KalVista Pharmaceuticals Presents Data at American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting

Rhea-AI Summary

KalVista Pharmaceuticals presented five posters at the 2023 AAAAI Annual Meeting in San Antonio, Texas, showcasing key findings related to sebetralstat, an oral treatment for Hereditary Angioedema (HAE). The research indicates that orally disintegrating tablets display similar pharmacokinetics to existing film-coated tablets, which supports potential lifecycle extensions in the US and EU. Data also illustrate the treatment burden of injectable therapies, with an emphasis on the advantages of sebetralstat. Notably, Phase 2 trial results show that early treatment can significantly lower attack severity and cumulative symptom burden compared to placebo.

Positive

• Orally disintegrating tablet formulation shows similar pharmacokinetics to film-coated tablets, supporting lifecycle extension.
• Phase 2 trial results demonstrate early treatment with sebetralstat reduces cumulative symptom severity of HAE attacks.

Negative

• None.

– Orally disintegrating tablet formulation shows similar pharmacokinetics to current film-coated tablets supporting lifecycle extension in US and EU -

– Real-word evidence and patient survey data demonstrate treatment burden associated with the administration of injectable on-demand treatments in HAE -

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 presented five posters at the American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting in San Antonio, Texas.

The following presentations occurred at the 2023 AAAAI Annual Meeting:

• A comparative bioavailability of sebetralstat following administration of orally disintegrating tablets and film-coated tablets in healthy volunteers: Michael D. Smith, KalVista Pharmaceuticals Inc., Cambridge, MA, USA
• Reporting of Adverse Drug Reactions with Parenteral Drugs for the On-Demand Treatment of Hereditary Angioedema Attacks – Analysis of the FAERS Database 2009 to 2022: Dr. Raffi Tachdjian, UCLA School of Medicine, Los Angeles, CA, USA
• Anxiety Associated With Parenteral On-Demand Treatment For Hereditary Angioedema (HAE): Dr. Autumn Burnette, Division of Allergy and Immunology, Howard University Hospital, Washington, DC, USA
• Patient Perspectives On Early Use Of On-Demand Treatment For Hereditary Angioedema (HAE) Attacks to Reduce Severity and Duration: Dr. Cristine Radojicic, Division of Pulmonary, Allergy and Critical Care, Duke University Medical Center, Durham, North Carolina, USA
• Treatment with Sebetralstat Reduces the Cumulative Symptom Severity of Hereditary Angioedema Attacks in a Phase 2 Trial: Dr. Jonathan A. Bernstein, University of Cincinnati College of Medicine and Bernstein Clinical Research Center, LLC, Cincinnati, OH, USA

“The real-world data presented at AAAAI highlight the significant treatment burden and anxiety associated with existing injectable on-demand therapies, and the potential for sebetralstat, an investigational oral plasma kallikrein inhibitor, to improve the treatment experience for people living with HAE,” said Andrew Crockett, Chief Executive Officer of KalVista. “Additionally highlighting this potential are the data from our phase 2 trial assessing sebetralstat for on-demand of HAE attacks demonstrating that early treatment decreased cumulative attack and symptom severity compared to placebo, as well as new data supporting continued advancement of our orally disintegrating tablet formulation.”

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.

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, 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20230227005338/en/

KalVista Pharmaceuticals, Inc.

Jarrod Aldom

Vice President, Corporate Communications

(201) 705-0254

jarrod.aldom@kalvista.com

Source: KalVista Pharmaceuticals, Inc.

FAQ

What did KalVista Pharmaceuticals present at the 2023 AAAAI Annual Meeting?

KalVista Pharmaceuticals presented five posters highlighting findings on sebetralstat, an oral treatment for Hereditary Angioedema.

What are the benefits of sebetralstat based on the new data?

The new data suggest that sebetralstat may reduce treatment burden compared to injectable therapies and decrease cumulative symptom severity in HAE attacks.

What is the significance of the orally disintegrating tablet for sebetralstat?

The orally disintegrating tablet shows similar pharmacokinetics to current film-coated tablets, supporting its potential lifecycle extension.

What were the findings from the Phase 2 trial of sebetralstat?

The Phase 2 trial showed that early treatment with sebetralstat significantly decreased cumulative attack and symptom severity compared to placebo.