KalVista Pharmaceuticals, Inc. (NASDAQ: KALV), a clinical-stage pharmaceutical company specializing in the discovery, development, and commercialization of oral, small molecule protease inhibitors, has announced today that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted the Innovation Passport for sebetralstat. Sebetralstat is an investigational novel, oral plasma kallikrein inhibitor intended for the on-demand treatment of hereditary angioedema (HAE). The Innovation Passport marks the initial stage in the UK’s Innovative Licensing and Access Pathway (ILAP), aimed at expediting a product’s route to market and facilitating patient access to innovative medicines.
Andrew Crockett, Chief Executive Officer of KalVista, stated, “As a company with its origins in the UK, we are delighted to receive the ILAP designation, which will enable us to further expedite our regulatory submission for sebetralstat. We eagerly anticipate collaborating with the MHRA and other health regulatory agencies globally as we strive to introduce the first oral, on-demand treatment to individuals living with HAE.”
KalVista recently disclosed topline phase 3 data for sebetralstat, demonstrating clinically and statistically significant results across all endpoints, alongside an excellent safety and tolerability profile. The Company is set to present late-breaking KONFIDENT trial data on February 25, 2024, at the upcoming American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting.
