KalVista Pharmaceuticals Shares Sebetralstat Data at 2024 Bradykinin Symposium
KalVista Pharmaceuticals, Inc. recently showcased new analyses of the efficacy and safety of its investigational drug, sebetralstat, at the Bradykinin Symposium 2024 in Berlin, Germany. Sebetralstat is an oral plasma kallikrein inhibitor designed for the on-demand treatment of hereditary angioedema (HAE) attacks in individuals aged 12 and older. This drug aims to provide a more convenient alternative to current injectable treatments, which often lead to injection-site reactions or pain.
Dr. Emel Aygören-Pürsün, a leading investigator in the trials, highlighted that sebetralstat could potentially eliminate the challenges associated with injectable treatments for HAE. According to her, the clinical trials demonstrated that sebetralstat offers rapid symptom relief and has a safety profile comparable to a placebo. Dr. Aygören-Pürsün posited that if sebetralstat is approved, it could significantly improve the standard of care for HAE by addressing critical gaps in current treatment options.
Dr. Paul Audhya, Chief Medical Officer of KalVista Pharmaceuticals, emphasized the consistent safety and efficacy observed across the clinical program for sebetralstat. He expressed optimism that sebetralstat could revolutionize HAE management.
Several key presentations at the symposium provided deeper insights into sebetralstat's potential.
1. Delayed Treatment and Associated Barriers in Italy:
Dr. Mauro Cancian from the University of Padova reported that many Italian patients did not adhere to guideline recommendations for early on-demand treatment following HAE attack recognition. This delay often led to more severe attacks.
2. Efficacy Analysis:
A pooled analysis conducted by Dr. Emel Aygören-Pürsün demonstrated the efficacy of sebetralstat in providing rapid symptom relief, offering an oral administration route that could enable earlier treatment of HAE attacks.
3. Safety Analysis:
Another pooled analysis by Dr. Aygören-Pürsün showed that sebetralstat was well-tolerated, with a safety profile similar to that of a placebo in phase 2 and phase 3 double-blind, placebo-controlled crossover trials.
4. Interim Analysis of KONFIDENT-S:
Dr. Henriette Farkas from Semmelweis University in Budapest presented interim data from the KONFIDENT-S trial. Among 640 attacks treated, the median time to treatment was 9 minutes, with symptom relief beginning within 1.8 hours on average. For laryngeal attacks, the median time to treatment was 8 minutes and symptom relief started within 1.3 hours.
5. European Subgroup in KONFIDENT Phase 3 Trial:
Dr. Andrea Zanichelli from the University of Milan shared that the efficacy and safety of sebetralstat were consistent both in European participants and the overall cohort in the KONFIDENT phase 3 trial.
6. Plasma Kallikrein Activity as a Biomarker:
Daniel Lee from KalVista Pharmaceuticals discussed the potential of measuring specific plasma kallikrein activity as a biomarker for normal C1INH, which currently lacks a standardized diagnostic pathway.
Sebetralstat was discovered and developed by KalVista's scientific team and has received Fast Track and Orphan Drug Designations from the U.S. FDA, along with equivalent designations from the European Medicines Agency (EMA). KalVista aims to make sebetralstat an advanced treatment option for HAE, providing a more convenient and effective alternative to current therapies, with ongoing plans to seek regulatory approvals worldwide.
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