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. Two Phase 2 studies are underway to investigate the use of Nexagon^® in the treatment of venous leg ulcers and diabetic foot ulcers.  Additional clinical studies are underway or scheduled to be initiated in 2009, including studies for treatment of inflammatory leg ulcers, ocular persistent epithelial defects and corneal trauma. Successful completion of Phase 2 studies will position the company to advance to registration studies.

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 ASCEND Study: A Study to Investigate the Safety and Clinical Effect of Nexagon^® to Treat Slow Healing Diabetic Foot Ulcers

Study Completed.

Purpose

Diabetic foot ulcers are sores on the feet that occur in 15% of diabetic patients some time during their lifetime. Once an ulcer develops, the risk of lower-extremity amputation is increased 8-fold in people with diabetes. New treatments that improve the number of ulcers that heal and/or speed up healing are urgently needed. Initial studies with a new drug called Nexagon^® (developed by CoDa Therapeutics, Inc.) support the concept that healing of diabetic foot ulcers can be improved with topical application of Nexagon^®. Further research will be undertaken to assess the safety and activity of Nexagon^® when applied to diabetic foot ulcers at various doses. A proposed randomized controlled trial will randomly allocate (e.g., by the toss of a coin) 24 people with diabetic foot ulcers to Nexagon^® (one of three different doses) or vehicle (substance containing no medication) to be applied to their ulcer three times over four weeks. Participants will be followed over four weeks to monitor their response to the treatment, specifically with regards to the amount of healing that occurs.

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Study Title:	A Randomized, Prospective, Double-Blind, Vehicle-Controlled, Dose-Escalation, Single-Centre Study of the Safety and Clinical Effect of Nexagon® in the Treatment of Participants With Diabetic Foot Ulcers
Estimated Enrolment:	24
Diabetic Foot Ulcer:	Drug: Nexagon® Drug: Nexagon® vehicle
Phase:	Phase I/II

clinicaltrials.gov