Edesa Biotech, Inc. announced favorable final results from a Phase 2b dose-ranging clinical study of the company's drug candidate, EB01 (daniluromer), as a monotherapy for moderate-to-severe chronic Allergic Contact Dermatitis (ACD). Edesa reported that final data confirmed previous topline findings 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 Contact Dermatitis Severity Index (CDSI) versus 40% for placebo/vehicle (p=0.027).

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=0.048). Only 29% of patients in the placebo group reached the same endpoint. For other dose formulations, no material changes to previously reported topline efficacy results were identified.

No serious treatment-related adverse events were reported across all dose formulations. In addition, analysis of the full dataset demonstrated that patients receiving 1.0% EB01 (daniluromer) experienced improvement across each component symptom of the CDSI score, including redness (50% reduction for EB01 vs. 35.4% placebo; p=0.17), pruritis/itching (60.5% reduction for EB01 vs.

41.3% placebo; p=0.06), fissures (63.1% reduction for EB01 vs. 44.3% placebo; p=0.02), scaling (58.3% reduction for EB01 vs. 42.9% placebo; p=0.36), and dryness (62.9% reduction for EB01 vs.

35.9% placebo; p=0.02). The final data also demonstrated that the Body Surface Area (BSA) of 1.0% EB01-treated lesions was reduced by 42.1% on average at day 29 compared to a 8.8% reduction for placebo/vehicle (p=0.054).