CoDa Therapeutics Inc. announced positive results from a Phase 2b 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 3 registration trials. Venous leg ulcers are increasingly common and costly, and can be a cause of prolonged suffering for patients.
Nexagon was safe, and showed an increase in complete healing in the randomized, vehicle-controlled, double-blind, Phase 2b 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 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 3, and will review the steps to marketing approval at an upcoming end-of-Phase 2 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 2b study represent another important milestone for CoDa and provide future hope for the hundreds of thousands of patients who suffer from VLUs with no approved pharmaceutical therapies to heal these wounds."
Date: January 11, 2013
Source: CoDa Therapeutics Inc.