Gossamer Bio, Inc. · NASDAQ:GOSS
Gossamer Bio — Technical Presentation (October 2020)
23 slides from Gossamer Bio's technical presentation, Oct 13, 2020
Slide 1: GB001 Phase 2 Clinical Trial Topline Results
GB001 Phase 2 Clinical Trial Topline Results October 13, 2020 Exhibit 99.2
Slide 2: Forward-looking statements
This presentation contains forward-looking statements. All statements other than statements of historical facts contained in this presentation, including statements regarding the potential for the LEDA Study results to allow for the design of a well-powered Phase 3 program for GB001 and our plans to
Slide 3: A High Unmet Need Remains for Patients with Uncontrolled Severe Asthma
Datamonitor, open source medical claims, internal analysis. A High Unmet Need Remains for Patients with Uncontrolled Severe Asthma 1.2-1.5 mm Total Patients (US) ~85-90% ~10-15% Uncontrolled GINA 4/5 Patients With High Eos. Injectable biologics (Inc. Dupixent, Nucala, Xolair, and Fasenra) Uncontroll
Slide 4: GB001: Oral DP2 Antagonist for the Treatment of Severe Asthma
GB001 is a potent, insurmountable antagonist of the DP2 receptor DP2 antagonism has shown the potential to inhibit recruitment of airway eosinophils and reduce airway inflammation GB001 exhibits prolonged receptor residence time and extended pharmacodynamic effects Previously demonstrated clinical e
Slide 5: Phase 2b LEDA Study Design and Overview
Phase 2b LEDA Study Design and Overview QD = once daily dosing; wks = weeks; SOC = standard of care; ICS = inhaled corticosteroids; AM PEF = morning peak expiratory flow; FEV1 = forced expiratory volume in 1 second. Run-in Treatment Period Follow-up 4 wks 24 wks Consent Randomization 4 wks Placebo Q
Slide 6: Goals for LEDA Study
Evaluate whether once-daily, oral GB001 has a clinically meaningful impact on efficacy outcomes relevant to anti-inflammatory mechanism (asthma worsening and severe exacerbation) to inform effects and statistical powering on potential registrational Phase 3 endpoints Dose-range to understand effect
Slide 7: Definition of the LEDA Primary Efficacy Endpoint
Definition of the LEDA Primary Efficacy Endpoint: Proportion of Patients Experiencing Asthma Worsening by Week 24 Asthma worsening defined as a patient meeting ANY one of the following 5 components at ANY time by Week 24: AM PEF ≤ 75% of mean baseline AM PEF on 2 consecutive days FEV1 < 80% of basel
Slide 8: Baseline Characteristics in Phase 2b LEDA Study
Baseline Characteristics in Phase 2b LEDA Study Characteristic Overall Population (N=480) Age – mean (SD) 51.8 (12.92) Female, n (%) 308 (64.2) ICS High, n (%) 287 (59.8) Asthma Duration (years) – mean (SD) 20.566 (14.312) Number of exacerbations in last 12 months – mean (SD) 1.7 (1.11) 2 or more ex
Slide 9: Summary of Phase 2b LEDA Primary and Secondary Endpoints
Summary of Phase 2b LEDA Primary and Secondary Endpoints GB001 groups did not meet the primary endpoint of proportion of patients who experience asthma worsening by week 24 However, consistent numeric reductions in the odds of asthma worsening of 32% to 35% observed (p-values: 0.1086 to 0.1482) acro
Slide 10: LEDA Primary Endpoint: Proportion with Asthma Worsening by Week 24
LEDA Primary Endpoint: Proportion of Patients who Experience Asthma Worsening by Week 24 GB001 Achieved Consistent Numeric Reductions on Primary Endpoint OR = odds ratio 32.6% Reduction OR = 0.674 32.3% Reduction OR = 0.677 34.9% Reduction OR = 0.651
Slide 11: LEDA Key Secondary Endpoint: Time to First Asthma Worsening
LEDA Key Secondary Endpoint: Time to First Asthma Worsening GB001 20 mg & 60 mg significantly improved time to first asthma worsening HR = Hazard Ratio 20 mg: HR=0.719, Reduction=28.1%, p=0.0466 40 mg: HR=0.773, Reduction=22.7%, p=0.1222 60 mg: HR=0.698, Reduction=30.2%, p=0.0304 GB001 vs Placebo
Slide 12: Primary Endpoint with Post-Hoc Pooled GB001 Analysis
