Promising NZ wound care treatment one step closer to market

 A drug co-invented by a University of Auckland researcher and part funded by a New Zealand venture capital company is one step closer to entering the multi-billion dollar wound-healing market.



Phase 2 testing of the drug NEXAGON® is demonstrating startling results in tissue repair. The results have been described as “extremely exciting” and “very impressive” by leading specialist wound healing physicians in the United States.



The drug is being developed by CoDa Therapeutics Inc., a company with dual operations in NZ and the US that has been co-funded by BioPacificVentures, a New Zealand venture capital group and other international investors.



Globally, the wound-healing market is a multi-billion dollar business, but in the past therapeutic treatments have largely been ineffective. NEXAGON® works differently by blocking the mechanisms that impair wound healing and has application in a number of therapeutic areas including chronic and other slow-to-heal wounds.



The concept for a blocking therapy was developed by Professors David Becker from University College London and Colin Green from the University of Auckland .



Company operations began in late 2006 after American Brad Duft met Dr Green, formed CoDa Therapeutics, and raised US$23 million from investors in the US and New Zealand.



The company is currently spending around NZ$5 million a year in New Zealand as it runs human clinical trials, and prepares to take the development to market.



Having completed initial clinical trials in New Zealand and the United States CoDa Therapeutics is now moving towards Phase 3 trials which could see NEXAGON® available as a medicine in late 2013 or early 2014 according to Mr Duft who is President and CEO of the company.



He says the development of NEXAGON® is a great endorsement of the innovative and important research coming out of New Zealand. “It not only demonstrates the ability of New Zealanders to develop new therapeutics for world-wide use, but it adds to the rising base of knowledge and experience in New Zealand with regard to the growth and development of biotechnology companies including those, like CoDa, who have products that are targeted for major markets.”



“CoDa Therapeutics’ links to New Zealand have been a significant component in the company’s success,” Mr Duft added.



Professor Joerg Kistler, director of the Institute for Innovation in Biotechnology at the University of Auckland says the drug’s success to date represents another milestone for New Zealand research.



“The University is internationally recognised for its world-class biomedical science. CoDa Therapeutics is at the cutting edge of commercialising academic research and improving the quality of life for patients world-wide,” Professor Kistler says. “CoDa is one of New Zealand's leading biotechnology companies and the continued success of NEXAGON® constitutes a significant step forward for the growth of the bio-industry in New Zealand.”



CoDa announced positive results from its initial Phase 2 trial for treating patients with chronic venous leg ulcers. Dr David Eisenbud, a former president of the American Academy of Wound Management, described the NEXAGON® treatment results as “extremely exciting,” saying that they “far exceed expected healing outcomes with current standard-of-care treatments.”



Healing of chronic venous ulcers is not usually observed until at least 12 weeks or longer with current therapies, and some can take years. “The NEXAGON ® treatment results showing a 31 per cent incidence of complete healing at just four weeks are remarkable. I am impressed by the clinical data that have been generated to date, all of which suggest safety and outstanding efficacy for this compound,” says Dr. Eisenbud.

Mr Duft says the Phase 2 study represents an important milestone for CoDa. “Chronic wounds represent one of the most significant unmet medical needs in the world today, and the data supports our conviction that CoDa’s technology could change the face of wound healing.”

He says 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.

Treating venous leg ulcers can be time-consuming and costly, affecting patients' quality of life. It is estimated that venous leg ulcers affect more than half a million people in the United States every year and it is by far the most common type of chronic wound seen. They account for the loss of two million working days and incur nearly US$3 billion per year in treatment costs in the US alone.

Online: www.codatherapeutics.com

About CoDa Therapeutics Inc.
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 1 clinical trials in skin and eye, where NEXAGON® was shown to be safe and tolerable following administration to over 250 wounds on more than 60 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 more than a dozen other 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.

About NEXAGON® - 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 shows 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.