Company Plans to Meet with FDA to Discuss Filing Strategy for Approval
Izun Pharmaceuticals Corporation, a clinical stage company focused on developing high efficacy products based on botanical sources announced today that it has successfully completed a multicenter randomized, controlled trial comparing Curasite™, a topical pharmaceutical gel, to a matching active hydrogel placebo to treat diabetic foot ulcers. The study was conducted at seven centers in Israel in 82 patients.
The results of the study showed a steady and continuous improvement in wound healing over the four-week duration of the trial for the active arm. Curasite™ demonstrated greater than 54% wound closure at week four compared to baseline. The control group showed improvement at week one that plateaued at approximately 30% for the duration of the study. The improvement in wound healing in the active arm was significantly greater than that of the control arm at P< 0.05. Curasite™ accelerated wound healing and the trial demonstrated a clinically relevant effect size.
Moreover, control arm patients were given the opportunity to utilize Curasite™ in open label fashion for an additional month after the conclusion of the study. Those who chose to do so experienced incremental improvement in wound healing that approximated the 50% response rate results in wound healing seen in the active arm during the controlled study, thus validating the beneficial effect of Curasite™ in refractory wounds.
Jack Talley, Chief Executive Officer of Izun commented, “We are delighted with the outcome of this successful trial. Diabetic foot ulcers are a major medical problem that affects 6% of all diagnosed Type 2 diabetic patients annually. There is a significant unmet medical need in this area that we hope to fill. Based on our assessment of the data we intend to meet with the FDA for a presubmission meeting early next year.”
Dr. Jonathan Rosenblum, Director of the Diabetic Foot Service at Shaare Zedek Medical Center who participated as an investigator in the trial commented, “The Izun wound care gel has demonstrated excellent clinical efficacy in treating refractory wounds. The clinical benefits and ease of use could make this product a first line treatment for hard to heal wounds.”
The Company intends to meet with the FDA and other regulatory authorities to request guidance for a 510(k) or equivalent device filing with accompanying medical claims. Based on the outcome of these meetings, the company expects to be able to file for regulatory approval in 2016. Izun intends to make Curasite™ available for partnering in the United States, Europe and other territories.
About Diabetic Foot Ulcers
Diabetic foot ulcer (DFU) is a major complication of diabetes mellitus, and a major component of the diabetic foot.
Wound healing is an innate mechanism of action that works reliably most of the time. A key feature of wound healing is stepwise repair of lost extracellular matrix that forms the largest component of the dermal skin layer. In some cases, certain disorders or physiological insult disturbs the wound healing process. Diabetes mellitus is one such metabolic disorder that impedes the normal steps of the wound healing process. Many studies show a prolonged inflammatory phase in diabetic wounds, which causes a delay in the formation of mature granulation tissue and a parallel reduction in wound tensile strength.
Current treatment of diabetic foot ulcers includes: blood sugar control, removing dead tissue from the wound, dressings, and removing pressure from the wound through techniques such as total contact casting. Surgery in some cases may improve outcomes.
DFU occurs in 15% of people with diabetes, 6% of new patients annually and precedes 84% of all diabetes-related lower-leg amputations.