Company: EDSA
Filing Date: 2025-10-28
Form Type: 8-K
Source: 0001171843-25-006690
Chunk: 1

Company: Edesa Biotech, Inc.
Filing Date: 2025-10-28
Form: 8-K
Item: Item 8.01
Chunk 1
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38 hospitals in the USA, Canada and Colombia. Participants were 18 years or older, receiving IMV with or without additional organ support at the time of hospitalization. They were randomly assigned (1:1) to SOC with paridiprubart (15mg/kg, maximum dose of 1400mg, n=56), or SOC with placebo (n=48). Efficacy outcomes were 28-day and 60-day mortality and proportion of patients with a decrease of ≥ 2 points in the WHO COVID-19 Severity Scale (WCSS) at 28-days. As previously disclosed, the Company opted to discontinue enrollment early for business reasons.

Patient demographics and baseline disease parameters were similar for the two groups with overall mean (SD) age: 52 (20-86) years, female (34%), severe ARDS (55%); moderate ARDS (38%); mild ARDS (5%), antivirals (10%), corticosteroids (44%), immunomodulators (10%), IMV only (36%), IMV with additional organ support (64%), acute kidney injury (26%), sepsis (20%), pneumonia (40%).

The following tables summarize the key results from the truncated Phase 3 study.

Mortality Rate at 28 Days and 60 Days

Multivariate Logistic Regression Derived Risk Differences, 95%CI*

  Timepoint                                                                                                                                                                                                 Paridiprubart          Placebo                P-Value**  
  28-Day                                                                                                                                                                                                    0.39 (0.35, 0.44)      0.52 (0.47, 0.58)      <0.001     
  60-Day                                                                                                                                                                                                    0.46 (0.42, 0.50)      0.59 (0.55, 0.63)      0.003      
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  Adjusted mortality risk estimate: variables included age, baseline WCSS, baseline antiviral use, baseline corticosteroid use, baseline immunomodulator use, concomitant antiviral use, concomitan...                                                               

Achievement of ≥2-Point Improvement in WCSS at 28 Days

Multivariate Logistic Regression Derived Risk Differences, 95%CI*

  Paridiprubart                                                                                                                                                                                             Placebo                P-Value**  
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