BELLUS Health — Corporate Update (July 2022)
10 slides from BELLUS Health's corporate update, Jul 12, 2022
Slide 1: BLU-5937 for Refractory Chronic Cough: Positive FDA End of Phase 2 Meeting and CALM Phase 3 Program Design
BLU - 5937 for Refractory Chronic Cough: Positive FDA End of Phase 2 Meeting and its CALM Phase 3 Program Design JULY 12, 2022
Slide 2: Forward Looking Statements
Forward Looking Statements 1 Certain statements contained in this presentation, other than statements of fact that are independently verifiable at the dat e h ereof, may constitute "forward - looking statements" within the meaning of Canadian securities legislation and regulations, the U.S. Private
Slide 3: Positive FDA End-of-Phase 2 Meeting and Announcing CALM Phase 3 Program
Positive FDA End - of - Phase 2 Meeting and Announcing CALM Phase 3 Program • CALM Phase 3 Program designed to support approval of BLU - 5937 for treatment of refractory chronic cough (RCC): x Two pivotal Phase 3 trials, CALM - 1 and CALM - 2, with 3 expected arms: 25mg, 50mg and placebo BID x Prima
Slide 4: CALM Program: Study Design
CALM Program: Study Design Two randomized, double - blind, placebo - controlled parallel arm trials with 2 active doses POPULATION • Refractory/unexplained chronic cough • Cough ≥1 year • Enriched for baseline cough frequency • CALM - 1 and CALM - 2: ∼ 675 participants each PRIMARY EFFICACY ENDPOINT
Slide 5: CALM Program: Enrichment Strategy
CALM Program: Enrichment Strategy CALM - 1 and CALM - 2 populations to be enriched for baseline cough frequency PRIMARY EFFICACY ENDPOINT: COUGH FREQUENCY IN PRIMARY POPULATION (90% POWER) • 24H cough frequency vs placebo in Primary Population SECONDARY EFFICACY ENDPOINTS (80% POWER) • Leicester Cou
Slide 6: Phase 3: Dose Selection
CALM Phase 3: Dose Selection Well supported clinical rationale for 25 and 50mg BID dose selection: • No dose response observed between 25 and 200mg BID in RELIEF Ph2a study • 50mg BID lowest optimal dose in SOOTHE Phase 2b study • 50 and 200mg BID achieved 34% placebo - adjusted reduction in cough f
Slide 7: Statistical Methodology: Negative Binomial Analysis
• Statistical consultants recommended and FDA was aligned with using the negative binomial (NB) statistical method to analyze cough count data in CALM Phase 3 Program • NB expected to have a better statistical fit for count data like cough frequency • Previous method of log - transformation of cough
Slide 8: VitaloJAK Cough Monitoring System
• VitaloJAK is the cough recording and counting system used to capture the 24H cough frequency data in most cough trials • Used in BLU - 5937 and gefapixant RCC trials • Will be used in the CALM Phase 3 program • The Company and FDA aligned on validation of VitaloJAK cough frequency measurement to s
Slide 9: Phase 3: Clinical Development Milestones and Expected Next Steps
CALM Phase 3: Clinical Development Milestones and Expected Next Steps Topline results from CALM - 1 Phase 3 trial expected in 2H 2024 9 December 13 , 2021 SOOTHE Phase 2b Topline Results 2H 2021 2022 PH 2B June 2022 End - of - Phase 2 Meeting with FDA 4Q 2022 Expected First Patient Enrolled in Phase
Slide 10: BELLUS Today
10 Potential BLU - 5937 best - in - class profile for the treatment of refractory chronic cough, a large and growing market with limited competition BELLUS Today Potential for building pipeline targeting cough hypersensitivity in additional cough indications World - class team focused on delivering