CoDa Therapeutics, a clinical stage biotechnology company, released positive results from a phase IIb clinical trial of Nexagon in patients with chronic venous leg ulcers, which supports advancing Nexagon into phase III registration trials.
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. Venous leg ulcers are increasingly common and costly, and can be a cause of prolonged suffering for patients.
Results showed that 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.
"CoDa's phase IIb clinical results are very exciting and reflect a well-designed and executed dosing phase study,” said Dr. William Marston, professor and chief of the division of vascular surgery at the University of North Carolina and medical director of the UNC Limb Salvage/Wound Healing Center. “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."
Dr. David Eisenbud, CMO at CoDa and former president of the American Academy of Wound Management, said, "The positive results from the NOVEL2 study substantiate our prior findings from previous VLU 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."