CAMBRIDGE, Mass. & SALISBURY, England--(BUSINESS WIRE)--KalVista Pharmaceuticals, Inc. (NASDAQ: KALV), a clinical stage pharmaceutical company focused on the discovery, development, and commercialization of oral, small molecule protease inhibitors, today announced the presentation of a novel analysis characterizing hereditary angioedema (HAE) attacks occurring in patients receiving long-term prophylaxis (LTP) treatments at the Asia Pacific Association of Allergy, Asthma and Clinical Immunology 2023 International Conference (APAAACI) in Singapore.
A systematic literature review of interventional and observational LTP studies revealed that although LTP yields significant reductions in HAE attack frequency, many patients continue to experience attacks in all anatomic locations, including potentially life-threatening laryngeal attacks. In randomized controlled trials, long-term (≥6 months) attack-free rates are low (<45%) with pdC1-INH, berotralstat, danazol, and tranexamic acid, and are generally higher with lanadelumab (44% for lanadelumab 300 mg Q2W [77% in a post hoc analysis from Day 70 to Day 182]).
“As highlighted in HAE clinical practice guidelines, the goal of LTP is to achieve full control of disease burden. However, this systematic review of LTP treatment studies shows that attack-free rates are lower than perceived, and therefore, substantial disease burden remains for many people living with HAE,” said Andrew Crockett, Chief Executive Officer of KalVista. “Access to safe and effective on-demand therapy is essential for all people living with HAE, including those receiving LTP. Sebetralstat, an oral plasma kallikrein inhibitor in late-stage development for on-demand treatment of HAE attacks, has the potential to address this persisting unmet need.”
The following presentations occurred at APAAACI 2023:
- Hereditary Angioedema Attacks in Patients Receiving Long-Term Prophylaxis: A Systematic Review: Hilary J. Longhurst, Auckland City Hospital, Te Toka Tumai, and University of Auckland, Auckland, New Zealand
- KONFIDENT Phase 3 Trial Global Expansion: Sebetralstat Pharmacokinetics and Pharmacodynamics in Japanese and Chinese Adults: Daisuke Honda, Chiba University Graduate School of Medicine, Chiba, Japan
Links to all posters and 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 has achieved target enrollment for 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.
Forward-Looking Statements
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, 2023, 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.
