BELLUS Health — Corporate Update (December 2021)
24 slides from BELLUS Health's corporate update, Dec 13, 2021
Slide 1: Phase 2b SOOTHE Trial in Refractory Chronic Cough Topline Results and P2X3 Pipeline Update
Phase 2b SOOTHE Trial in Refractory Chronic Cough Topline Results and P2X3 Pipeline Update DECEMBER 13 , 2021
Slide 2: Forward Looking Statements
Forward Looking Statements 2 Certain statements contained in this presentation, other than statements of fact that are independently verifiable at the date hereof, may constitute “forward - looking statements” within the meaning of Canadian securities legislation and regulations and other applicable
Slide 3: Positive SOOTHE Phase 2b trial in Refractory Chronic Cough
• Positive SOOTHE trial with primary efficacy endpoint statistically significant at 50 & 200 mg BID doses (p≤ 0.005) Efficacy x 34% placebo - adjusted reduction in 24 - hour cough frequency at 50 and 200 mg BID doses (p≤ 0.005) x 53% reduction from baseline in 24 - hour cough frequency at 50 and 200
Slide 4: BELLUS SOOTHE Phase 2b Topline Data
| ey) Bellus sooTHE Phase 2b Topline Data
Slide 5: SOOTHE Trial Design
SOOTHE Trial Design 5 Randomized, double - blind, 29 - day placebo - controlled parallel arm study with 3 active doses in 310 subjects PRIMARY ENDPOINT Placebo - adjusted change from baseline in 24H cough frequency (Day 28) MAIN POPULATION Refractory chronic cough for ≥1 year Screening / baseline aw
Slide 6: SOOTHE Baseline Characteristics
• Population randomized in SOOTHE was representative of RCC • Demographics and clinical characteristics were generally well - balanced across arms SOOTHE Baseline Characteristics 6 Main population Placebo BLU - 5937 (BID) 12.5 mg 50 mg 200 mg Number of subjects , n 63 62 62 62 Female , n (%) 49 (78%
Slide 7: SOOTHE Primary Efficacy Endpoint
SOOTHE Primary Efficacy Endpoint Placebo - Adjusted Change From Baseline in 24H Cough Frequency 7 Statistically significant and clinically meaningful reductions in placebo - adjusted change in 24 - hour cough frequency • Reductions over placebo of 34% at 50 and 200 mg BID doses Dose response observe
Slide 8: SOOTHE: Change From Baseline in 24H Cough Frequency
-60.0% -50.0% -40.0% -30.0% -20.0% -10.0% 0.0% Placebo 12.5 mg BID 50 mg BID 200 mg BID Relative change from baseline in 24H cough frequency Baseline Day 15 Day 28 SOOTHE: Change From Baseline in 24H Cough Frequency 8 Percentage change in 24H cough frequency Reduction in cough frequency from baselin
Slide 9: SOOTHE: Secondary Endpoints
SOOTHE: Secondary Endpoints Patient Reported Outcomes (PRO): Cough Severity Visual Analog Scale (CS - VAS) and Leicester Cough Questionnaire (LCQ) 9 x PROs demonstrate clinically meaningful and statistically significant benefit of BLU - 5937 at multiple time points x SOOTHE not powered to see statis
Slide 10: SOOTHE: Exploratory Population
SOOTHE: Exploratory Population 10 Exploratory analysis to generate additional data in a population with baseline cough frequency between 10 and 25 coughs/h • Not powered to observe a statistically significant response over placebo • 200 mg BID dose only Results in exploratory population: • No treatm
Slide 11: SOOTHE: Generally Well-Tolerated
SOOTHE: BLU - 5937 Generally Well - Tolerated 11 • Similar incidence of treatment emergent adverse events (TEAEs) reported for placebo and BLU - 5937 • No treatment emergent serious adverse events (TESAE) • Low incidence rate of taste disturbance adverse events (TDAEs) • One discontinuation on place
Slide 12: SOOTHE: Low Taste-Related Adverse Events
