KalVista Operational Update and Fiscal Year Financial Results

 

• Sebetralstat Phase 3 KONFIDENT Clinical Trial Achieves Target Enrollment; Data Readout Expected in Q4
• Company Funded Into 2025 With NDA Planned for H1 2024

 KalVista Pharmaceuticals, Inc. (NASDAQ: KALV), a clinical stage pharmaceutical company focused on the discovery, development, and commercialization of oral, small molecule protease inhibitors, today provided an operational update and released financial results for the fiscal year ended April 30, 2023.

“We have made a great deal of progress over the last fiscal year in the development of sebetralstat,” said Andrew Crockett, Chief Executive Officer of KalVista. “Consistent with prior guidance, we have achieved the target enrollment for the sebetralstat phase 3 KONFIDENT trial. We expect to have data readout in the fourth quarter of this year and submit an NDA in the first half of 2024. In addition, we continue to expand the potential of our oral Factor XIIa inhibitor program beyond HAE by presenting positive preclinical data in several other therapeutic areas, including thrombosis. We remain well-capitalized, with funding into 2025.”

Fiscal 2023 and Recent Business Highlights:

Sebetralstat

• In June 2023, the Company achieved its enrollment target of 114 patients in the phase 3 KONFIDENT trial. KalVista expects data from the event-driven trial in the fourth quarter of 2023 and, if successful, anticipates submitting an NDA to the FDA in the first half of 2024.
• Presented real-world patient data at the 13^th C1-inhibitor Deficiency & Angioedema Workshop and the 2023 Meeting of the European Academy of Allergy and Clinical Immunology (EAACI) showing the persistent burden in patients receiving modern long-term prophylaxis, and the challenges associated with on-demand treatment decision-making during HAE attacks.
• Received guidance from the Japanese regulatory authority (PMDA) on the clinical development pathway to a regulatory submission in that country. KONFIDENT is the first pivotal phase 3 global trial in HAE to include Japanese sites and patients.
• Published sebetralstat phase 2 data evaluating the efficacy and safety of oral sebetralstat for the on-demand treatment of hereditary angioedema (HAE) attacks in The Lancet.
• Reported positive phase 1 data for an oral disintegrating tablet (ODT) formulation of sebetralstat. KalVista also received FDA feedback on its proposed ODT development program to support a supplemental NDA, which did not include a requirement to conduct efficacy trials.
• Initiated KONFIDENT-S, a two-year open-label extension trial assessing the long-term safety and tolerability profile of sebetralstat. The study will also examine the potential use of sebetralstat as a treatment for short-term prophylaxis in medical and dental procedures.

Oral Factor XIIa Inhibitor Program

• Reported promising preclinical data for the Company’s oral factor XIIa inhibitor program at the 2023 Congress of The International Society on Thrombosis and Haemostasis (ISTH). Data showed that KalVista’s potent and selective FXIIa inhibitor with high oral availability inhibited thrombosis in mice, the first oral FXIIa inhibitor shown to protect against thrombosis.

https://www.biospace.com/article/kalvista-pharmaceuticals-provides-operational-update-and-fiscal-year-financial-results-july-07-2023/