CoDa Therapeutics has announced that it now has an open IND (Investigational New Drug application) after review by the US FDA (Food and Drug Administration).

The company had previously received approval by New Zealand’s MedSafe and Multi-Regional Ethics committee and is now initiating clinical trials for its lead compound Nexagon™. CoDa’s first trial is a Phase 1 clinical trial in patients following photorefractive keratectomy (PRK).

It is a randomized, prospective, double-masked, vehicle-controlled, dose-escalation study to evaluate the safety, tolerability and clinical effect of Nexagon™ in subjects following bilateral PRK for the correction of mild to moderate myopia.

The trial will be conducted at Auckland Eye, Remuera, Auckland, in 24 eligible subjects recruited in sequential cohorts of 6 subjects with follow-up continuing for 30 days after a single topical application of Nexagon™ or Nexagon™ vehicle. The primary objective will be assessed by safety evaluations in the 30 days post-application of investigational product.

The clinical trial will commence on May 19th 2008 and CoDa has recruited all 24 patients and successfully screened and booked the first cohort to undergo treatment on this day. A second Phase 1 trial to evaluate Nexagon™ in application to skin wounds is in process, and scheduled to begin in July.

CoDa Therapeutics is a biopharmaceutical company with a unique approach to wound healing, the company was founded on patented inventions and data generated in the laboratories of Professor Colin Green (University of Auckland) and Dr. David Becker (University College London) and is focused on the development and commercialization of therapeutics for wound care and tissue repair based on a new platform technology known as “Gap Junction Modulation.”). CoDa is building a portfolio of novel, proprietary compounds that, through control of gap junctions, can reduce cell to cell communication and improve wound healing and tissue repair post-injury. CoDa’s lead compound is Nexagon™