KalVista Pharmaceuticals, Inc. presents three posters at the Western Society of Allergy, Asthma & Immunology 60th Annual Scientific Session in Kona, the United States.

The first highlights that KONFIDENT-S (NCT05505916) is a prospective trial to evaluate the effectiveness and safety of sebetralstat, an investigational oral plasma kallikrein inhibitor, for short-term prophylaxis. The second reports phase 1 data evaluated the pharmacokinetic and pharmacodynamic parameters of sebetralstat in Japanese adults. These positive Phase 1 data support the expansion of the KONFIDENT (NCT05259917) phase 3 trial to Japan. Finally, KalVista presents a post hoc analysis of phase 2 trial data demonstrating that sebetralstat provided similar symptom relief, reduction in attack severity, and use of rescue regardless of abdominal or peripheral attack location.

Targeted Literature Review to Assess the Studies Supporting Short-term Prophylactic Treatment Options for the Preprocedural Prevention of Attacks in Patients With HAE – Dr. Marc A. Riedl, Division of Rheumatology, Allergy and Immunology, University of California San Diego, United States:
The literature review confirms that there are few prospective and no controlled studies in the short-term prophylaxis setting that support the present first-line treatment options for preprocedural prevention of acute HAE attacks. Consistent with prior studies, therefore, we have designed a 2-year, open-label, phase 3 extension trial (KONFIDENT-S, NCT05505916), which will evaluate the safety of sebetralstat, an investigational oral plasma kallikrein inhibitor for the on-demand treatment of HAE attacks, while also prospectively evaluating the effectiveness and safety of sebetralstat in the preprocedural short-term prophylaxis setting. KONFIDENT-S is the first prospective trial that will evaluate an oral on-demand therapy for short-term prophylaxis.

Pharmacokinetic, Pharmacodynamic, and Safety Profile of Sebetralstat in Healthy Japanese and White Adults: Results From a Phase 1, Randomized, Double-Blind, Placebo-Controlled Trial – Matthew Iverson, KalVista Pharmaceuticals Inc., Cambridge, MA, United States:
Sebetralstat has comparable pharmacokinetic, pharmacodynamic, and safety profiles in healthy Japanese and White adults. These findings support the inclusion of Japanese patients with HAE in the KONFIDENT phase 3 trial (NCT05259917) to assess sebetralstat as on-demand treatment for HAE attacks.

Efficacy of the Oral Plasma Kallikrein Inhibitor Sebetralstat (KVD900) by Attack Location in a Phase 2 Clinical Trial in Patients With HAE – Dr. Paul K. Audhya, KalVista Pharmaceuticals Inc., Cambridge, MA, United States:
Sebetralstat treatment resulted in rapid symptom relief for both abdominal and peripheral attacks, with approximately 80% achieving symptom relief within 12 hours regardless of attack location as evaluated by a score of “A Little Better” or higher for 2 consecutive timepoints on the PGI-C scale. Abdominal attacks tended to resolve more quickly than peripheral attacks as evaluated on PGI-S and VAS scales. Faster symptom relief for abdominal versus peripheral attacks observed in this study is consistent with previously reported findings for other acute therapies. The use of rescue medication for abdominal and peripheral attacks treated by sebetralstat was also similar, although somewhat more abdominal attacks were rescued earlier, while more peripheral attacks were rescued later. The results of this post hoc analysis demonstrate that sebetralstat provides symptom relief and attack resolution for people living with HAE, regardless of abdominal or peripheral attack location.
(Source: KalVista)