The company said that patient screening and enrollment for the first of two human trials designed to determine the safety pharmacokinetics of QR-333 will begin immediately. A phase IIb dose ranging study will then commence after the completion of the pharmacokinetic study.
“We are anxious to start clinical trials for QR-333 within the FDA investigational new drug (IND) program,” said Dr Richard Rosenbloom, COO and executive vice president of Quigley Pharma. “The granting of this IND number is a significant milestone for this company and the result of a significant coordinated effort.”
The original proof of concept study, completed in France, showed that the topical compound improved the quality of life as well as improved key symptoms associated with this complication of diabetes. The subjects using the compound had 67% of their symptoms improve, suggesting efficacy. QR-333 has since been evaluated in animal model toxicity experiments previous to the FDA granting this IND.