Kalvista Pharmaceuticals, Inc. · NASDAQ:KALV
Kalvista Pharmaceuticals — Technical Presentation (2024)
11 slides from Kalvista Pharmaceuticals's technical presentation, 2024
Slide 1: Pooled Sebetralstat Placebo-controlled Safety for On-demand Treatment of Hereditary Angioedema
Pooled Sebetralstat Placebo-controlled Safety for On-demand Treatment of Hereditary Angioedema Emel Aygören-Pürsün,1 Jonathan A. Bernstein,2 Danny Cohn,3 Henriette Farkas,4 William Lumry,5 Marc Riedl,6 Andrea Zanichelli,7,8 Samuel Owiredu-Yeboa,9 James Hao,9 Michael D. Smith,9 Christopher M. Yea,9 P
Slide 2: Disclosures
Disclosures • EA-P: has received grants, consulting fees, honoraria, fees paid to the institution, and/or personal fees from KalVista Pharmaceuticals, Astria, BioCryst, BioMarin Europe, Centogene, CSL Behring, Intellia, Pharming Technologies, Pharvaris, and Takeda/Shire. • JAB: has received grants a
Slide 3: Background
Background consider treating all Early treatment attacks1 is associated with less severe and The shorter attacks1,2 unpredictability and potential treat attacks as lethality of HAE early as possible1 Parenterally administered attacks calls for on-demand therapies for patients to: treatment of HAE at
Slide 4: Adverse Drug Reactions of On-demand Therapies
Adverse Drug Reactions of On-demand Therapies • Approved subcutaneously administered on-demand HAE therapies may be associated with injection site adverse drug reactions such as pain, swelling, erythema, itching, and burning sensation1–2 • Other commonly reported adverse reactions including headache
Slide 5: Objective
Objective To evaluate the safety (ie, adverse events) of sebetralstat, an investigational oral plasma kallikrein inhibitor for on-demand treatment of HAE attacks, in the phase 2 and 3 trials1–4 References: 1. ClinicalTrials.gov. A phase II, cross-over clinical trial evaluating the efficacy and safet
Slide 6: Trial Designs
Trial Designs Eligibility: Phase 2ab Phase 3a • Confirmed diagnosis of Attack 1 treatment Attack 2 treatment Attack 1 treatment Attack 2 treatment Attack 3 treatment HAE-C1INH Sebetralstat 600 mg Placebo Sebetralstat 300 mg Sebetralstat 600 mg Placebo • Aged ≥18 years (phase 2); 1 dose 1 dose 1-2 do
Slide 7: Characteristics of Participants Treated with Sebetralstat or Placebo
Pooled Characteristics of Participants Treated with Sebetralstat or Placebo Sebetralstat 300 mg Sebetralstat 600 mg Placebo (n=86) (n=151) (n=138) Age, mean (SD) years 37.0 (14.6) 38.0 (14.1) 38.3 (14.4) Age group, n (%) Adolescent (≥12 to <18 years) 10 (11.6) 11 (7.3) 9 (6.5) Adult (≥18 to <65 year
Slide 8: Pooled Safety
Pooled Safety Sebetralstat 300 mg Sebetralstat 600 mg Placebo Number of participants, n (%) (n=86) (n=151) (n=138) Any TEAE 17 (19.8) 28 (18.5) 24 (17.4) Treatment-related TEAEa 2 (2.3) 6 (4.0) 6 (4.3) Any serious TEAE 1 (1.2)d 2 (1.3) 0 Treatment-related serious TEAEb 0 0 0 Any severe TEAE 1 (1.2)d
Slide 9: Pooled Safety
Pooled Safety Sebetralstat 300 mg Sebetralstat 600 mg Placebo Preferred Term, n (%) Ea (n=86) (n=151) (n=138) Treatment-related TEAE 2 (2.3) 2 6 (4.0) 7 6 (4.3) 7 Dyspepsia 1 (1.2) 1 1 (0.7) 1 0 Upper abdominal pain 0 1 (0.7) 1 0 Nausea 0 1 (0.7) 1 1 (0.7) 1 Anal incontinence 0 0 1 (0.7) 1 Fatigue 1
Slide 10: Conclusions
Conclusions • Adverse drug reactions associated with subcutaneous and intravenous administration may cause patients to delay or withhold treatment1–7 • Other commonly reported adverse reactions of parenteral therapies for HAE include headache, nausea, and dizziness1–7 • In this pooled safety analysi
Slide 11: Acknowledgements
Acknowledgements KalVista thanks the people living with HAE and their families, their advocates, and the investigator teams around the world who supported these clinical trials. Medical writing assistance was provided under the direction of the authors by Marisa DeGuzman, PhD, of Oxford PharmaGenesi
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