Kalvista Pharmaceuticals, Inc. · NASDAQ:KALV
Kalvista Pharmaceuticals — Technical Presentation (May 2024)
16 slides from Kalvista Pharmaceuticals's technical presentation, May 31, 2024
Slide 1: Oral Sebetralstat for On-Demand Treatment of HAE: Phase 3 KONFIDENT Results
Oral Sebetralstat for On-Demand Treatment of Hereditary Angioedema: Phase 3 KONFIDENT Trial Results Danny M. Cohn, MD, PhD Amsterdam University Medical Center, University of Amsterdam, Amsterdam, Netherlands 31 May 2024
Slide 2: Disclosures
Disclosures • Danny M. Cohn has received consulting fees paid to the institution, honoraria paid to the institution, meeting/travel support, research support, and/or served on advisory boards from KalVista Pharmaceuticals, Astria, BioCryst, CSL Behring, Intellia, Ionis Pharmaceuticals, Pharming, Pha
Slide 3: Table of Contents
Table of Contents 1 Background 6 Key Secondary Endpoint 2 Study Design 7 Subgroup Analyses 3 Participants 8 Number of Administrations 4 Attack Characteristics 9 Safety 5 Primary Endpoint 10 Key Takeaways
Slide 4: Background
Background Given that attacks are unpredictable and have the potential to rapidly progress, treatment guidelines recommend that patients: Consider treating all attacks, Carry sufficient on-demand Treat attacks as early as irrespective of attack location therapy to treat 2 attacks with possible to ha
Slide 5: Study Design (NCT05259917)
Study Design (NCT05259917) KONFIDENT: International, Randomized, Double-blind, Placebo-controlled Phase 3 Trial a1:1:1:1:1:1 randomization stratified by treatment at enrollment (conventional on-demand therapy only versus stable LTP). LTP, long-term prophylaxis; PGI-C, Patient Global Impression of Ch
Slide 6: Patient Global Impression Scales
Patient Global Impression Scales Patient Global Impression of Change (7-point scale) PGI-C Much Worse Worse A Little Worse No Change A Little Better Better Much Better Patient Global Impression of Severity (5-point scale) PGI-S Very Severe Severe Moderate Mild None
Slide 7: Participants
Participants Participants with at least 1 attack (N=110) Median age, years (IQR) 39.5 (25.0 to 49.0) Female sex, n (%) 66 (60.0) Median BMI, kg/m2 26.2 (22.8 to 31.7) Race, n (%) White 92 (83.6) Asian 10 (9.1) Black or African American 1 (0.9) Other or Not reported 7 (6.3) HAE-C1INH type, n (%) Type
Slide 8: Attack Characteristics
Attack Characteristics Sebetralstat Sebetralstat Placebo All Attacks 300 mg (n=87) 600 mg (n=93) (n=84) (N=264) Baseline pooled attack locations, n (%)a Mucosal (abdomen, larynx/throatb) 36 (41.4) 44 (47.3) 40 (47.6) 120 (45.5) Subcutaneous (all others) 49 (56.3) 49 (52.7) 44 (52.4) 142 (53.8) Basel
Slide 9: Primary Endpoint: Time to Beginning of Symptom Relief
Primary Endpoint: Time to Beginning of Symptom Relief Time to Beginning of Symptom Reliefa 100 75 Proportion of attacks (%) Sebetralstat Sebetralstat Placebo 50 300 mg 600 mg (n=87) (n=93) (n=84) P valueb <0.0001 0.0013 – 25 Median 1.61 h 1.79 h 6.72 h Sebetralstat 300 mg IQR 0.78 to 7.04 1.02 to 3.
Slide 10: Median Time to Beginning of Symptom Relief by Attack and Participant Characteristics
Median Time to Beginning of Symptom Relief by Attack and Participant Characteristics Sebetralstat Sebetralstat Sebetralstat Sebetralstat Median (IQR) 300 mg ● 600 mg ▲ Median (IQR) 300 mg ● 600 mg ▲ 1.61 1.79 1.61 1.79 All attacks All attacks (0.78 to 7.04) (1.02 to 3.79) (0.78 to 7.04) (1.02 to 3.7
Slide 11: Time to Beginning of Symptom Relief: Number of Administrations
Time to Beginning of Symptom Relief: Number of Administrations Sebetralstat Sebetralstat 300 mg (n=86) 600 mg (n=95) Number of attacks treated with, n (%) 1 administration 53 (61.6) 56 (58.9) 2 administrations 33 (38.4) 39 (41.1) Median time between administrations, ha 3.9 3.8 Proportion of attacks
Slide 12: Key Secondary Endpoints
Key Secondary Endpoints Sebetralstat Sebetralstat Placebo 300 mg 600 mg (n=87) (n=93) (n=84) Time to reduction in severity within 12 hoursa,b Adjusted P value compared with placebo 0.004 0.003 – Median (IQR) 9.27 (1.53 to >12) 7.75 (2.19 to >12) >12 (6.23 to >12) Time to complete attack resolution w
Slide 13: Safety
Safety Sebetralstat 300 mg Sebetralstat 600 mg Placebo (n=86) (n=93) (n=83) Number of patients with, n (%) Any TEAE 17 (19.8) 14 (15.1) 17 (20.5) Treatment-related TEAEa 2 (2.3) 3 (3.2) 4 (4.8) Serious TEAEs 1 (1.2)b 2 (2.2) 0 Treatment-related serious TEAE 0 0 0 Severe TEAEs 1 (1.2)b 0 0 Treatment-
Slide 14: Key Takeaways
Key Takeaways • An oral on-demand treatment option is desirable to improve compliance with treatment guidelines and diminish adverse drug reactions • Sebetralstat, an oral plasma kallikrein inhibitor, enabled early treatment of attacks • Compared to placebo, attacks treated with sebetralstat demonst
Slide 15: KONFIDENT Authors Acknowledgements
KONFIDENT Authors Acknowledgements Marc A. Riedl, MD Aharon Kessel, MD Medical writing assistance was provided under the direction of the Henriette Farkas, MD, PhD, DSc Marcin Kurowski, MD authors by Richard W. Davis IV, PhD, CMPP, of ApotheCom and was supported by KalVista Pharmaceuticals. Emel Ayg
Slide 16: EAACI Congress 2024
EAACI Congress 2024 Valencia, Spain 31 May - 3 June Nat Why ALENCIA Revolutionising Patient Care Through the Power of Data Science #EAAClIcongress www.eaaci.org
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