Insmed Incorporated · NASDAQ:INSM

Insmed — 7th World Bronchiectasis Conference (July 2024)

22 slides from Insmed's conference presentation, Jul 3, 2024

  1. Slide 1: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study: The ASPEN Study

    A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib Administered Once Daily for 52 Weeks in Patients With Non-Cystic Fibrosis Bronchiectasis - The ASPEN Study James D. Chalmers,1 Pierre-Régis Burgel,2 Charles L. Daley,3 Anthon

  2. Slide 2: Forward Looking Statement

    Forward Looking Statement This presentation contains forward-looking statements that involve substantial risks and uncertainties. "Forward-looking statements," as that term is defined in the Private Securities Litigation Reform Act of 1995, are statements that are not historical facts and involve a

  3. Slide 3: Inflammation in Bronchiectasis

    Inflammation in Bronchiectasis • Neutrophilic inflammation is central to the pathophysiology Vicious Vortex of Bronchiectasis1 of non-cystic fibrosis bronchiectasis (hereafter bronchiectasis) and promotes a vicious vortex1 Chronic airway inflammation • Excessive release of neutrophil serine protease

  4. Slide 4: Targeting Neutrophilic Inflammation in Bronchiectasis

    Targeting Neutrophilic Inflammation in Bronchiectasis • NSPs are activated in the bone marrow DPP1 N-terminal dipeptide removed by dipeptidyl peptidase 1 (DPP1)1 • Brensocatib is a novel, oral, selective, competitive, and reversible inhibitor of Inactive DPP1 and is in development for the NSPs treat

  5. Slide 5: ASPEN Study Design

    ASPEN Study Design A phase 3, randomized, double-blind, placebo-controlled 52-week study of 2 doses of brensocatib vs placebo in patients with bronchiectasisa Off 6 weeks Treatment period treatment Primary endpoint: 52 weeks Annualized rate of adjudicated 4 weeks pulmonary exacerbationsb over 52 Bre

  6. Slide 6: Select Key Eligibility Criteria

    Select Key Eligibility Criteria Key inclusion criteriaa Key exclusion criteriaa • Clinical history consistent with bronchiectasis • Underlying diseases – Primary diagnosis of COPD or asthma • CT confirmation of bronchiectasis (secondary diagnoses allowed) • Post-bronchodilator FEV1 ≥30% predicted –

  7. Slide 7: Geographic Distribution of Patients Enrolled

    Geographic Distribution of Patients Enrolled • Patients in the ASPEN trial represent − 5 continents − 35 countries − 391 trial sites − 1680 adultsa − 41 adolescents aAccounts for 2 patients who were not included in the ITT population due to significant GCP non-compliance. GCP, Good Clinical Practice

  8. Slide 8: Patient Disposition

    Patient Disposition Screened (n=2296) Screen failed (n=529, 23.0%)a Not meeting inclusion/exclusion criteria (n=474, 20.6%) Withdrawal of consent (n=49, 2.1%) Other (n=6, 0.3%) Randomized (n=1767) Discontinued due to war in Ukraine (n=44, 2.5%) Significant GCP non-compliance (n=2, 0.1%) Brensocatib

  9. Slide 9: Baseline Characteristics

    Baseline Characteristics Brensocatib 10 mg Brensocatib 25 mg Placebo n=583 n=575 n=563 Age, mean ± SD, years 59.8 ± 15.9 60.6 ± 15.8 60.0 ± 15.4 Age ≥75 years, n (%) 83 (14.2) 84 (14.6) 93 (16.5) Female sex, n (%) 385 (66.0) 360 (62.6) 362 (64.3) White race, n (%) 431 (73.9) 430 (74.8) 405 (71.9) BM

  10. Slide 10: Annualized Rate of Adjudicated Pulmonary Exacerbations Over 52 Weeks

    Annualized Rate of Adjudicated Pulmonary Exacerbations Over 52 Weeks Primary endpoint 1.5 Brensocatib Brensocatib 10 mg 25 mg Annualized rate of exacerbationsa n=583 n=575 21.1% Risk 19.4% Risk 1.286 reduction Rate ratio vs placebo 0.789 0.806 reduction (95% CI) (0.680–0.916) (0.694–0.936) 1 1.015 1

  11. Slide 11: Time to First Exacerbation

    Time to First Exacerbation Secondary endpoint 1.0 Brensocatib Brensocatib 0.9 Placebo Proportion of patients with no 10 mg 25 mg n=563 pulmonary exacerbationa 0.8 n=583 n=575 0.7 Median time, 49.0 50.7 36.7 0.6 weeks (40.0–NE) (37.6–NE) (31.1–41.4) (95% CI) 0.5 0.4 Hazard ratio 0.813 0.825 vs placeb

