CAMBRIDGE, Mass. & SALISBURY, England, May 22, 2025--(BUSINESS WIRE)--KalVista Pharmaceuticals, Inc. (Nasdaq: KALV) today announced that it will present new sebetralstat data at two upcoming congresses taking place concurrently from May 29–June 1, 2025: the 14th C1-inhibitor Deficiency & Angioedema Workshop in Budapest, Hungary, and the Eastern Allergy Conference (EAC) in Palm Beach, Florida. The presentations will include new findings on the potential of sebetralstat to rapidly relieve symptoms and halt progression of hereditary angioedema (HAE) attacks, including mucosal and severe cases, underscoring the importance of early intervention and the role of an oral on-demand treatment option. Details of the presentations are as follows:
C1-inhibitor Deficiency & Angioedema Workshop
The following poster presentations will take place during Poster Session I on Friday, May 30, from 3:45–5:30 pm CEST (9:45–11:30 am ET):
In their own words, patient perspectives on time to feeling in control of an HAE attack (P-18): Doug Jones, Anna Valerieva, Mar Guilarte, Neil Malloy, Sally van Kooten, Markus Heckmann, Markus Magerl.
Time to end of progression of hereditary angioedema attacks treated with sebetralstat (P-25): William R. Lumry, John Anderson, Jonathan A. Bernstein, Mauro Cancian, Danny M. Cohn, Henriette Farkas, Henry Li, James Hao, Michael Smith, Paolo Bajcic, Paul Audhya, Markus Magerl.
Impact of injectable HAE on-demand treatments on health-related quality of life: a patient and caregiver interview study (P-29): Patrick Yong, Aleena Banerji, Paula Busse, Timothy Craig, Sorena Kiani-Alikhan, Rebekah Hall, Siu Hing Lo, Caleb Dixon, Paul Audhya, Alice Wang, Tomaz Garcez.
The following oral presentation will take place during Scientific Session III on Saturday, May 31, from 2:30–2:45 pm CEST (8:30–8:45 am ET):
Effectiveness of sebetralstat for the on-demand treatment of mucosal hereditary angioedema attacks: interim analysis from KONFIDENT-S (O-29): Jonathan A. Bernstein, Emel Aygören-Pürsün, Vesna Grivcheva-Panovska, Inmaculada Martinez-Saguer, Danny M. Cohn, William R. Lumry, Marc A. Riedl, Andrea Zanichelli, Laurence Bouillet, Ya-Hsiu Chuang, Michael D. Smith, Christopher M. Yea, Paul K. Audhya, Henriette Farkas.
The following oral presentation will take place during Scientific Session V on Saturday, May 31, from 3:15–3:30 pm CEST (9:15–9:30 am ET):
Anxiety associated with hereditary angioedema attacks: results from the phase 3 KONFIDENT trial of oral sebetralstat (O-32): Timothy J. Craig, Emel Aygören-Pürsün, Jonathan A. Bernstein, Paula J. Busse, Teresa Caballero, Danny M. Cohn, Mar Guilarte, Henriette Farkas, Douglas H. Jones, Sorena Kiani-Alikhan, Michael E. Manning, Marcus Maurer, Marc A. Riedl, Sinisa Savic, H. James Wedner, Patrick F. K. Yong, Andrea Zanichelli, Erik Hansen, James Hao, Michael D. Smith, Christopher M. Yea, Paul K. Audhya, William R. Lumry.
The following poster presentation will take place during Poster Session II on Saturday, May 31, from 4:15–5:45 pm CEST (10:15–11:45 am ET):
Survey results from Italy, the US, UK, and France: Anxiety in patients using injectable on-demand treatments for hereditary angioedema attacks (P-32):Mauro Cancian, Alexis Bocquet, Paula J. Busse, Timothy Craig, Tariq El-Shanawany, Tomaz Garcez, Padmalal Gurugama, Rashmi Jain, Sorena Kiani-Alikhan, Maeve O’Connor, Cristine Radojicic, Sinisa Savic, Paola Triggianese, H. James Wedner, Patrick Yong, Andrea Zanichelli, Vibha Desai, Julie Ulloa, Sherry Danese, Paul K. Audhya, Sandra Christiansen.
