Edesa Biotech reported that the U.S. FDA has notified the company that it may proceed with its clinical investigation of EB01 under development as a potential treatment for chronic allergic contact dermatitis. The FDA “safe to proceed” letter formally approves the company’s Phase 2b clinical protocol and authorizes the company to begin its clinical investigation.
The phase 2b trial is a randomized, double-blind, vehicle-controlled, sample size adaptive design in patients with allergic contact dermatitis. The patients will be treated for 28 days with various strengths of EB01 cream. Primary outcome measures will evaluate safety and efficacy. Secondary and exploratory measures will evaluate symptom reduction, quality of life and dose-relationships among various strengths of EB01 cream. The company plans to complete an interim analysis following the enrollment of the first cohort to determine the total sample size in the second part of the study; up to 166 total patients may be enrolled. Edesa expects the first patient to be enrolled in the coming quarter following the manufacturing of its drug candidate.
EB01 employs a novel mechanism of action against a common inflammation pathway. Unlike steroids and other anti-inflammatory drugs, the topical treatment being developed by Edesa is intended to inhibit the inflammatory process at its inception rather than after inflammation has occurred. In two previous clinical studies, EB01 has demonstrated significant improvement of multiple symptoms in contact dermatitis patients.
About Allergic Contact Dermatitis (ACD)
Contact dermatitis, which can be either irritant contact dermatitis or ACD, is one of the most common occupational health illnesses in the United States, and has been estimated to cost $2 billion annually as a result of lost work, reduced productivity, medical care and disability payments. Edesa Biotech estimates that there are more than 13.2 million people in the U.S. with contact dermatitis, with between 20% and 60% of all cases diagnosed as ACD. Approximately 1.2 million patients have chronic ACD. There are no treatment options specifically indicated for ACD and physicians must utilize agents approved for other dermatology conditions, such as topical corticosteroids, which are able to manage disease symptoms in less than half of patients and have well-known side-effects.