Edesa Biotech (NASDAQ:EDSA) gets the go-ahead from the U.S. Food and Drug Administration for its clinical investigation of EB01, a sPLA2 inhibitor, which Edesa is developing 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.
Edesa expects the first patient to be enrolled in the coming quarter after the manufacturing of its drug candidate.
Unlike steroids and other anti-inflammatory drugs, like ibuprofen, 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.
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