Kiniksa Pharmaceuticals International, Plc · NASDAQ:KNSA
Kiniksa Pharmaceuticals International — Technical Presentation (April 2020)
16 slides from Kiniksa Pharmaceuticals International's technical presentation, Apr 22, 2020
Slide 1: Vixarelimab (KPL-716) Phase 2a Prurigo Nodularis Data
Vixarelimab (KPL - 716) Phase 2a Prurigo Nodularis Data April 2020 Every Second Counts!™
Slide 2: Summary of Vixarelimab Phase 2a Study in Prurigo Nodularis
Summary of Vixarelimab Phase 2a Study Prurigo Nodularis 2 Enrolled and treated 49 patients with moderate - to - severe prurigo nodularis (mean PN - IGA of 3.4) experiencing moderate - to - severe pruritus (mean WI - NRS score of 8.3) • Randomized 1:1 to receive a loading dose of vixarelimab 720 mg (
Slide 3: Vixarelimab Phase 2a Trial in Prurigo Nodularis
Vixarelimab Phase 2a Trial in Prurigo Nodularis Phase 2a Proof - of - Concept Objective : Assess pruritus reduction Dose: 720 mg SC loading dose -- > 360 mg single SC QW thereafter Primary Efficacy Endpoint : % change from baseline in weekly average Worst Itch - Numeric Rating Scale (WI - NRS) Vixar
Slide 4: Baseline Characteristics
Baseline Characteristics General Characteristics* Vixarelimab (n=23) Placebo (n=26) Total (n=49) Age (Mean Years) 52 64 58 Sex (Male/Female) 10/13 10/16 20/29 Race White (n) 65.2% (15) 80.8% (21) 73.5% (36) Black or African American (n) 21.7% (5) 11.5% (3) 16.3% (8) Asian (n) 8.7% (2) 0 4.1% (2) Ame
Slide 5: Clinical Findings at Baseline: History of Atopy
5 Clinical Findings at Baseline: History of Atopy 65.2 4.3 4.3 69.2 3.8 7.7 Presence of Atopy, % Historical Asthma, % Historical Atopic Dermatitis, % % of Subjects 5 8.7 8 Weekly Average WI - NRS ( mean) PN - IGA (mean) WI - NRS Score Vixarelimab Placebo Baseline Characteristics Clinical Findings at
Slide 6: Phase 2a Study Showed Statistically Significant Reduction in Mean Weekly-Average WI-NRS Versus Placebo
Vixarelimab (KPL - 716) Phase 2 Study Showed a Statistically Significant Reduction in Mean Weekly - Average WI - NRS Versus Placebo Median change from baseline in weekly - average WI - NRS at Week 8 was - 69.8% 6 0 1 2 3 4 5 6 7 8 -70% -60% -50% -40% -30% -20% -10% 0% Weeks % C h a n g e f r o m B a
Slide 7: The Majority of Recipients Showed a Clinically Meaningful ≥4-Point WI-NRS Reduction
The Majority of Vixarelimab (KPL - 716) Recipients Showed a Clinically Meaningful ≥4 - Point WI - NRS Reduction 7 WI - NRS = Worst - Itch Numeric Rating Scale 52.2% 30.8%
Slide 8: The Majority of Recipients Showed a Clinically Meaningful ≥4-Point WI-NRS Reduction
The Majority of Vixarelimab (KPL - 716) Recipients Showed a Clinically Meaningful ≥4 - Point WI - NRS Reduction BL Wk 1 Wk 2 Wk 3 Wk 4 Wk 5 Wk 6 Wk 7 Wk 8 -100% -80% -60% -40% -20% 0% 20% Trial Week % C h a n g e i n W e e k l y A v e r a g e W I - N R S KPL-716 Per Subject Plots 4 Point Responder =
Slide 9: Disease Severity Response: Significantly More Recipients Attained Clear/Almost Clear Lesion Score
Disease Severity Response: Significantly More Vixarelimab (KPL - 716) Recipients Attained A Clear/Almost Clear Lesion Score by Week 8 Versus Placebo BL Wk 2 Wk 4 Wk 6 Wk 8 0 10 20 30 40 50 60 70 80 90 Trial Week % o f S u b j e c t s PN-IGA Score of 0 or 1 & a ³2 Point Reduction KPL-716 Placebo * *
Slide 10: Concordant Effect on PN-IGA and Pruritus
Concordant Effect of Vixarelimab (KPL - 716) on PN - IGA and Pruritus KPL-716 Placebo 0% 20% 40% 60% 80% 100% % o f S u b j e c t s % of IGA 0-1 Subjects with ³4 Point Change in WI-NRS KPL-716 Placebo 0% 20% 40% 60% 80% 100% % o f S u b j e c t s % of Subjects with ³4 Point Change in WI-NRS and an I
Slide 11: Representative Images of Nodule Resolution at Week 8 in Two Vixarelimab-Treated Subjects
Representative Images of Nodule Resolution at Week 8 in Two Vixarelimab - Treated Subjects 11 Subject 1 Subject 2 Day 1 Week 8 WI - NRS = 8.43 PN - IGA = 4 WI - NRS = 1.67 PN - IGA = 1 WI - NRS = 9.29 PN - IGA = 4 WI - NRS = 0 PN - IGA = 2
Slide 12: Vixarelimab Was Well-Tolerated in Prurigo Nodularis Phase 2a Study
Vixarelimab was Well - Tolerated in Prurigo Nodularis Phase 2a Study 12 Vixarelimab (n=23) Placebo (n=26) Any AE (n) 82.6% (19) 65.4% (17) TEAE (n) 82.6% (19) 65.4% (17) Drug - Related TEAE (n) 39.1% (9) 30.8% (8) Serious TEAE 0 0 Drug - Related Serious TEAE 0 0 TEAE Leading to Treatment Discontinua
Slide 13: Vixarelimab Was Well-Tolerated in Prurigo Nodularis Phase 2a Study
Vixarelimab was Well - Tolerated in Prurigo Nodularis Phase 2a Study 13 System Organ Class Preferred Term Vixarelimab (n=23) Placebo (n=26) Infections and Infestations (n) 30.4% (7) 46.2% (12) Upper Respiratory Tract Infection (n) 17.4% (4) 3.8% (1) Nasopharyngitis (n) 4.3% (1) 7.7% (2) Gastroenteri
Slide 14: Vixarelimab Was Well-Tolerated in Prurigo Nodularis Phase 2a Study
Vixarelimab was Well - Tolerated in Prurigo Nodularis Phase 2a Study 14 System Organ Class Preferred Term Vixarelimab (n=23) Placebo (n=26) Skin and Subcutaneous Tissue Disorders 26.1% (6) 15.4% (4) Eczema Nummular 4.3% (1) 3.8% (1) Pruritus 4.3% (1) 3.8% (1) Dermatitis Allergic 4.3% (1) 0 Idiopathi
Slide 15: Summary of Vixarelimab Phase 2a Study in Prurigo Nodularis
Summary of Vixarelimab Phase 2a Study Prurigo Nodularis 15 Enrolled and treated 49 patients with moderate - to - severe prurigo nodularis (mean PN - IGA of 3.4) experiencing moderate - to - severe pruritus (mean WI - NRS score of 8.3) • Randomized 1:1 to receive a loading dose of vixarelimab 720 mg
Slide 16: Every Second Counts!™
Every Second Counts!™
Kiniksa Pharmaceuticals — Technical Presentation (April 2020) on 6ix