Edesa Biotech (NASDAQ:EDSA) stock is flying higher on Thursday after getting approval from the U.S. Food and Drug Administration (FDA).
The approval from the FDA is for Edesa Biotech to move forward with a study of EB01. This is a novel sPLA2 inhibitor that the company is working on. It hopes to use it to treat chronic allergic contact dermatitis.
According to Edesa Biotech, this approval will allow it to start a Phase 2b clinical protocol and clinical investigation into the drug. The company says that it is planning to enroll the first patient in the study starting sometime next quarter.
“There are limited options for ACD patients and we have been pleased with the level of interest from physicians in the U.S.,” Dr. Par Nijhawan, CEO of Edesa Biotech, said in a statement. “The company is committed to rapidly advancing our clinical plans and remains on track to initiate our clinical study for EB01.”
Edesa Biotech says that it will be performing a randomized, double-blind, vehicle-controlled, sample size adaptive design study of the drug’s ability to treat chronic allergic contact dermatitis. This will have patients using various EB01 creams with different strengths over a 28-day period. It also points out that the study may include up to 166 patients.
EDSA stock was up 115% as of noon Thursday, but is down 26% since the start of the year.
As of this writing, William White did not hold a position in any of the aforementioned securities.