Update on progress of sebetralstat development in hereditary angioedema
KalVista Pharmaceuticals, Inc. a clinical stage pharmaceutical company focused on the discovery, development, and commercialization of oral, small molecule protease inhibitors, provided multiple clinical trial and regulatory updates for its lead compound sebetralstat, as a potential oral on-demand therapy for HAE attacks
Clinical Trial and Regulatory Updates: i. KalVista has enrolled more than 50% of the 114 targeted number of patients in the pivotal phase III KONFIDENT clinical trial. The trial will conclude once 84 of the patients enrolled complete the three-attack treatment sequence. As per previous guidance, topline data for the trial remains expected in the second half of 2023. ii. KONFIDENT is currently enrolling patients at more than 50 active sites in 17 countries, and the KONFIDENT-S open label extension study also continues to enroll in accordance with plan. iii. The Company recently received additional FDA regulatory guidance for the oral disintegrating tablet (ODT) formulation of sebetralstat that confirmed the requirements to support a supplemental NDA (sNDA) filing. The guidance from FDA included that no efficacy trials with the ODT formulation will be required prior to filing the supplemental NDA (sNDA) filing. KalVista anticipates that the ODT formulation will follow the expected initial launch formulation in the US and EU, although it may become the initial launch formulation in other geographies.
KalVista also recently received guidance from the Japanese regulatory authority (PMDA) on the clinical development pathway to a regulatory submission in that country. KalVista will now be enrolling Japanese patients in both KONFIDENT and KONFIDENT-S to support the filing, and clinical sites for Japanese enrollment have been selected and start up activities are underway.
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