  12. Slide 12: Proportion of Patients Who Remained Exacerbation-Free

    Proportion of Patients Who Remained Exacerbation-Free Secondary endpoint 100 Brensocatib Brensocatib 10 mg 25 mg 90 n=583 n=575 80 Patients who remained Odds ratio vs placebo 1.412 1.400 exacerbation-free, % 70 (95% CI) (1.105–1.806) (1.095–1.792) 41.2% 40.0% 60 Increased Increased P valuea 0.0059b

  13. Slide 13: Change From Baseline in Post-Bronchodilator FEV1 at Week 52

    Change From Baseline in Post- Bronchodilator FEV1 at Week 52 Secondary endpoint 0 Brensocatib 25 mg showed a LS mean (SE) change from baseline 38 mL less FEV1 decline vs placebo in post-BD FEV1, mLa −20 Brensocatib Brensocatib Placebo 10 mg 25 mg −40 LS mean change from baseline to −50 −24 −62 −60 w

  14. Slide 14: Annualized Rate of Severe Exacerbations

    Annualized Rate of Severe Exacerbations Secondary endpoint Annualized rate of severe exacerbationsa 0.2 Brensocatib Brensocatib 10 mg 25 mg 0.185 n=583 n=575 25.8% Risk 26.0% Risk reduction Rate ratio vs placebo 0.742 0.740 reduction (95% CI) (0.505–1.089) (0.515–1.062) 0.137 0.137 P valueb 0.1277 0

  15. Slide 15: Change From Baseline in QOL-B Respiratory Symptom Domain Score at Week 52

    Change From Baseline in QOL-B Respiratory Symptom Domain Score at Week 52 Secondary endpoint Brensocatib 25 mg showed a nominally significant improvement in 8 QOL-B RSS of 3.8 points vs placebo LS mean (SE) change from baseline in QOL-B RSS 6 Brensocatib Brensocatib Placebo 10 mg 25 mg 4 LS mean cha

  16. Slide 16: Change From Baseline in Post-Bronchodilator FVC at Week 52

    Change From Baseline in Post- Bronchodilator FVC at Week 52 Exploratory endpoint 20 LS mean (SE) change from baseline Brensocatib Brensocatib Placebo 0 10 mg 25 mg in post-BD FVC, mLa −20 LS mean change from baseline to −40 −51 −12 −87 week 52 in post- BD FVC (mL) −60 LS mean −80 difference vs Brens

  17. Slide 17: Change From Baseline in Average Daily BEST Score

    Change From Baseline in Average Daily BEST Score Exploratory endpoint Brensocatib Brensocatib 0.0 Placebo Mean change from baseline in 10 mg 25 mg LS mean change BEST scorea −0.5 from baseline in 52-week average −0.594 −0.999 −0.426 daily BEST −1.0 score LS mean Brensocatib 10 mg difference vs −1.5

  18. Slide 18: Overview of Treatment-Emergent AEs

    Overview of Treatment-Emergent AEsa Brensocatib 10 mg Brensocatib 25 mg Placebo n=582b n=574b n=563b Any AE, n (%) 452 (77.7) 440 (76.7) 448 (79.6) Serious AE 101 (17.4) 97 (16.9) 108 (19.2) Related AE 72 (12.4) 85 (14.8) 73 (13.0) Serious related AE 0 1 (0.2) 0 AE leading to death 3 (0.5) 4 (0.7) 7

  19. Slide 19: AEs of Special Interest

    AEs of Special Interesta Brensocatib 10 mg Brensocatib 25 mg Placebo n=582b n=574b n=563b Any AE of special interest, n (%) 42 (7.2) 56 (9.8) 53 (9.4) Hyperkeratosis 8 (1.4) 17 (3.0) 4 (0.7) Periodontitis/gingivitis 8 (1.4) 12 (2.1) 15 (2.7) Severe infection 4 (0.7) 7 (1.2) 4 (0.7) Pneumonia 23 (4.0

  20. Slide 20: Conclusions

    Conclusions • Brensocatib at both doses, 10 mg and 25 mg once daily, • Significantly reduced the annualized rate of pulmonary exacerbations • Significantly prolonged the time to first exacerbation • Significantly increased the odds of remaining exacerbation-free over the treatment period • Brensocat

  21. Slide 21: Acknowledgements

    Acknowledgements • We thank the patients who participated in the trial and their family members and caregivers, as well as the investigators, clinical research teams, and support staff at the trial sites for providing patient care and their contributions to this study • This study was funded by Insm

  22. Slide 22: Thank You

    hank You » : “4 cy < de = we -_ ul — ~®: 4 Ey er £4 » 5 Pape gatspt™ foees 12624 yea, ss if @ ae

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