Slide 1: ASPEN Topline Results
ASPEN Topline Results May 28, 2024
Slide 2: Forward Looking Statements
Forward Looking Statement Forward Looking Statements 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 hist
Slide 3: Opening Remarks
Opening Remarks Will Lewis Chair & Chief Executive Officer
Slide 4: ASPEN Is a Clear Win for Patients
Both Doses of Brensocatib Achieved… ASPEN Is a Clear Win for Patients Statistically significant <0.01 p-value on primary endpoint Clinically meaningful reduction in exacerbations Statistical significance on multiple secondary endpoints Favorable safety and tolerability profile Sets Clear Path to App
Slide 5: ASPEN Results
ASPEN Results Martina Flammer, M.D. Chief Medical Officer
Slide 6: ASPEN Phase 3 Study Design of Brensocatib
ASPEN is a Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study of Brensocatib Primary endpoint:Rate of adjudicated pulmonary exacerbations (PEs) over 52 weeks Secondary endpoints: Time-to-first PE Percentage PE free Change in FEV1 Rate of severe PEs Change in QoL-B respiratory score
Slide 7: Baseline Characteristics Were Well-Balanced Across Treatment Arms
Baseline Characteristics Were Well-Balanced Across Treatment Arms Brensocatib 10 mgn=583 Brensocatib 25 mgn=575 Placebon=563 Age (years), mean ± SD 59.8 ± 15.9 60.6 ± 15.8 60.0 ± 15.4 Age ≥65 years, n (%) 277 (47.5) 302 (52.5) 260 (46.2) Age ≥75 years, n (%) 83 (14.2) 84 (14.6) 93 (16.5) Female sex,
Slide 8: Primary Endpoint Achieved Statistical Significance on Both Doses
Clear Win: Primary Endpoint Achieved Statistical Significance on Both Doses Brensocatib 10 mg compared to placebo Brensocatib 25 mg compared to placebo Primary Endpoint Reduction in annualized rate of PEs 21.1% p = 0.0019* 19.4% p = 0.0046* Secondary Endpoints Prolongation of time to first PE 18.7%
Slide 9: TEAEs and Treatment Discontinuations Comparable to Placebo
TEAEs and Treatment Discontinuations Were Comparable in Brensocatib and Placebo Arms Brensocatib 10 mgn=582 Brensocatib 25 mgn=574 Placebon=563 Any TEAE, n (%) 452 (77.7) 440 (76.7) 448 (79.6) Severe TEAE, n (%) 74 (12.7) 67 (11.7) 90 (16.0) Serious TEAE, n (%) 101 (17.4) 97 (16.9) 108 (19.2) TEAE l
Slide 10: Key Opinion Leader Insights
Key Opinion Leader Insights James Chalmers, MBChB, Ph.D. Professor and Consultant Respiratory Physician at the School of Medicine, University of Dundee, UK Lead Investigator, ASPEN
Slide 11: ASPEN confirms DPP1 inhibition effects in bronchiectasis
ASPEN confirms DPP1 inhibition can have profound effects in bronchiectasis Reduction in rate of PEs for both doses in ASPEN is clinically relevant and important Impact on lung function decline and symptoms for 25mg dose is very exciting Brensocatib Has Potential to Transform the Management of Bronch
Slide 12: Closing Remarks
Closing Remarks Will Lewis Chair & Chief Executive Officer
Slide 13: The ASPEN Study is an Historic Win for Patients
Nominally significant improvement in QOL-B scores (25 mg dose only) The ASPEN Study is an Historic Win for Patients with Bronchiectasis Significantly less lung function decline (25 mg dose only) Safety and tolerability profile similar to placebo Significantly reduced annual rate of exacerbations Sig
Slide 14: Join Us for a Commercial Webinar
Join Us Tuesday, June 4, 2024, for a Commercial Webinar Insmed’s commercial leadership will provide details on the market outlook for ARIKAYCE® (amikacin liposome inhalation suspension), brensocatib, and TPIP
Slide 15: Thank You
hank You de