Edesa Biotech Inc (NASDAQ: EDSA) announced preliminary topline results from a Phase 2b study evaluating multiple concentrations of the company's drug candidate, EB01, as monotherapy for moderate-to-severe chronic Allergic Contact Dermatitis.
EB01 is a non-steroidal anti-inflamamatory compound that inhibits secretory phospholipase 2.
Edesa reported that 1.0% EB01 cream demonstrated statistically significant improvement over the placebo.
For the primary endpoint, patients with 1.0% EB01-treated lesions demonstrated a 60% average improvement in symptoms from baseline versus 39% for placebo/vehicle.
The effect was also observed at 15 days (44% for 1.0% EB01 vs. 29% for placebo) and continued at follow-up (64% for 1.0% EB01 vs. 44% for placebo).
For the 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. 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 the placebo.
The company expects to complete the Phase 2b data analysis by midyear.
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