KalVista is also sponsoring a pre-workshop symposium for healthcare professionals on Thursday, May 29, from 1:00–2:00 pm CEST (7:00–8:00 am ET) in the Magnolia room, titled "Interplay Between On-Demand Treatment Guidelines and Clinical Trials in HAE." Chaired by Dr. William Lumry, Clinical Professor of Internal Medicine at the University of Texas Southwestern Medical School and Medical Director of AARA Research Center, this symposium will highlight insights from Dr. Mauro Cancian (University Hospital of Padova, Italy) and Dr. Danny Cohn (University of Amsterdam, Netherlands), addressing the evolution of on-demand treatment guidelines in HAE, real-world challenges in guideline adherence, and advancements in clinical trial designs to support guideline adherence.
EAC
The following poster presentations will take place on Saturday, May 31, from 9:45–11:00 am ET:
Effectiveness of Sebetralstat for Severe or Very Severe Hereditary Angioedema Attacks in KONFIDENT-S:Henry Li, William R. Lumry, Michael E. Manning, Marc A. Riedl, James Wedner, James Hao, Michael D. Smith, Paul K. Audhya, Jonathan A. Bernstein.
On-demand Treatment of Hereditary Angioedema Attacks with Sebetralstat in Older Adults: Interim Analysis from KONFIDENT-S: Daniel F. Soteres, Alan P. Baptist, Jonathan A. Bernstein, Timothy Craig, William R. Lumry, James Hao, Michael D. Smith, Paolo Bajcic, Paul K. Audhya, Marc A. Riedl.
Time to End of Progression of Hereditary Angioedema Attacks Treated with Sebetralstat: Daniel F. Soteres, William R. Lumry, John Anderson, Jonathan A. Bernstein, Mauro Cancian, Danny M. Cohn, Henriette Farkas, Henry Li, James Hao, Michael D. Smith, Paolo Bajcic, Paul K. Audhya, Markus Magerl.
Long-Term Prophylaxis Compliance and Healthcare Resource Utilization in Hereditary Angioedema: A Claims Database Analysis: Raffi Tachdjian, Daniel F. Soteres, Maeve O'Connor, Chirag Maheshwari, Alice Wang, Paul K. Audhya, Timothy Craig.
Links to all presentations can be found on the KalVista website under Publications.
About Sebetralstat Sebetralstat is an investigational, novel oral plasma kallikrein inhibitor for the treatment of hereditary angioedema (HAE). We have filed multiple regulatory applications seeking approval of sebetralstat as the first oral, on-demand treatment for HAE in individuals aged 12 and older, with ongoing studies exploring its use in children aged 2 to 11. If approved, sebetralstat has the potential to become the foundational therapy for HAE management worldwide.
About Hereditary Angioedema Hereditary angioedema (HAE) is a rare genetic disease resulting in deficiency or dysfunction in the C1 esterase inhibitor (C1INH) protein and subsequent uncontrolled activation of the kallikrein-kinin system. People living with HAE experience painful and debilitating attacks of tissue swelling in various locations of the body that can be life-threatening depending on the area affected. All currently approved on-demand treatment options require either intravenous or subcutaneous administration.
About KalVista Pharmaceuticals, Inc. KalVista Pharmaceuticals, Inc., is a global biopharmaceutical company dedicated to developing and delivering life-changing oral therapies for individuals affected by rare diseases with significant unmet needs. Our lead investigational product is sebetralstat, a novel, oral, on-demand treatment for hereditary angioedema (HAE). Sebetralstat is under regulatory review by the U.S. FDA, with a PDUFA goal date of June 17, 2025. In addition, we have completed Marketing Authorization Applications for sebetralstat to the European Medicines Agency and multiple other global regulatory authorities.
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 KONFIDENT-S and KONFIDENT-KID trials, 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, 2024, 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.
