Clinical Status

Two Phase 1 clinical trials in skin and eye are now complete. CoDa's lead product candidate, Nexagon^® was shown to be safe and tolerable following administration to wounds on over 60 human volunteers. One Phase 2 study to investigate the use of Nexagon^® in the treatment of venous leg ulcers is now complete and a Phase 2b study in venous leg ulcers was initiated in May, 2011.  A Phase 2 study to further investigate the use of Nexagon^® in the treatment of diabetic foot ulcers will be initiated in Q3, 2011. Additional clinical studies are underway including studies for treatment of ocular persistent epithelial defects and acute corneal trauma. Successful completion of CoDa’s next Phase 2 studies will position the company to advance to registration studies.

A Randomized, Prospective, Double-blind, Vehicle-controlled, Dose-ranging, Multi-center Study to Assess the Safety and Clinical Effect of Nexagon® in the Treatment of Subjects With a Diabetic Foot Ulcer.

Study initiated in July 2012

Purpose

This is a Phase 2 randomized, prospective, double-blind, vehicle-controlled, dose-ranging, multi-center study to evaluate the safety and clinical effect of Nexagon® at 3 dose concentrations plus standard-of-care (SOC) when applied twice-weekly to diabetic foot ulcers.  This study aims to determine the selection of the most suitable dose concentration of Nexagon® to be used for the treatment of diabetic foot ulcers. The study is for Type I or Type II diabetic subjects with a diabetic foot ulcer. Standard of care will include debridement of the ulcer, standardized dressings and standardized off-loading using a Non-removable Cast Walker.

Study Type:	Interventional
Study Design:	Allocation, Randomized Endpoint Classification, Safety/Efficacy Study Intervention Model, Parallel Assignment Masking, Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose, Treatment
Study Title:	A Randomized, Prospective, Double-blind, Vehicle-controlled, Dose-ranging, Multi-center Study to Assess the Safety and Clinical Effect of Nexagon® in the Treatment of Subjects With a Diabetic Foot Ulcer
Estimated Enrolment:	160
Intervention	Nexagon® Nexagon® vehicle
Phase:	Phase II

clinicaltrials.gov

The NOVEL Study: A trial to assess the Safety and Activity of Nexagon^® for the Treatment of Venous Leg Ulcers

Study Completed.

Purpose

Venous leg ulcers are a common, costly and debilitating condition, with few effective treatments. Compression bandaging helps healing, but more than four out of every ten leg ulcers remain unhealed after three months. New treatments to help heal venous ulcers are urgently needed. Initial studies with a new drug product candidate called Nexagon^® (developed by CoDa Therapeutics, Inc.) have shown improvements in healing when applied topically to a wound. Further research will be undertaken to assess the safety and activity of Nexagon^® when applied to venous leg ulcers in humans, and to obtain further information on the most appropriate dose or doses to apply. A proposed randomized controlled trial aims to further evaluate Nexagon^® by randomly allocating (e.g., by the toss of a coin) 90 people with venous leg ulcers to Nexagon^® (one of two different doses) or a vehicle (substance containing no medication) to be applied to their ulcer three times over four weeks. Participants will be followed up for 12 weeks to evaluate ulcer healing.

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Study Title:	A Randomized, Double-Blind, Vehicle-Controlled, Parallel Group, Dose-Ranging, Multi-Center Study of the Efficacy and Safety of Nexagon® in the Treatment of Participants With Venous Leg Ulcers
Estimated Enrolment:	90
Intervention	Nexagon® Nexagon® vehicle
Phase	Phase II

clinicaltrials.gov

The NOVEL2 Study: A Study to Investigate the Efficacy, Safety and Tolerability of Nexagon^® as a Topical Treatment for Subjects with Venous Leg Ulcers
Study Completed.

Purpose

Venous leg ulcers are a common, costly and debilitating condition, with few effective treatments. Compression bandaging helps healing, but more than four out of every ten leg ulcers remain unhealed after three months. New treatments to help heal venous ulcers are urgently needed. Initial studies with a new drug product candidate called Nexagon^® (developed by CoDa Therapeutics, Inc.) have shown improvements in venous leg ulcer healing when applied topically to a wound. Following on from the successful NOVEL1 study, the NOVEL2 study will seek to confirm the efficacy, safety and tolerability of Nexagon^® as a treatment for venous leg ulcers. The study, which has a primary endpoint of change in venous ulcer surface area, will recruit 300 participants.s a primary endpoint of complete healing, will recruit 300 participants.

Study Type:	Interventional
Study Design:	Treatment Randomized, Parallel Group, Double Blind, Placebo and Standard Care Controlled, Efficacy and Safety Study
Study Title:	A Study to Investigate the Efficacy, Safety and Tolerability of Nexagon® as a Topical Treatment for Subjects with Venous Leg Ulcers (NOVEL2)
Estimated Enrolment:	300
Treatment Arms:	Nexagon® plus standard care Nexagon® vehicle plus standard care Standard care alone
Phase:	Phase II

clinicaltrials.gov