Biopharmaceutical company Edesa Biotech Inc (Nasdaq:EDSA) revealed on Thursday the receipt of the US Food and Drug Administration's "safe to proceed" letter for its Phase 2b clinical protocol of EB01 for the potential treatment of chronic allergic contact dermatitis (ACD).
The company is now authorised to proceed with its clinical investigation of EB01. It expects the first patient to be enrolled in the coming quarter following the manufacturing of its drug candidate.
EB01, a novel non-steroidal anti-inflammatory molecule (sPLA2 inhibitor), employs a novel mechanism of action against a common inflammation pathway. Unlike steroids and other anti-inflammatory drugs, the topical treatment being developed by the company is intended to inhibit the inflammatory process at its inception rather than after inflammation. In two previous clinical studies, EB01 has demonstrated significant improvement of multiple symptoms in contact dermatitis patients.
The protocol evaluates EB01 in a randomised, double-blind, vehicle-controlled, sample size adaptive design. ACD patients in this study will be treated for 28 days with various strengths of EB01 cream. Primary outcome measures will evaluate safety and efficacy. The company plans to complete an interim analysis following the enrolment 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.
Contact dermatitis, which can be either irritant contact dermatitis or ACD, is one of the most common occupational health illnesses in the US.
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