Biotechnology company CoDa Therapeutics has closed the second half of its initial round of venture capital funding, putting it on target to begin clinical trials of its pioneering tissue repair drug by the end of this year.
The announcement brings Series A investment by United States-based Domain Associates and Australia-based GBS Ventures in CoDa Therapeutics Inc., the American arm of the business, to US$20 million. The first investment of US$10 million, made by Domain, was announced in October last year with negotiations on the second round concluded in mid-January.
Clinical trials of the wound care technology, Nexagon™, will be run through the New Zealand sister company, CodaTherapeutics (NZ) Ltd.
CEO Brad Duft says the investment gives CoDa the funds it needs to progress NexagonTM over the next two and a half years and means the company can stop pursuing financing for a period and focus on running its clinical trials.
“We begin meetings with the FDA (US Food and Drug Administration) in early March and are hopeful that, with the expertise we have sourced to help us prepare to meet regulatory requirements, the process will be smooth and we can begin dosing patients in New Zealand in December,” says Mr Duft.
Manufacture of the drug has already been initiated.
Mr Duft says four clinical sites in New Zealand are currently being considered for involvement in the trials – two in Auckland and one each in Wellington and Christchurch. One or two will ultimately be selected.
Nexagon™ was developed by Dr Colin Green, professor of Ophthalmology at the University of Auckland, in collaboration with Dr David Becker at University College London. The two scientists co-founded both CoDaTherapeutics (NZ) Ltd and CoDa Therapeutics Inc., with the US business spearheading commercial development while research remains in New Zealand and the UK. All early clinical development will also take place in New Zealand.
Mr Duft says securing the venture capital investment for CoDa Therapeutics Inc. is a significant achievement, given the string of failures with wound healing products to date.
“It’s a challenging area and many have tried and failed. Most drug development efforts to date have unsuccessfully tried to induce tissue growth in the face of the large genetic cascade that occurs when cells are damaged. We have taken a completely different approach which aims to shut down a single protein for just a few hours and then let the body take over and heal the wound naturally.”
The first trial will be for acceleration of healing in the eye following laser refractive surgery, where faster closing of the wound is needed to accelerate visual recovery and prevent a build up of scar tissue which can cause vision defects. Preclinical studies have shown that Nexagon™ can dramatically improve wound healing, with a single application reducing tissue death, swelling, inflammation and scarring; and accelerating time to wound closure. A second clinical trial will focus on skin wounds.
Mr Duft says running the clinical trials in New Zealand illustrates the strong commitment that CoDa US and CoDa NZ have to keeping important development activities here.
“We are committed to helping build biopharmaceutical capability in New Zealand – we’ve already hired two people here and hope they’ll soon be joined by a third, all of whom will gain additional valuable experience in drug development. It’s also cost effective to run trials in New Zealand and we benefit from the incredibly supportive environment for new technologies here.”