The US Food and Drug Administration notified the biopharmaceutical company that it may proceed with its clinical investigation of EB101, which Edesa is developing as a treatment for chronic allergic contact dermatitis.
Based in Toronto, Edesa’s shares doubled to US$8.57 on Thursday at the midday point of New York trading.
Unlike other treatments such as steroid and anti-inflammatory drugs, EB101 is a topical treatment designed to halt the inflammatory process when it begins, rather than after it has occurred. Previous studies have demonstrated significant improvement of symptoms using EB101, according to Edesa.
The “safe to proceed” letter from the US FDA formally approves Edesa’s Phase 2b clinical protocol and authorizes the company to begin clinical investigation.
"There are limited options for ACD patients and we have been pleased with the level of interest from physicians in the US," said Dr Par Nijhawan, CEO of Edesa. "The company is committed to rapidly advancing our clinical plans and remains on track to initiate our clinical study for EB01."
The company also has offices in southern California.
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