– Phase 1 data provide rationale for sebetralstat as short-term prophylaxis for medical and dental procedures -
– Patient survey data demonstrate treatment burden associated with injectable on-demand treatments for HAE -
KalVista Pharmaceuticals, Inc. (NASDAQ: KALV), a clinical stage pharmaceutical company focused on the discovery, development, and commercialization of oral, small molecule protease inhibitors, announced today that it made two oral presentations and one poster presentation at the 13th C1-inhibitor Deficiency & Angioedema Workshop (C1 Workshop) in Budapest, Hungary.
The following presentations occurred at the 2023 C1 Workshop:
- Rationale for the Short-term Prophylaxis Regimen with Sebetralstat in KONFIDENT-S: Michael D. Smith, KalVista Pharmaceuticals Inc., Cambridge, MA, USA (oral presentation)
- HAE Patients Decision to Carry On-demand Treatment When Away from Home: Stephen Betschel, Division of Allergy and Immunology, Department of Medicine, St. Michael's Hospital, University of Toronto, Toronto, ON Canada (oral presentation)
- Route of Administration Preferences of People with Hereditary Angioedema for On-demand Treatment: A US-based Qualitative Study: Laurence Bouillet, Internal Medicine, Grenoble Alpes University, National Reference Center for Angioedema, Grenoble, France (poster presentation)
In the first oral presentation, KalVista presented data providing the rationale for the sebetralstat regimen for short-term prophylaxis (STP) for medical and dental procedures in people living with hereditary angioedema (HAE) in the phase 3 KONFIDENT-S trial, which is an ongoing, up to 2-year, open-label extension of the phase 3 KONFIDENT trial.
The second oral presentation was based on real-world survey data collected from people with HAE and showed that only one-third of patients always carry on-demand attack treatment with them when away from home. Of note, those that did not carry treatment would routinely travel for several hours without it for a variety of reasons, including a preference to treat with injectables at home.
The poster presentation, based on qualitative interviews with adolescents and adults with HAE, demonstrated that both groups 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.
“The data we have gathered from a comprehensive survey focused on the experience of patients experiencing HAE attacks has been eye-opening and reveals the real-world impact injectable treatments have on the lives of people living with HAE,” said Andrew Crockett, Chief Executive Officer of KalVista. “Strong patient preference data for oral treatments over injectables reflects these challenges. We believe that sebetralstat may have the potential to improve patients’ current treatment experience. Given the challenges with access to and logistics surrounding the use of injectables for short-term prophylaxis prior to routine medical and dental procedures, the oral regimen being assessed in KONFIDENT-S may represent yet another opportunity to enhance the lives of people living with HAE.”
Links to all posters and oral presentations can be found on the KalVista website under “Publications”.
About KalVista Pharmaceuticals, Inc.
KalVista Pharmaceuticals, Inc. is a pharmaceutical company focused on the discovery, development, and commercialization of oral, small molecule protease inhibitors for diseases with significant unmet need. KalVista is developing sebetralstat as an oral on-demand therapy for HAE attacks and is enrolling the Phase 3 KONFIDENT clinical trial. In addition, KalVista’s oral Factor XIIa inhibitor program represents a new generation of therapies that may further improve the treatment for people living with HAE and other diseases.
For more information about KalVista, please visit www.kalvista.com.
For more information on the sebetralstat HAE on-demand Phase 3 KONFIDENT study, please visit www.konfidentstudy.com.
This press release contains "forward-looking" statements within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: "anticipate," "intend," "plan," "goal," "seek," "believe," "project," "estimate," "expect," "strategy," "future," "likely," "may," "should," "will" and similar references to future periods. These statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from what we expect. Examples of forward-looking statements include, among others, timing or outcomes of communications with the FDA, our expectations about safety and efficacy of our product candidates and timing of clinical trials and its results, our ability to commence clinical studies or complete ongoing clinical studies, including our Phase 3 KONFIDENT trial, and to obtain regulatory approvals for sebetralstat and other candidates in development, the success of any efforts to commercialize sebetralstat, the ability of sebetralstat and other candidates in development to treat HAE or other diseases, and the future progress and potential success of our oral Factor XIIa program. Further information on potential risk factors that could affect our business and financial results are detailed in our filings with the Securities and Exchange Commission, including in our annual report on Form 10-K for the year ended April 30, 2022, our quarterly reports on Form 10-Q, and our other reports that we may make from time to time with the Securities and Exchange Commission. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.
KalVista Pharmaceuticals, Inc.
Vice President, Corporate Communications