CAMBRIDGE, Mass. & SALISBURY, England, September 26, 2024--(BUSINESS WIRE)--KalVista Pharmaceuticals, Inc. (NASDAQ: KALV), today announced the acceptance of multiple abstracts at the HAEi Global Angioedema Forum (GAF) taking place in Copenhagen, Denmark October 4-5, 2024.
The following nine abstracts have been accepted for poster presentation on Friday, October 4 between 6:00-7:00pm CET:
Impact of Oral Sebetralstat on Anxiety Associated with Hereditary Angioedema Attacks in the Phase 3 KONFIDENT Trial: Marcus Maurer, Danny M. Cohn, Jonathan A. Bernstein, Henriette Farkas, William R. Lumry, Marc A. Riedl, Andrea Zanichelli, James Hao, Michael D. Smith, Paul K. Audhya, Chris Yea, Emel Ayg?ren-Pürsün
Anxiety Associated with Parenteral On-Demand Treatment for Hereditary Angioedema Attacks: Andrea Zanichelli, Pietro Accardo, Francesco Arcoleo, Donatella Bignardi, Caterina Colangelo, Francesco Giardino, Antonio Gidaro, Marica Giliberti, Maria Domenica Guarino, Paola Lucia Minciullo, Stefania Nicola, Francesca Perego, Riccardo Senter, Giuseppe Spadaro, Paola Triggianese, Massimo Triggiani, Sherry Danese, Julie Ulloa, Vibha Desai, Tomas Andriotti, Paul Audhya, Mauro Cancian
The Hereditary Angioedema (HAE) Attack Journey: A Conceptual Model of Patient Anxiety and On-Demand Treatment Burden During an HAE Attack:Douglas Jones, Hilary Longhurst, Mar Guilarte, Sally van Kooten, Neil Malloy, Markus Heckmann, Emily Carne
Impact of Delayed Treatment of Hereditary Angioedema Attacks on Quality of Life and Ability to Work:Patrick Yong, Rashmi Jain, Tomaz Garcez, Sorena Kiani-Alikhan, Vibha Desai, Tomas Andriotti, Paul Audhya, Sherry Danese, Julie Ulloa, Tariq El-Shanawany, Padmalal Gurugama, Sinisa Savic
Impact of Hereditary Angioedema Attacks on Quality of Life and Ability to Work Among UK Patients Receiving Long-term Prophylaxis or On-demand Treatment Only: Sinisa Savic, Tariq El-Shanawany, Padmalal Gurugama, Rashmi Jain, Vibha Desai, Tomas Andriotti, Paul Audhya, Sherry Danese, Julie Ulloa, Tomaz Garcez, Sorena Kiani-Alikhan, Patrick Yong
Phase 3 KONFIDENT Trial of Oral Sebetralstat for Treatment of Hereditary Angioedema Attacks: Analysis of the European and US Patient Subgroups:Andrea Zanichelli, Emel Ayg?ren-Pürsün, Jonathan A. Bernstein, Henriette Farkas, William R. Lumry, Marcus Maurer, Marc A. Riedl, James Hao, Michael Smith, Paul Audhya, Chris Yea, Danny Cohn
Patient-Reported Benefits of Early On-demand Treatment of HAE Attacks:Mar Guilarte, Hilary Longhurst, Sally van Kooten, Neil Malloy, Markus Heckmann, Paula Busse
Treatment of HAE Attacks with Anticipated Future Oral On-demand Therapies as Reported by Patients:Anna Valerieva, Douglas Jones, Sally van Kooten, Neil Malloy, Markus Heckmann, Stephen Betschel
Global Frequency and Diagnosis of Hereditary Angioedema with Normal C1INH: A Real World ACARE Survey:Markus Magerl, Marc A. Riedl, Sherry Danese, Julie Ulloa, Paul K. Audhya, Marcus Maurer
About Sebetralstat Discovered and developed entirely by the scientific team at KalVista, sebetralstat is a novel, investigational oral plasma kallikrein inhibitor for the on-demand treatment of hereditary angioedema (HAE). Sebetralstat received Fast Track and Orphan Drug Designations from the U.S. FDA, as well as Orphan Drug Designation and an approved Pediatric Investigational Plan from the European Medicines Agency (EMA).
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 location affected. All currently approved on-demand treatment options require either intravenous or subcutaneous administration.
About KalVista Pharmaceuticals, Inc. KalVista Pharmaceuticals, Inc. is a global pharmaceutical company focused on the development and delivery of oral medicines for diseases with significant unmet need. KalVista announced positive phase 3 data from the KONFIDENT trial for its oral, on-demand therapy, sebetralstat for HAE in February 2024. The Company’s NDA for sebetralstat has been accepted by the FDA with a PDUFA goal date of June 17, 2025. KalVista received validation of its MAA from the EMA in August 2024. KalVista expects to file for approval in the UK, Japan, and other countries later in 2024.
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.