LEDA Primary Endpoint: Proportion of Patients who Experience Asthma Worsening by Week 24 OR = odds ratio. 32.6% Reduction OR = 0.674 32.3% Reduction OR = 0.677 34.9% Reduction OR = 0.651 Pooled Analysis of GB001 treatment groups approaches statistical significance Post-Hoc Pooled GB001 Analysis Prim
Slide 13: Post Hoc Analysis: Proportion with Severe Asthma Worsening
GB001 significantly reduced the proportion of patients with severe asthma worsening, defined as meeting ≥ 3 components of the primary endpoint LEDA Post Hoc Analysis: Proportion of Patients who Experience Severe Asthma Worsening by Week 24 72.1% Reduction OR = 0.279 87.7% Reduction OR = 0.123 81.0%
Slide 14: LEDA Secondary Endpoint: Annualized Severe Asthma Exacerbation Rate
LEDA Secondary Endpoint: Annualized Severe Asthma Exacerbation Rate (AER) 20.3% Reduction RR = 0.797 25.2% Reduction RR = 0.748 11.1% Reduction RR = 0.889 Although 24-Week Study Not Powered for This Endpoint, Numeric Reductions on AER Observed RR = rate ratio
Slide 15: LEDA Post Hoc Analysis: AER in Selected Patient Subgroup
LEDA Post Hoc Analysis: AER in Selected Patient Subgroup 38.7% Reduction RR = 0.613 35.5% Reduction RR = 0.645 29.6% Reduction RR = 0.704 Preliminary identification of a patient subgroup has potential to enrich patient selection and enhance treatment response Comparison to Overall Population % Reduc
Slide 16: Summary of LEDA Safety Profile
Incidence of adverse events was generally comparable across treatment groups: 65.8% Placebo, 65.8% GB001 20 mg, 69.5% GB001 40 mg, 68.0% GB001 60 mg Adverse events of interest (liver chemistry elevations leading to study drug discontinuation) occurred more frequently in GB001 60 mg (4.1%, n=5) than
Slide 17: LEDA Incidence of Adverse Events by Preferred Term
LEDA Incidence of Adverse Events by Preferred Term 5% or Greater in Any Group Preferred Term – n (%) Placebo (N=120) GB001 20 mg (N=120) GB001 40 mg (N=118) GB001 60 mg (N=122) Total GB001 (N=360) Number of patients with an Adverse Event 79 (65.8) 79 (65.8) 82 (69.5) 83 (68.0) 244 (67.8) Nasopharyng
Slide 18: Summary of Phase 2b LEDA Results
Summary of Phase 2b LEDA Results GB001 groups did not meet the primary endpoint of proportion of patients who experience asthma worsening by week 24 However, consistent numeric reductions in the odds of asthma worsening of 32% to 35% observed (p-values: 0.1086 to 0.1482) across GB001 groups GB001 20
Slide 19: Market Research Suggests GB001's Target Profile is Compelling for an Oral Therapy
Market Research Suggests GB001’s Target Profile is Compelling for an Oral Therapy Exacerbation Data Was Viewed at the Most Important Measure of Efficacy in Moderate-to-Severe Asthma Clinical Trials1 Efficacy Threshold for Surveyed Physicians to Find an Oral Asthma Therapeutic to be Compelling2 20-30
Slide 20: TITAN Phase 2 Study in Chronic Rhinosinusitis – Topline Results
TITAN Phase 2 Study in Chronic Rhinosinusitis – Topline Results TITAN: 16-week, Phase 2 study in patients with chronic rhinosinusitis (CRS), both with and without polyps, randomized 97 patients to GB001 40 mg or placebo Study failed to meet primary endpoint of change from baseline in SNOT-22 score a
Slide 21: Next Steps
Next Steps LEDA Phase 2b suggests potential of oral DP2 pathway inhibition for the treatment of patients with uncontrolled severe asthma Gossamer will discuss these results and next steps for clinical development with global regulatory authorities and continue partnering discussions Full results fro
Slide 22: Robust Pipeline with Four Clinical-Stage Product Candidates
Robust Pipeline with Four Clinical-Stage Product Candidates PROGRAM CLASS (Route of Admin.) INDICATION RESEARCH PRE-CLINICAL PHASE 1 PHASE 2 PHASE 3 RIGHTS GB001 DP2 Antagonist (Oral) Moderate-to-Severe Eosinophilic Asthma Worldwide (except Japan) GB001 DP2 Antagonist (Oral) Chronic Rhinosinusitis (
Slide 23: Thank you to all patients, caregivers, investigators, and employees
Thank you to all patients, caregivers, investigators, and Gossamer employees who participated in and contributed to these studies!