Kiniksa Pharmaceuticals International, Plc · NASDAQ:KNSA
Kiniksa Pharmaceuticals International — Conference Presentation (June 2020)
22 slides from Kiniksa Pharmaceuticals International's conference presentation, Jun 29, 2020
Slide 1: RHAPSODY Top-Line Results
Exhibit 99.2Every Second Counts!™RHAPSODY Top-Line Results June 2020
Slide 2: Welcome
WelcomeMark Ragosa VP of Investor Relations and FinanceEvery Second Counts!TM2
Slide 3: Forward Looking Statements
Forward Looking StatementsThis presentation (together with any other statements or information that we may make in connection herewith) contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 with respect to Kiniksa Pharmaceuticals, Ltd. (and it
Slide 4: Introduction
IntroductionSanj K. Patel CEO and Chairman of the BoardEvery Second Counts!TM4
Slide 5: Summary of Pivotal Phase Trial of Rilonacept in Recurrent Pericarditis
Summary of Pivotal Phase 3 Trial of Rilonacept in Recurrent Pericarditis• Prespecified primary and all major secondary efficacy endpoints were highly statistically significant.• The primary efficacy endpoint of median time-to-first adjudicated pericarditis recurrence in the randomized withdrawal per
Slide 6: RHAPSODY Top-Line Results
RHAPSODY Top-Line ResultsJohn F. Paolini Chief Medical OfficerEvery Second Counts!TM6
Slide 7: Rilonacept
RilonaceptIndication1 Recurrent Pericarditis: Painful and debilitating autoinflammatory cardiovascular diseaseMechanism of Action2IL-1α and IL-1β cytokine trapScientific Rationale2 IL-1α and IL-1β are cytokines shown to play key role in inflammatory diseasesPrevalence3~40k prevalent in U.S.; address
Slide 8: Design of Pivotal Phase Trial of Rilonacept in Recurrent Pericarditis
Design of Pivotal Phase 3 Trial of Rilonacept in Recurrent PericarditisLoading Dose 320 mg SCRandomization 1:1Primary Efficacy Endpoint Time-to-First-Adjudicated Pericarditis-RecurrenceEnd of Study (EOS)Screening PeriodSingle-Blind Run-In Period (12-week)Double-Blind, Placebo-Controlled, Randomized-
Slide 9: Baseline Demographics and Clinical Characteristics
Baseline Demographics and Clinical Characteristics Pivotal Phase 3 Rilonacept DataBaseline Demographics (n=86)Prior Pericarditis History at Baseline (n=86)Qualifying Episode CRP & NRS (n=86)SexMaleFemale43%57%IdiopathicPost-Pericardiotomy85%106.18106.20 RaceWhite Black or African American5.8%% of Pa
Slide 10: Subject Disposition
Subject Disposition Pivotal Phase 3 Rilonacept DataMedian time to Monotherapy rilonacept = 7.9 weeks (7.0, 8.1) Median time to Pain Response2 5.0 days (4.0, 6.0) Median time to CRP Normalization3 = 7.0 days (5.0, 8.0) Median time to Treatment Response4 = 5.0 days (4.0, 7.0)RUN-IN COMPLETED n = 79 (9
Slide 11: Primary Efficacy Endpoint: Time-to-First Adjudicated Pericarditis Recurrence
Primary Efficacy Endpoint: Time-to-First Adjudicated Pericarditis Recurrence Pivotal Phase 3 Rilonacept DataHR = 0.04 p-value < 0.0001 Relative Risk Reduction = 96%Pericarditis Recurrence Categories, n (%) KPL-914 (N=30)Placebo (N=31)Number of Subjects with Events (Adjudicated Pericarditis Recurrenc
Slide 12: Secondary Endpoints at Week of the Randomized Withdrawal Period