SOOTHE: Low Taste - Related Adverse Events Associated to P2X3 Class 12 • Low rate of taste disturbance adverse events at all doses (≤ 6.5%) • No complete or partial loss of taste at any dose • No severe taste disturbance adverse events • No discontinuations due to taste disturbance adverse events IN
Slide 13: Clinical Development Milestones and Planned Next Steps
December 13 , 2021 SOOTHE Topline results Clinical Development Milestones and Planned Next Steps 13 2020 2021 2022 2A: RELIEF 2B: SOOTHE Q2 2022 End of Phase 2 Meeting with FDA H2 2022 Start of Phase 3 program July 7, 2020 RELIEF Topline results
Slide 14: Preparation for Phase 3
Preparation for Phase 3 14 * Total across all human trials; over 450 subjects exposed to BLU - 5937 to - date SOOTHE final data to inform ongoing Phase 3 planning: • Dose selection • Population enrichment strategy • Key secondary endpoints • Mitigation of placebo effect Other Phase 3 Design Consider
Slide 15: Refractory Chronic Cough
Refractory Chronic Cough 15 Cough lasting ≥ 8 weeks that does not respond to treatment for underlying cause or is unexplained 1 No approved treatment , current options are inadequate and non - specific 3 Significant impact on patients ’ quality of life including impact on social, physical and psycho
Slide 16: SOOTHE: Summary
SOOTHE: Summary 16 SOOTHE Phase 2b top - line results, 50 mg BID dose Expected Phase 3 start in 34% decrease in placebo - adjusted 24H cough frequency 53% decrease in 24H cough frequency from baseline 6.5% No Dose - response observed rate of taste disturbance adverse events • Taste loss • Treatment
Slide 17: P2X3 Pipeline Update
ey) Bellus | P2X3 Pipeline Update
Slide 18: BLUEPRINT Phase 2a Trial in Chronic Pruritus Associated to Atopic Dermatitis
BLUEPRINT Phase 2a Trial in Chronic Pruritus Associated to Atopic Dermatitis 18 Randomized, double - blind, 4 - wk placebo - controlled parallel arm study comparing 200mg BID of BLU - 5937 to placebo in participants with chronic pruritus associated to atopic dermatitis BLUEPRINT Key takeaways • BLUE
Slide 19: Cough Hypersensitivity in Additional Cough Indications
Cough Hypersensitivity in Additional Cough Indications 19 Success of SOOTHE supports potential evaluation of BLU - 5937 in other cough populations Cough is an important health burden • Across the U.S. in 2018, cough was the reason for 1 : - 18.5M in - office physician consultations - 5M emergency vi
Slide 20: Conclusion
(wr) Bellus | Conclusion
Slide 21: BELLUS Today
BELLUS Today 21 Compelling SOOTHE Phase 2b topline data support potential best in class profile for BLU - 5937 and move into Phase 3 in refractory chronic cough Success of SOOTHE Phase 2b opens avenues for treating cough hypersensitivity in additional cough indications World class team focused on de
Slide 22: Closing Q&A Session
Closing Q&A Session 22 Prof. Jacky A. Smith, MB, ChB, FRCP, PhD University of Manchester, Principal Investigator of Phase 2b SOOTHE trial Roberto Bellini President & Chief Executive Officer Dr. Catherine Bonuccelli , MD Chief Medical Officer Dr. Denis Garceau Chief Scientific Officer Management Team
Slide 23: Appendix
(wr) Bellus _ Appendix
Slide 24: Analysis of Combined Taste-Related Adverse Events from Trials
Analysis of Combined Taste - Related Adverse Events from BLU - 5937 Trials 24 BID Dose Placebo 12.5 mg 25 mg 50 mg 100 mg 200 mg 400 mg 800 mg 1200 mg Participants reporting ≥1 TDAE 5/242 (2.1%) 3/68 (4.4%) 4/61 (6.6%) 12/205 (5.9%) 7/88 (8.0%) 23/303 (7.6%) 7/53 (13.2%) 5/8 (62.5%) 2/8 (25%) COMBIN