KalVista Pharmaceuticals Gives Operational Update on Potential HAE Medicine

KalVista Pharmaceuticals, Inc., a clinical-stage pharmaceutical company, provided an operational update and released financial results for the first fiscal quarter ended July 31, 2023.

Andrew Crockett, Chief Executive Officer of KalVista, said: “We know from our extensive interactions with people living with hereditary angioedema (HAE) at the recent conferences how much they are anticipating having sebetralstat available to them, and the data from the KONFIDENT trial in Q4 is the next step.

“We continue to build our Commercial operation with the addition of Nicole Sweeny as Chief Commercial Officer and other key members of the team to support an NDA submission in the first half of 2024 and a rapid launch upon FDA approval.”

Relevant business highlights include:

  • Published “Evaluation of patient-reported outcome measures for on-demand treatment of hereditary angioedema attacks and design of KONFIDENT, a phase 3 trial of sebetralstat” in Clinical and Translational Allergy. This publication outlines the rigorous, multi-factorial approach used to design a phase 3 trial with an optimized, patient- and physician-preferred measure to assess measure efficacy and discusses reasons for the superiority of the selected primary endpoint over other potential measures
  • Presented real-world patient data on the HAE Attack Journey at the HAEi Regional Conference EMEA meeting, showing there remain important unmet needs for both people using only on-demand therapies as well as those on long-term prophylaxis
  • Achieved enrollment target of 114 patients in the phase 3 KONFIDENT trial. Data readout remains on track for the fourth quarter of 2023, and if the trial is successful, KalVista anticipates submitting an NDA to the FDA in the first half of 2024
  • Presented real-world patient data at the 2023 US HAEA National Summit showing people living with HAE continue to delay treatment for attacks due to challenges from injections or infusions, even though they know early treatment means an earlier return to normal activities
  • Revealed patient survey data at the 13th C1-inhibitor Deficiency & Angioedema Workshop demonstrating the burden associated with injectable on-demand treatments for HAE and that those living with HAE had a strong preference for oral medication for on-demand treatment of attacks over self-administered injectable treatments when efficacy and safety profiles were similar
  • Continued to advance plans for the eventual worldwide launch of sebetralstat by hiring a General Manager, Japan. Based on interactions to date with Japanese physicians and regulatory authorities, KalVista believes sebetralstat has the potential to significantly improve HAE therapeutic options in Japan.

(Source: KalVista Pharmaceuticals Inc)