KalVista Pharmaceuticals provided clinical trial and regulatory updates for its lead program sebetralstat, in development as a potential oral on-demand therapy for hereditary angioedema (HAE).
Clinical Trial and Regulatory Updates:
KalVista has achieved the targeted number of on-treatment attacks required to complete the phase 3 KONFIDENT trial. The trial is a cross-over study in which patients are intended to treat a total of three attacks: one each with 300 mg sebetralstat, 600 mg sebetralstat and placebo, given in a randomized sequence.
Topline data readout is expected in early 2024, remaining on track for a New Drug Application (NDA) submission to the US Food and Drug Administration (FDA) in the first half of 2024. The Company also expects to file for approval in the European Union and Japan later in 2024.
KONFIDENT randomized a total of 136 participants from 66 sites across 20 countries, making it the largest clinical trial ever conducted in HAE based on number of subjects. The enrolled patients are representative of the global HAE population and include participants 12 years of age and above, with or without long-term prophylaxis, with all attack locations eligible for treatment, including the larynx.
In addition, the KONFIDENT-S open label extension study continues to enroll, and the Company expects it will provide a robust safety database to support the planned NDA filing. In total, more than 600 attacks have been treated across KONFIDENT and KONFIDENT-S, and KONFIDENT-S includes numerous patients who have taken multiple doses for treatment as well as short-term prophylaxis.
Andrew Crockett, Chief Executive Officer of KalVista, said: “We are excited to have reached the number of on-treatment attacks required for completion of KONFIDENT. We have now initiated study closeout activities which enables topline data readout in early 2024, maintaining the timing of our planned NDA submission in the first half of 2024. We are grateful and highly encouraged by the overwhelming interest in this trial from people living with HAE and, if approved, we look forward to introducing a novel therapeutic that offers the potential to transform the treatment of this disease.”
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