– Sebetralstat pharmacokinetic and pharmacodynamic data support globalization of the KONFIDENT phase 3 clinical trial and use in short-term prophylaxis –
– Real-world patient data show significant burden from HAE still remains on patients receiving modern long-term prophylaxis and challenges associated with treatment decisions –
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 that it presented data on sebetralstat and quality of life issues experienced by people living with hereditary angioedema (HAE) at the 2023 Meeting of the European Academy of Allergy and Clinical Immunology (EAACI) in Hamburg, Germany.
The following presentations occurred at EAACI 2023:
- Results From a Randomized, Double-Blind, Placebo-Controlled, Phase 1 Trial Evaluating Sebetralstat Pharmacokinetics, Pharmacodynamics, and Safety/Tolerability in Healthy Japanese, Chinese, and White Adults: Michihiro Hide, Hiroshima City Hiroshima Citizens Hospital, Hiroshima, Japan (Flash Talk)
- Short-Term Prophylaxis with Sebetralstat, an Investigational Oral On-Demand Treatment for Hereditary Angioedema, in KONFIDENT-S: Jonathan A. Bernstein, University of Cincinnati College of Medicine and Bernstein Clinical Research Center, LLC, Cincinnati, OH, US (Poster Presentation)
- Remaining burden of hereditary angioedema (HAE) attacks despite modern long-term prophylaxis: Stephen Betschel, Division of Allergy and Immunology, Department of Medicine, St. Michael's Hospital, University of Toronto, Toronto, ON Canada (Flash Talk)
- Understanding the complex decision-making associated with on-demand treatment of hereditary angioedema (HAE) attacks: Anete Grumach, Centro Universitário Faculdade de Medicina do ABC (FMABC), Santo André, Brazil (Poster Presentation)
- Patients delay treating hereditary angioedema (HAE) attacks with currently available, injectable, on-demand therapies: associated with on-demand treatment of hereditary angioedema (HAE) attacks: Anna Valerieva, Medical University of Sofia, Sofia, Bulgaria (Poster Presentation, also selected for the EAACI Junior Member Poster Session)
The first presentation highlighted consistencies in pharmacokinetics and pharmacodynamics for sebetralstat across healthy Japanese, Chinese and White adult populations, supporting the continued global expansion of the ongoing KONFIDENT phase 3 trial assessing the efficacy and safety of sebetralstat for on-demand use in HAE attacks, while the second presentation outlines the rationale for sebetralstat as a potential treatment to prevent HAE attacks that may be triggered by invasive medical or dental procedures. KalVista is currently assessing sebetralstat as an oral, short-term prophylaxis in KONFIDENT-S, the two-year open-label extension study for the KONFIDENT phase 3 trial.
The remaining three presentations showed findings derived from a real-world patient survey of the HAE attack journey, which has not been well-described from a patient perspective until now. The first of these describes the persisting burden of HAE on patients in their attempt to live normally. Among the findings were that half of people with HAE on prophylaxis do not treat all of their HAE attacks with on-demand treatment and do not carry their on-demand treatment with them as advised by HAE treatment guidelines. The second and third presentations highlighted the challenges to patients making decisions on whether to treat attacks, and the reasons why they routinely delay treatment using current injectable therapies.
“The complexity of decision-making by patients associated with on-demand treatment of HAE attacks is under-appreciated, and greatly influences how they address those attacks with currently available, injectable, on-demand treatments,” said Andrew Crockett, Chief Executive Officer of KalVista. “We also see that even in the context of modern prophylaxis, there remains a significant persisting burden for people living with HAE. These findings highlight gaps in the existing HAE treatments and potentially position sebetralstat to address these unmet needs in this therapeutic landscape.”
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 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.