Kalvista Pharmaceuticals, Inc. · NASDAQ:KALV
Kalvista Pharmaceuticals — Technical Presentation (May 2025)
11 slides from Kalvista Pharmaceuticals's technical presentation, May 2025
Slide 1: Anxiety Associated with HAE Attacks: Results from the Phase 3 KONFIDENT Trial of Oral Sebetralstat
Anxiety Associated with HAE Attacks: Results from the Phase 3 KONFIDENT Trial of Oral Sebetralstat Timothy Craig,1 Emel Aygören-Pürsün,2 Jonathan A. Bernstein,3 Paula J. Busse,4 Teresa Caballero,5 Danny M. Cohn,6 Mar Guilarte,7 Henriette Farkas,8 Douglas H. Jones,9 Sorena Kiani-Alikhan,10 Michael E.
Slide 2: Disclosures
Disclosures • Timothy Craig has received grants, consulting fees, honoraria, and/or served as an advisory boards and/or data safety monitoring for KalVista Pharmaceuticals, Astria, Takeda, BioMarin Pharmaceuticals, BioCryst, CSL Behring, Grifols, GSK, Intellia Therapeutics, Ionis Pharmaceuticals, Ph
Slide 3: Background
Background Anxiety in people living with HAE is underappreciated • The unpredictable, painful, and life-threatening nature of HAE attacks is associated with substantial psychological burden1-5 • Nearly one-third of respondents from a recent international survey of HAE patients (n=284) experienced mo
Slide 4: KONFIDENT Trial Design and Anxiety Endpoints as Measured by GA-NRS
KONFIDENT Trial Design and Anxiety Endpoints as Measured by Generalized Anxiety Numeric Rating Scale (GA-NRS) • Confirmed diagnosis Rb Attack treated with sebetralstat 300 mg or 600 mg, or placebo of HAE-C1INH • Age ≥12 years • ≥2 attacks within 3 months • Stable LTPa 0.5 h eDiary entry schedule: Ba
Slide 5: Attacks Inducing Moderate to Extreme Anxiety
Attacks Inducing Moderate to Extreme Anxiety • In 261 attacks for which there are GA-NRS All attacks1 Attacks inducing moderate to extreme records in KONFIDENT, the median GA-NRS anxiety N=264 score was 3.0 at baseline n=115/261b (44%) Baseline PGI-S categoryc ‒ 115 attacks (44%) induced moderate to
Slide 6: Reduction in Cumulative GA-NRS Scores
Reduction in Cumulative GA-NRS Scores All attacks Attacks inducing moderate to extreme anxiety GA-NRS Score, Mean (±SE) GA-NRS Score, Mean (±SE) Sebetralstat 300 mg Sebetralstat 300 mg Sebetralstat 600 mg Sebetralstat 600 mg Placebo Placebo Time from First Study Drug Administration, Hours Time from
Slide 7: Changes in LSM Change from Baseline in HAE Attacks in KONFIDENT
Changes in LSM Change from Baseline in HAE Attacks in KONFIDENT • Significantly greater changes from baseline in GA-NRS score were observed at 4 and 12 hours for attacks treated with sebetralstat compared with placebo • LSM change from baseline was more pronounced in attacks that induced moderate to
Slide 8: Time to Reduction in Anxiety in KONFIDENT
Time to Reduction in Anxiety in KONFIDENT • The median time to reduction in anxietya in Percentage of Attacks with ≥2-point Reduction in GA-NRS at ≥2 Consecutive Time Points KONFIDENT for attacks treated with sebetralstat 300 mg or 600 mg was 2.3 hours (IQR: 0.8 to 10.1 and 1.3 to 5.5, respectively)
Slide 9: Agreement of ≥2-point Reduction in Anxiety with Achievement of Beginning of Symptom Relief
Agreement of ≥2-point Reduction in Anxiety with Achievement of Beginning of Symptom Relief Beginning of symptom reliefa within 12 hours Correlation to reduction in anxiety Characteristic within 12 hours,b,c kappa (P value) All attacks 0.47 (<0.0001) Attacks that induced moderate to severe anxiety 0.
Slide 10: Conclusions
Conclusions • In the phase 3 KONFIDENT trial, anxiety was rated as moderate to extreme at the time of treatment in >40% of attacks ‒ In the absence of injectables, anxiety was correlated with baseline attack severity • Compared with placebo, on-demand treatment with sebetralstat reduced anxiety, esp
Slide 11: Acknowledgments
Acknowledgments • We thank the people living with HAE and their families; the HAEA, HAEi and member organizations, and the investigator teams who contributed to the international KONFIDENT trial • Medical writing assistance was provided under the direction of the authors by Richard W. Davis IV, PhD,
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