Edesa Biotech (EDSA) Reports Final Phase 2b Results for Dermatitis Study

November 20, 2023 4:08 PM EST

Edesa Biotech, Inc. (NASDAQ: EDSA), a clinical-stage biopharmaceutical company focused on inflammatory and immune-related diseases, today 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).

"We are thrilled to announce the positive final clinical study results for 1.0% EB01 cream, which not only confirm our previous data but also provided important new insights into the efficacy of our first-in-class drug candidate," said Par Nijhawan, MD, Chief Executive Officer of Edesa Biotech. "This significant milestone puts us in position to advance potential partnership discussions and ultimately brings us one step closer to delivering potentially life-changing solutions to patients with moderate to severe, chronic allergic contact dermatitis."

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