Print 09 January 2013
San Diego, California, January 8, 2013 – CoDa Therapeutics, Inc. today 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.”
Venous ulceration is the most serious consequence of chronic venous insufficiency commonly resulting from damaged veins and/or valves. The disease has been known for several millennia with wound care centers established as early as 1500 BC. Still 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. Of all ulcer types, venous leg ulcers are the most common, resulting in the loss of 2 million working days and nearly $3 billion in treatment costs per year in the US. The substantial costs associated with venous leg ulcers are related to the prevalence of the indication as well as the lengthy duration of treatment. The healing process for venous leg ulcers may take over a year in some cases and frequently requires significant healthcare resources during the healing process. Although venous leg ulcers place a significant burden on patients and the U.S. healthcare system, existing treatment options are unable to fully address this unmet need.
CoDa Therapeutics is a clinical stage biotechnology company focused on developing novel targeted therapies that address major unmet medical needs in inflammation, wound-healing and tissue repair. The company is pioneering a new field of science: gap junction modulation, using a new class of therapeutics that can modulate wound responses and reduce inflammation. CoDa has two open INDs and has completed two Phase 2 and three Phase 1 clinical trials in skin and eye, where NEXAGON® was shown to be safe and tolerable following administration to over 580 wounds on more than 370 subjects. CoDa’s technology, which can be conveniently applied topically, been shown to work across a wide variety of wound and inflammatory settings and conditions. CoDa presently has issued patents in the US, Europe and elsewhere, and pending applications in eighteen different patent families directed to methods and compositions for the treatment of acute wounds, chronic wounds, scarring, abnormal scarring, inflammation and pain, fibrosis, surgical adhesions, and orthopedic procedures, as well as combination therapies and improved medical devices. For further information, please visit www.codatherapeutics.com.
The active ingredient in NEXAGON®, which has been shown to work across a wide variety of tissues, is CODA001, a natural, unmodified antisense oligonucleotide that down-regulates the key gap junction protein connexin43 to dampen inflammatory responses and enhance healing. Data show that for optimal healing connexin43 is normally dialed-down at the edges of acute wounds (i.e., wounds that will heal normally). Conversely, other data demonstrate that connexin43 is wrongly up-regulated at the edge of chronic wounds (i.e., wounds that are difficult to heal such as venous and diabetic ulcers). CoDa believes that one can better target available medical options and design more effective wound-healing alternatives by devising a therapeutic approach based on biological mechanisms naturally at work or conversely, at fault, in a given situation. The answer is thought to lie in connexin43, which can be seen as a “master switch” in wound healing that is temporarily turned “off” for superior healing of acute wounds, and when left “on” can lead to the unwanted inflammation and/or stalled healing characteristic of chronic wounds.
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