Edesa Biotech's EB01 Shows Encouraging Interim Results In Dermatitis Trial

Edesa Biotech Inc's EDSA EB01 has met a key interim study parameter as part of an adaptive Phase 2b trial evaluating EB01 as monotherapy for moderate to severe chronic Allergic Contact Dermatitis (ACD).
Though blinded to treatment assignment, the study's Data and Safety Monitoring Board (DSMB) reported an approximately 1.7-fold difference between the treatment arms for the primary efficacy endpoint, which is the mean percent change from baseline on severity index at day 29.
Likewise, the DSMB reported an approximately 1.8-fold difference between the treatment arms in the proportion of patients achieving success on the ISGA (Investigator's Static Global Assessment), a key secondary efficacy endpoint.
No serious treatment-related adverse events were reported for either treatment group.
Based on these findings, the DSMB has recommended progression to the second cohort of patients.
Edesa will continue with an additional cohort of at least 120 evaluable subjects. The company is also evaluating a potential open-label extension for study patients.
EB01 cream contains a non-steroidal anti-inflammatory compound known as a sPLA2 (secretory phospholipase-2) inhibitor.
Price Action: EDSA shares are up 2.5% at $6.15 during the premarket session on the last check Thursday.