Slide 1: Clinical benefit of oral sabizabulin for hospitalized adults with covid-19 on supplemental oxygen
Clinical benefit of oral sabizabulin for hospitalized adults with covid-19 on supplemental oxygen Paula Skarda, MD – Internal Medicine/Pediatrics Regions Hospital, St. Paul, Minnesota Sabizabulin has not been granted Emergency Use Authorization (EUA) or U.S. Food and Drug Administration (FDA) approv
Slide 2: Forward looking statements
Forward looking statements The statements in this release that are not historical facts are “forward-looking statements” as that term is defined in the Private Securities Litigation Reform Act of 1995. Forward-looking statements in this release include statements regarding: whether and when the Comp
Slide 3: Disclosures- Paula Skarda, MD
Disclosures- Paula Skarda, MD Principle Investigator • Phase 3, Randomized, Placebo-Controlled, Efficacy and Safety Study of VERU-111 for the Treatment of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) in Patients at High Risk for Acute Respiratory Distress Syndrome (ARDS) -Veru, Inc o
Slide 4: Veru requested emergency use authorization
Veru requested emergency use authorization Sabizabulin Sabizaulin is not a U.S. Food and Drug Administration (FDA) approved product and at this time sabizabulin has not been granted FDA Emergency Use Authorization (EUA). Requested In clinical trials, sabizabulin was studied for treatment of SARS-CoV
Slide 5: Sabizabulin targets microtubules to halt viral infection and suppress aberrant immune response
Sabizabulin targets microtubules to halt viral infection as well as suppresses the aberrant antiviral immune response that can lead to cytokine storm 9,10 Viral Infection Immune Response Sabizabulin, a microtubule disruptor, has dual antiviral and anti-inflammatory activities • SARS-CoV-2 utilizes h
Slide 6: Interim analysis of Phase 3 trial: 55.2% relative reduction in mortality
In the interim analysis of a Phase 3 clinical trial sabizabulin treatment resulted in a 55.2% relative reduction in mortality compared to placebo1 Trial Design • Randomized, multicenter placebo-controlled Phase 3 clinical trial was conducted in hospitalized moderate-severe COVID-19 patients at high-
Slide 7: Interim analysis of Phase 3 trial: outcomes and safety
In the interim analysis of a Phase 3 clinical trial sabizabulin treatment resulted in a 55.2% relative reduction in mortality compared to placebo1 Outcomes1-2 • In a planned interim analysis, sabizabulin treatment resulted in a 55.2% relative reduction in mortality at Day 60 compared to placebo. • A
Slide 8: Methods
Methods A total of 88 patients classified as WHO 4 with a baseline comorbidity underwent randomization (59 sabizabulin/29 placebo) • Analysis population • Patients classified as WHO 4 with at least one comorbidity (Asthma, Chronic Lung Disease, Diabetes, Hypertension, Severe Obesity (BMI ≥40), >65 y
Slide 9: Patient demographics
Patient demographics Demographics WHO 4 (subjects for whom vitals status is known) Sabizabulin (n=58) Placebo (n=29) 65.8±10.5 69.0±7.49 Age (yrs) (40,92) (52,86) 31.0±6.52 30.3±5.82 BMI (kg/m2) (19.1,48.8) (22.6,48.4) SpO2 at baseline (day 1) 91.0±3.81 91.0±3.08 (%) (82,99) (84,99) Vaccinated 31.0%
Slide 10: Sabizabulin treatment resulted in an 81.2% reduction in mortality vs placebo in WHO 4
Sabizabulin treatment resulted in an 81.2% reduction in mortality vs placebo in WHO 4 subjects at day 60 Key Primary End Point Result Sabizabulin 9mg (N=59) Placebo (N=29) • At day 60, sabizabulin resulted in: • 22.4% absolute reduction in deaths vs placebo Alive 55 (94.8) 21 (72.4) • 81.2% relative
Slide 11: Reductions in hospital length of stay, ICU days and mechanical ventilation days
Sabizabulin treatment resulted in statistically significant reductions in hospital length of stay, ICU days and mechanical ventilation days vs placebo Key secondary endpoints Days in Hospital Treatment Mean (days)1 SD Median (days) Min,Max • Sabizabulin treatment vs placebo Sabizabulin 9 mg 14.2 13.
Slide 12: Conclusions
Conclusions • Sabizabulin, a dual antiviral and anti-inflammatory agent, significantly reduced deaths in hospitalized moderate to severe COVID-19 WHO 4 patients with at least one comorbidity • Sabizabulin showed statistically significant reductions in key secondary endpoints: days in hospital, days
Slide 13: Acknowledgements
Acknowledgements We would like to thank all of the investigators that participated in the global Phase 3 covid-19 sabizabulin study Sabizabulin has not been granted Emergency Use Authorization (EUA) or U.S. Food and Drug Administration (FDA) approval. The safety and efficacy of sabizabulin has not b