Business
Edesa Biotech Reports Phase 2b Study Reaches Full Enrollment
Primary Endpoint To Be Reached Within 30 Days, With Topline Data Available by End of YearCompany Evaluating Partnership and Out-Licensing Opportunities
About this update from Edesa Biotech, Inc.
[{"type":"text","content":"Primary Endpoint To Be Reached Within 30 Days, With Topline Data Available by End of YearCompany Evaluating Partnership and Out-Licensing Opportunities Outside North America for Its First-in-Class, Anti-Inflammatory Drug CandidateTORONTO, ON / ACCESSWIRE / September 7, 2022 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company focused on inflammatory and immune-related diseases, today announced that patient recruitment has been completed for a Phase 2b clinical study evaluating the company's drug candidate, designated EB01, as a monotherapy for moderate-to-severe chronic Allergic Contact Dermatitis (ACD). EB01 represents a potentially new class of non-steroidal, anti-inflammatory treatment for this often-debilitating occupational disease.All the remaining subjects are expected to complete the primary treatment period within the next 30 days, and Edesa anticipates that topline data will be available by the end of the year.Par Nijhawan, MD, Chief Executive Officer of Edesa, said that encouraging interim data as well as the robust pace of enrollment are driving the company's excitement regarding the upcoming readout.\"We are pleased to have completed enrollment ahead of schedule, and we are especially grateful to the patients, physicians and research staff for enabling us to reach this important milestone. EB01 represents a potentially powerful new way to manage inflammation, even in severe cases, without the safety concerns and side effects of topical corticosteroids. This is especially important for patients with chronic lesions and inflammation,\" said Dr. Nijhawan.Edesa reported that while topline and final study results are pending and subject to regulatory review, the company is advancing its commercialization strategy for its EB01 drug candidate. This includes preparing trial design and regulatory filings, prioritizing potential add-on or adjacent disease indications for future studies, and exploring potential commercialization partners.\"Outside our primary target markets in North America, we plan to evaluate strategic licensing or partnering arrangements with pharmaceutical companies for the further development or commercialization of EB01, such as in areas where a partner may contribute additional resources, infrastructure and expertise,\" Dr. Nijhawan said.EB01 is a topical vanishing cream that ...