– Delays in treating attacks lead to increased anxiety, quality of life issues, higher frequency of returning attacks, and suboptimal clinical outcomes in both on-demand and prophylaxis patients –
CAMBRIDGE, Mass. & SALISBURY, England–(BUSINESS WIRE)–$KALV–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 multiple analyses of the relationship between the time to attack treatment and the effects delays in treatment have on clinical outcomes of people living with hereditary angioedema (HAE) at the 2024 HAEi Regional Conference Americas that took place in Panama City, Panama.
“These data show once again that people living with HAE still face challenges in following established guidelines for treating their attacks,” said Ben Palleiko, Chief Executive Officer of KalVista. “Even short treatment delays can lead to worse clinical outcomes, and despite efficacious on-demand treatments, the fact that they need to be injected results in barriers which lead to significant underuse and resultant overuse of long-term prophylaxis. If approved, sebetralstat should enable improved compliance with these guidelines, which has the potential to help people with HAE to better control their disease with a lower overall burden of treatment.“
The following presentations occurred at the 2024 HAEi Regional Conference Americas:
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Relationship Between Time to On-demand Treatment and Quality of Life During Hereditary Angioedema Attacks: Sandra Christiansen, University of California San Diego, La Jolla, CA, United States (Oral Presentation)
- Treatment delays are associated with lower QoL and poorer general health during HAE attack, emphasizing the benefits of compliance with HAE guidelines and greater awareness of the impact of delayed treatment on QoL
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Characterizing the Negative Impact of Delayed On-Demand Treatment of HAE Attacks: Ricardo Zwiener, Servicio de Alergia e Inmunología Clínica, Hospital Universitario Austral, Pilar, Buenos Aires, Argentina (Poster Presentation)
- The time to feeling in control of an HAE attack and time to feeling fully recovered were shorter for patients treating HAE attacks in <1 hour versus those who waited ≥1 hour
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Anxiety Associated with Refilling On-demand Therapy for HAE Attacks Contributes to Treatment Delay and Non-Treatment: Anete S. Grumach, Clinical Immunology, Faculdade de Medicina, Centro Universitario FMABC, Santo Andre, Brazil (Poster Presentation)
- Anxiety associated with not being able to refill on-demand treatment impacted treatment decisions, which contributed to treatment delay or resulted in non-treatment of HAE attacks
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Treatment Patterns of Patients Requiring Redosing of an On-demand Treatment After the Return of an HAE Attack: William Lumry, Allergy and Asthma Research Associates, Dallas, Texas, United States. (Poster Presentation)
- HAE attacks initially treated within 1 hour returned less frequently compared with attacks treated at 1 hour or longer
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Anxiety Associated with On-Demand Treatment for Hereditary Angioedema (HAE) Attacks: Maeve O’Connor, Allergy, Asthma, & Immunology Relief of Charlotte, Charlotte, NC, United States (Poster Presentation)
- Both adults and adolescents with HAE reported moderate to extreme anxiety when anticipating use of parenteral on-demand treatment, irrespective of use of on-demand only or on-demand plus LTP
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Characteristics of Hereditary Angioedema Attacks Among Long-Term Prophylaxis Users: Maeve O’Connor, Allergy, Asthma, & Immunology Relief of Charlotte, Charlotte, NC, United States (Poster Presentation)
- Among HAE patients who had treated a recent attack, the location and duration of the most recent attacks were similar between long-term prophylaxis (LTP) and on-demand only users
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 disclosed positive phase 3 data for the KONFIDENT trial for its oral, on-demand therapy sebetralstat in February 2024. The Company anticipates submitting a new drug application to the U.S. FDA for sebetralstat in the first half of 2024 and expects to file for approval in Europe and Japan later in 2024. 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.
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 their results, our ability 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.
Contacts
KalVista Pharmaceuticals, Inc.
Jarrod Aldom
Vice President, Corporate Communications
(201) 705-0254
jarrod.aldom@kalvista.com
Ryan Baker
Head, Investor Relations
(617) 771-5001
ryan.baker@kalvista.com