KalVista Pharmaceuticals Presents Sebetralstat Data at Bradykinin Symposium 2024

KalVista Pharmaceuticals announced that it presented additional analyses of the efficacy and safety of sebetralstat from phase 2 and phase 3 double-blind, placebo-controlled crossover clinical trials as well as interim data from KONFIDENT-S, a phase 3 open-label extension trial, and real-world patient data at the Bradykinin Symposium 2024 taking place in Berlin, Germany, on 5-6 September 2024.

Emel Aygören-Pürsün MD, Specialist in Internal Medicine at the Division of Oncology, Hematology and Hemostaseology at the Department for Children and Adolescents of the University Hospital Frankfurt, is a leading investigator for the phase 2, phase 3 KONFIDENT and KONFIDENT-S trials. She said: “Delay or denial in the treatment of HAE attacks is often related to the administration of the currently approved injectable on-demand treatments. The data presented today highlight that oral sebetralstat may remove these challenges and has a safety profile no different than placebo.”

“Sebetralstat also resulted in rapid symptom relief in the clinical trials. If approved, sebetralstat might become a major advance for people living with HAE by addressing critical gaps in the current standard of care for on-demand treatment of attacks.”

Paul Audhya MD MBA, Chief Medical Officer of KalVista Pharmaceuticals, said: “We are encouraged by the observation of exceptional consistency of both safety and efficacy across the entire clinical program for sebetralstat for the on-demand treatment of HAE. These data reinforce the potential for sebetralstat to transform the management of HAE.”

The presentations at Bradykinin Symposium 2024 included:

  • Delayed On-demand Treatment of Hereditary Angioedema Attacks and Associated Barriers Reported by Italian patients: Mauro Cancian, Azienda Ospedaliera, Università degli Studi di Padova, Padova, Italy (Oral presentation)

Many patients did not meet guideline recommendations for early on-demand treatment following attack recognition, which resulted in more severe attacks.

  • Pooled Sebetralstat Placebo-controlled Efficacy for On-demand Treatment of Hereditary Angioedema: Emel Aygören-Pürsün, University Hospital Frankfurt, Goethe University Frankfurt, Germany (Poster presentation)

Pooled analysis of a larger number of HAE attacks corroborates the efficacy of sebetralstat for on-demand treatment, offering an oral administration route to potentially enable early treatment and rapid symptom relief.

  • Pooled Sebetralstat Placebo-controlled Safety for On-demand Treatment of Hereditary Angioedema: Emel Aygören-Pürsün, University Hospital Frankfurt, Goethe University Frankfurt, Germany (Oral presentation)

In the pooled safety analysis in phase 2 and phase 3 double-blind, placebo-controlled crossover trials, sebetralstat was well-tolerated with a safety profile no different than placebo.

  • KONFIDENT-S Interim Analysis: Sebetralstat for Hereditary Angioedema Attacks Including Laryngeal: Henriette Farkas, Hungarian Angioedema Center of Reference and Excellence, Semmelweis University, Budapest, Hungary (Oral presentation)

Among 640 attacks treated, median time to treatment was 9 minutes for all attacks and 8 minutes for laryngeal attacks; the median time to beginning of symptom relief was 1.8 hours for all attacks and 1.3 hours for laryngeal attacks.

  • Phase 3 KONFIDENT Trial of Sebetralstat for HAE: European Subgroup: Andrea Zanichelli, Operative Unit of Medicine, Angioedema Center, IRCCS Policlinico San Donato, San Donato Milanese, Milan, Italy; Department of Biomedical Sciences for Health, University of Milan, Milan, Italy (Poster presentation)

In the KONFIDENT phase 3 clinical trial, the positive efficacy and safety of sebetralstat as an on-demand treatment for HAE was consistent between European participants and the overall cohort.

  • A specific, sensitivity assay measuring patient sample plasma kallikrein activity: Daniel Lee, KalVista Pharmaceuticals (Oral presentation)

Measuring specific plasma kallikrein activity could be useful as a biomarker for normal C1INH, which currently has no standardized diagnostic pathway.

(Source: KalVista)