Benzinga | Nov 3, 2020 07:27AM EST

Edesa Biotech Achieves Enrollment Milestone In Dermatitis Study

TORONTO, ON / ACCESSWIRE / November 3, 2020 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company, today announced that it has completed enrollment of more than 50% of the patients planned for the first cohort of a Phase 2b clinical study evaluating the company's drug candidate as a monotherapy for chronic allergic contact dermatitis.

The adaptive, double-blind study is evaluating the safety and efficacy of EB01 cream in approximately 46 subjects in the first cohort. EB01 is an investigational medicine that contains a non-steroidal anti-inflammatory compound known as an sPLA2 inhibitor. In two previous clinical studies EB01 has demonstrated statistically significant improvement of multiple symptoms in ACD patients.

Dr. Par Nijhawan, Chief Executive Officer of Edesa, said that the company plans to perform a blinded interim analysis following the completion of the first cohort. This adaptive protocol design is intended to make the study more flexible and efficient, and will determine the total number of patients for the second part of the study.

"The patient recruitment rate for our EB01 Phase 2b study in the context of the pandemic is very encouraging. We have now passed the halfway mark for the first cohort and look forward to the trial continuing to progress toward the interim analysis," said Dr. Nijhawan. "We are grateful to the physicians, research staff and participating patients for enabling us to reach this important milestone and encouraged by the interest expressed by the dermatology community for the non-steroidal novel mechanism employed by EB01."

Contact dermatitis, which can be either irritant contact dermatitis or ACD, is one of the most common occupational health illnesses in the United States. The disease has been estimated to cost up to $2 billion annually as a result of lost work, reduced productivity, medical care and disability payments. Edesa estimates that there are more than 2.5 million people in the U.S. with allergic contact dermatitis, with academic literature pointing to a potentially larger undiagnosed population. More than one million patients are estimated to have chronic ACD. To the company's knowledge there are currently no treatment options specifically labelled for ACD.

Additional details about the Phase 2b trial of EB01 (NCT03680131) can be found at www.clinicaltrials.gov.