Business
Edesa Biotech Reports Topline Phase 2b Results for Dermatology Drug
Study successfully identified lowest effective dose1.0% formulation reached primary endpoint with statistical significanceCompany preparing for End of Phase 2
About this update from Edesa Biotech, Inc.
[{"type":"text","content":"Study successfully identified lowest effective dose1.0% formulation reached primary endpoint with statistical significanceCompany preparing for End of Phase 2 meeting with FDA following full analysisTORONTO, ON / ACCESSWIRE / January 17, 2023 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company focused on inflammatory and immune-related diseases, today announced preliminary, topline results from a Phase 2b clinical study evaluating multiple concentrations of the company's drug candidate, EB01, as a monotherapy for moderate-to-severe chronic Allergic Contact Dermatitis (ACD).The double-blind, placebo-controlled trial evaluated the safety and efficacy of EB01 in approximately 200 subjects, who were treated for 28 days with either EB01 cream (2.0%, 1.0% or 0.2%) or a placebo/vehicle cream. The primary efficacy outcome measurement was the mean percent improvement in symptoms from baseline at day 29 on the Contact Dermatitis Severity Index (CDSI). A key secondary efficacy measurement was the success rate of subjects achieving a score of \"clear\" or \"almost clear\" with at least a 2-point improvement from baseline after treatment at day 29 on the Investigator's Static Global Assessment (ISGA) scale.Edesa reported that 1.0% EB01 cream demonstrated statistically significant improvement over placebo. For the primary endpoint, patients with 1.0% EB01-treated lesions demonstrated a 60% average improvement in symptoms from baseline at day 29 on the CDSI versus 39% for placebo/vehicle (p=0.02). The effect was also observed at 15 days (44% for 1.0% EB01 vs 29% for placebo; p=0.05) and continued at follow-up (64% for 1.0% EB01 vs. 44% for placebo; p=0.04). For the ISGA secondary efficacy endpoint, 53% of patients with 1.0% EB01-treated lesions achieved a score of \"clear\" or \"almost clear\" with at least a 2-point improvement from baseline after treatment at day 29 (p=0.04). Only 29% of patients in the placebo group reached the same endpoint. No serious treatment-related adverse events were reported across all concentrations. The 2.0% and 0.2% formulations did not show significant differences compared to placebo (for detailed topline results, please see tables below).\"We are pleased that the study findings demonstrated that the 1.0% EB01 cream helped patients with moderate-to-severe disease significantly reduce ...