Benzinga | Jun 3, 2021 08:47AM EDT

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

* Edesa Biotech Inc's (NASDAQ: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.