upon successful completion of this phase, NEXAGON® would provide a much-needed therapeutic to accelerate healing of chronic venous leg ulcers.”
CoDa Chief Medical Officer Dr. David Eisenbud, former President of the American Academy of Wound Management, said, “The positive results from the NOVEL2 study substantiate our prior findings from previous venous leg ulcers studies and suggest that NEXAGON® could become a game changer: the first prescription medication to enhance the healing of venous leg ulcers. We are designing plans for Phase III, and will review the steps to marketing approval at an upcoming end-of-Phase II meeting with FDA.”
Bradford Duft, President and CEO of CoDa said, “The NOVEL2 trial has provided a wealth of valuable information regarding CoDa’s NEXAGON® drug candidate. Statistically significant results from this large Phase IIb study represent another important milestone for CoDa and provide future hope for the hundreds of thousands of patients who suffer from venous leg ulcers s with no approved pharmaceutical therapies to heal these wounds.”
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