CoDa Therapeutics, Inc., a biopharmaceutical company focused on the development and commercialization of therapeutics for wound care and tissue repair, today announced positive results from its Phase 2 NOVEL Study of NEXAGON® in patients with chronic venous leg ulcers. NEXAGON® is a topically applied, novel therapeutic candidate, with the potential to revolutionize the wound healing treatment paradigm by leveraging a new mechanism and target involved in the healing process.
NEXAGON® achieved the endpoints of safety, reduction in wound size and complete healing after four weeks in the randomized, vehicle-controlled, double-blind, Phase 2 NOVEL study. Based on these compelling results, CoDa plans to initiate additional NEXAGON® studies and has scheduled a near-term end-of-Phase 2 meeting with the FDA to discuss potential registration studies to support marketing approval.
The three-arm trial randomized 98 patients at multiple sites to receive low or high dose NEXAGON® treatment or vehicle, in addition to compression bandaging (standard-of-care). After only three applications over a four-week treatment period, high-dose NEXAGON® demonstrated a 69% reduction in the size of venous leg ulcers. In addition, complete healing of 31% of wounds seen in the high-dose treatment arm was five times higher than complete healing in the vehicle arm. Importantly, no drug-related adverse events were observed in either of the low or high dose NEXAGON® arms, confirming favorable safety results from previous preclinical and Phase 1 clinical studies.
Dr. Thomas Serena, a NOVEL Study Investigator, and Founder and Medical Director of the Penn North Centers for Advanced Wound Care, said, "The data from CoDa's Phase 2 NEXAGON® trial are very impressive therapeutically, especially considering the accelerated rate of complete wound healing and excellent safety profile after only four weeks of treatment. By targeting the inhibition of Connexin43, which may be a 'master switch' in wound healing, NEXAGON® is designed to improve both the rate and quality of tissue repair while managing inflammation. If patients can experience better and faster treatment outcomes, NEXAGON® has the potential to address significant treatment limitations and economic burdens imposed by chronic wounds on patients and insurers."
In the U.S., venous leg ulcers account for the loss of 2 million working days and nearly $3 billion in treatment costs each year. Duration of treatment may last over a year in certain cases, and frequently involves the use of significant healthcare resources, resulting in substantial costs for the U.S. healthcare system.
Dr. David Eisenbud, a vascular surgeon with expertise in wound evaluation and treatment, and former President of the American Academy of Wound Management, said, "The results from the Phase 2 NOVEL Study far exceed expected healing outcomes using today's standard of care. As a physician focused on wound healing, my own venous ulcer patients would benefit tremendously from a treatment that closes their wounds by an average of nearly 70% in just four weeks. That is simply not achievable right now, and the NEXAGON® treatment results showing a 31% incidence of complete healing at four weeks are remarkable. The healing process tends to be much slower, and other chronic wound healing studies usually use a 12-16 week treatment period. Given the rapid and significant wound healing and safety results seen in the Phase 2 study, additional studies of NEXAGON® are highly warranted in patients with venous leg ulcers."
In addition to Dr. Eisenbud, market research and interviews with practicing clinicians reveal that a product with the expected healing profile of NEXAGON® for chronic wounds would be seen as a major improvement over current standard of care treatments.
Bradford Duft, President and CEO of CoDa said, "After several years of intense work by a small and dedicated team, the results from this Phase 2 study represent a important milestone for CoDa. We are confident that the therapeutic potential of NEXAGON® will support our ongoing Series B financing and corporate partnering discussions. Chronic wounds represent one of the most significant unmet medical needs in the world today. The Phase 2 data support our conviction that CoDa's Gap Junction Modulation technology is at the forefront of a potential paradigm shift in how we treat patients with venous leg ulcers and other chronic wounds. With our clinical development program mapped out, we are poised to contribute a major improvement in the quality and rate of wound healing for these patients as well as the U.S. healthcare system. We look forward to our upcoming end-of-Phase 2 meeting with the FDA, after which we will share the details of our future development plans."