Secondary Endpoints at Week 16 of the Randomized Withdrawal Period Pivotal Phase 3 Rilonacept DataProportion of Subjects Who Maintained Clinical Response 1Proportion of Subjects with Absent/Minimal Pericarditis Symptoms based on the 7-point PGIPS 2Percent of Days with No or Minimal Pain in First 16
Slide 13: Summary of Adverse Events
Summary of Adverse Events Pivotal Phase 3 Rilonacept DataRun-In Period Randomized Withdrawal PeriodRun-In Period Randomized Withdrawal PeriodCategory 1KPL-914 (N=86) n (%)KPL-914 Including Bailout Rilonacept (N=30) n (%)Placebo Only Before Bailout Rilonacept (N=31) n (%)Category 1KPL-914 (N=86) n (%
Slide 14: Recurrent Pericarditis U.S. Prevalence Estimated to be ~40K Patients
Recurrent Pericarditis U.S. Prevalence Estimated to be ~40K Patients Addressable U.S. opportunity for rilonacept estimated to be ~14K patientsRefractoryMultiple RelapsingSteroid- DependentPatient fails to respond, or is intolerant, to NSAIDs, colchicine, and steroids (~3K)or patient fails to respond
Slide 15: Product Candidates and Clinical Status
Product Candidates and Clinical StatusIndicationRecurrent PericarditisGiant Cell ArteritisProgram & TargetRilonacept1 IL-1α & IL-1βMavrilimumab GM-CSFRαPreclinicalPhase 1 Phase 2 Phase 3StatusPivotal Phase 3 Data Announced in June 2020Phase 2 Data Expected in Q4 2020COVID-19 Pneumonia & Hyperinflamm
Slide 16: Every Second Counts!
Every Second Counts!™
Slide 17: Appendix
AppendixEvery Second Counts!TM17
Slide 18: Summary of Adverse Events
Summary of Adverse Events Pivotal Phase 3 Rilonacept DataRun-In Period Randomized Withdrawal PeriodRun-In Period Randomized Withdrawal PeriodCategory 1KPL-914 (N=86) n (%)KPL-914 Including Bailout Rilonacept (N=30) n (%)Placebo Only Before Bailout Rilonacept (N=31) n (%)Category 1KPL-914 (N=86) n (%
Slide 19: Summary of Adverse Events
Summary of Adverse Events Pivotal Phase 3 Rilonacept DataRun-In Period Randomized Withdrawal PeriodRun-In Period Randomized Withdrawal PeriodCategory 1KPL-914 (N=86) n (%)KPL-914 Including Bailout Rilonacept (N=30) n (%)Placebo Only Before Bailout Rilonacept (N=31) n (%)Category 1KPL-914 (N=86) n (%
Slide 20: Summary of Adverse Events
Summary of Adverse Events Pivotal Phase 3 Rilonacept DataRun-In Period Randomized Withdrawal PeriodRun-In Period Randomized Withdrawal PeriodCategory 1KPL-914 (N=86) n (%)KPL-914 Including Bailout Rilonacept (N=30) n (%)Placebo Only Before Bailout Rilonacept (N=31) n (%)Category 1KPL-914 (N=86) n (%
Slide 21: Summary of Adverse Events
Summary of Adverse Events Pivotal Phase 3 Rilonacept DataRun-In Period Randomized Withdrawal PeriodRun-In Period Randomized Withdrawal PeriodCategory 1KPL-914 (N=86) n (%)KPL-914 Including Bailout Rilonacept (N=30) n (%)Placebo Only Before Bailout Rilonacept (N=31) n (%)Category 1KPL-914 (N=86) n (%
Slide 22: Summary of Adverse Events
Summary of Adverse Events Pivotal Phase 3 Rilonacept DataRun-In Period Randomized Withdrawal PeriodRun-In Period Randomized Withdrawal PeriodCategory 1KPL-914 (N=86) n (%)KPL-914 Including Bailout Rilonacept (N=30) n (%)Placebo Only Before Bailout Rilonacept (N=31) n (%)Category 1KPL-914 (N=86) n (%
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