Slide 1: Phase 3 Study of Paridiprubart in Patients on Invasive Mechanical Ventilation
A Phase 3, Multicenter, Double-blind, Placebo Controlled Study of an Anti-TLR4 Antibody, Paridiprubart, in Adult Patients With Respiratory Distress on Invasive Mechanical Ventilation Dr. Ted Steiner University of British Columbia
Slide 2: Disclosure to Learners
Disclosure to Learners Financial Relationships with “ineligible companies” within the past 24 months: • Edesa Biotech, Inc. – Consultant, travel support
Slide 3: TLR4 Activation and Critical Illnesses
TLR4 Activation and Critical Illnesses Multiple insults can lead to ARDS through TLR4 activation—Most critically ill patients are managed similarly Inducing Agent/Insult Bacterial (e.g. gram-negative) Host • Acute Respiratory Viral Damage Distress Syndrome • Acute Kidney injury Death (e.g. Influenza
Slide 4: Overview of Paridiprubart – Initial focus on ARDS
Overview of Paridiprubart – Initial focus on ARDS Paridiprubart is an anti-TLR4 monoclonal antibody that dampens the dysregulated immune response in ARDS Without paridiprubart With paridiprubart TLR4 activation leads to dimerization and Paridiprubart triggering of inflammatory pathway Paridiprubart
Slide 5: Phase 3 Study Design
Phase 3 Study Design Intent to treat population comprised of 104 patients on IMV ITT Population (IMV with or without ECMO/Organ Support) Key Inclusion Criteria • Men and women >18 years old Paridiprubart + SOC (N=56) • Positive COVID-19 test • Negative pregnancy test N=104 • IMV Placebo + SOC (N=48)
Slide 6: Phase 3 Baseline Characteristics
Phase 3 Baseline Characteristics Intent to treat population comprised of 104 patients on IMV Average Age ARDS Severity Clinical Severity 5% (N=5) 52.2 IMV 36% IMV with Moderate Severe 38% 55% Only (N=37) ECMO/ (STD=14.7) (N=40) (N=57) 64% Organ (N=67) support Paridiprubart Placebo Total N % N % N %
Slide 7: Phase 3 Results – Primary Endpoint 28-Day Mortality
Phase 3 Results – Primary Endpoint 28-Day Mortality Paridiprubart Met Primary and Secondary Endpoints with Statistical Significance Mortality at Day 28* Mortality at Day 60* Summary of Phase 3 Results n=104 n=104 P Value <0.001 P Value =0.003 28-Day Mortality Rate: Paridiprubart had a relative reduc
Slide 8: Paridiprubart Treatment Had Significant Impact on Clinical Improvement
Paridiprubart Treatment Had Significant Impact on Clinical Improvement Treatment Nearly Doubled the Chance of Recovery by Day 28 - ITT Estimated Proportion Achieving Secondary Endpoint a 2-pt Reduction in WHO Scale (p=0.032) Proportion of Patients Who Achieved at Least a 2-Point Reduction in the WHO
Slide 9: Safety Assessment
Safety Assessment Paridiprubart exhibits a favorable safety profile • Safety population for the phase 3 study consisted of 278 patients (138 with EB05 and 140 with placebo). • A total of 464 patients and healthy volunteers have been dosed with paridiprubart over the course of its development history
Slide 10: Conclusions
Conclusions As a result of the phase 3 study, Paridiprubart has demonstrated: Success in meeting primary & secondary endpoints with statistically significant reductions in 28- and 60-day mortality. Improved clinical recovery: higher rate of 2-point WHO improvement and earlier liberation from IMV