–New data show effectiveness of sebetralstat in reducing anxiety during attacks; supports need for oral on-demand option to treat attacks earlier and more often–
–Patient perspectives spotlight the prevalence of anxiety when faced with administering injectable on-demand therapies–
KalVista Pharmaceuticals, Inc. (NASDAQ: KALV), today announced that it presented data showing the effectiveness of sebetralstat in reducing anxiety among people experiencing hereditary angioedema (HAE) attacks at the HAEi Global Angioedema Forum (GAF) taking place in Copenhagen, Denmark, October 4 - 5, 2024. These data were generated in the KONFIDENT phase 3 clinical trial, for which the Company disclosed top line results in February 2024. Sebetralstat is a novel, investigational oral plasma kallikrein inhibitor for the on-demand treatment of HAE attacks in adults and adolescents aged 12 years and older.
KONFIDENT was the first randomized controlled trial to assess the impact of an on-demand treatment on anxiety associated with HAE attacks. This prespecified exploratoryanalysis was presented by Dr. William R. Lumry, AARA Research Center, Dallas, TX, USA and investigated attack-associated anxiety (in the absence of injectable therapy) in the phase 3 KONFIDENT trial and the impact of sebetralstat on anxiety, compared with placebo. Participants self-reported anxiety using a Modified Generalized Anxiety Numeric Rating Scale. Overall, anxiety was reduced among patients treated with sebetralstat 300mg (P=0.004 and P=0.022, respectively) and 600mg (P=0.0008 and P=0.0012) versus placebo. For participants with moderate-to-extreme anxiety, change from baseline at 4 hours was −2.8 (−3.6, −1.9) for each sebetralstat group and −1.3 (−2.2, −0.4) for placebo and at 12 hours was −3.5 (−4.3, −2.6) with sebetralstat 300mg, −4.3 (−5.2, −3.5) with 600mg, and −1.7 (−2.6, −0.8) with placebo. Notably, anxiety reduction was correlated with earlier time to beginning of symptom relief.
“The data presented at the Global Angioedema Forum highlights that people living with HAE often experience substantial anxiety when they have attacks, which reduces quality of life. In KONFIDENT, oral sebetralstat significantly reduced anxiety during attacks compared with placebo, especially among participants with moderate-to-extreme anxiety,” said William Lumry, M.D., Allergy and Asthma Research Associates, Dallas, Texas, United States. “If approved, sebetralstat has the potential to become an important option for people living with HAE who experience attack-related anxiety, enabling them to treat early and recover from their attacks sooner.”
Additional poster presentations at the HAEi Global Angioedema Forum 2024:
- Anxiety Associated with Parenteral On-Demand Treatment for Hereditary Angioedema Attacks: Riccardo Senter, Azienda Ospedaliera, Università degli Studi di Padova, Padova, Italy
- A substantial proportion of survey respondents experienced moderate to extreme anxiety due to anticipated use of on-demand treatment, particularly adolescents and those previously diagnosed with anxiety.
- Reasons for anxiety were most commonly related to treatment effectiveness, administration burden/side effects, and cost/access.
- Effective alternatives to current parenteral on-demand treatments are needed to address treatment-related anxiety associated with HAE attacks.
- The Hereditary Angioedema (HAE) Attack Journey: A Conceptual Model of Patient Anxiety and On-Demand Treatment Burden During an HAE Attack: Douglas Jones, Metrodora Institute, Salt Lake City, Utah
- The survey highlighted that people living with HAE experience anxiety when anticipating parenteral on-demand treatment.
- People with HAE often delay administering on-demand treatment with longer treatment delays reported by those feeling moderately to extremely anxious.
- Participants expressed that anxiety decreased once they began to recover from their attacks.
- Impact of Delayed Treatment of Hereditary Angioedema Attacks on Quality of Life and Ability to Work: Patrick Yong, Frimley Health NHS Foundation Trust, Frimley, United Kingdom
- Nearly all participants waited an hour or longer to treat their attacks and reported quality of life and work productivity were worse.
- Findings highlight the need for more education on treating at the earliest recognition of an attack and addressing barriers that contribute to treatment delays.
- 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: Patrick Yong, Frimley Health NHS Foundation Trust, Frimley, United Kingdom
- More than half of the total respondents were receiving long-term prophylaxis at the time of their most treated attack.
- 87% of respondents considered their attacks moderately severe to very severe.
- Those receiving parental on-demand treatment only and those receiving parental on-demand treatment plus LTP experienced substantial burden during their last treated HAE attack, in terms of physical, mental, and social QoL, as well as work productivity.
- Phase 3 KONFIDENT Trial of Oral Sebetralstat for Treatment of Hereditary Angioedema Attacks: Analysis of the European and US Patient Subgroups: Andrea Zanichelli, Operative Unit of Medicine, Angioedema Center, IRCCS Policlinico San Donato, San Donato Milanese, Milan, Italy; Department of Biomedical Sciences for Health, University of Milan, Milan, Italy (Poster presentation)
- In the KONFIDENT phase 3 clinical trial, the positive efficacy and safety of sebetralstat as an on-demand treatment for HAE was consistent between the European and U.S. subgroups.
- Patient-Reported Benefits of Early On-demand Treatment of HAE Attacks: Mar Guilarte, Allergy Department, Hospital Universitari Vall d'Hebron, Barcelona, Spain
- People living with HAE reported several positive benefits when treating attacks early with on-demand treatment: more likely than those who delayed treatment to carry their on-demand treatment with them, treat more attacks, feel less anxious when anticipating on-demand treatment, and recover more quickly from HAE attacks.
- Treatment of HAE Attacks with Anticipated Future Oral On-demand Therapies as Reported by Patients: Anna ValerievaDepartment of Allergology, Medical University of Sofia, Sofia, Bulgaria
- According to a survey of more than 100 participants, people living with HAE who are using parenteral on-demand treatment may treat more of their attacks and treat earlier with the availability of an oral on-demand treatment option.
- In addition, respondents noted they are less likely to experience anxiety when anticipating administration of an oral on-demand treatment.
- Global Frequency and Diagnosis of Hereditary Angioedema with Normal C1INH: A Real World ACARE Survey: Markus Magerl, Angioedema Center of Reference and Excellence (ACARE), Institute of Allergology, Charité – Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany; Fraunhofer Institute for Translational Medicine and Pharmacology ITMP, Immunology and Allergology, Berlin, Germany
- Due to varying clinical approaches, there are substantial delays in diagnosis of HAE for people with normal C1INH, which currently has no standardized diagnostic pathway.
- There is a need for evolved and consistent approaches to improve accurate diagnosis and clinical management of this patient population.
Links to all posters and presentations can be found on the KalVista website under Publications.
In Memoriam: KalVista would like to acknowledge and honor the memory of Prof. Marcus Maurer, Professor of Dermatology and Allergy, Executive Director of the Institute of Allergology at the Charité – Universitätsmedizin Berlin, and Co-Director of Allergology and Immunology at the Fraunhofer Institute for Translational Medicine and Pharmacology ITMP. Our thoughts remain with his family and the entire angioedema and urticaria community.
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 that seeks to develop and deliver oral medicines for diseases with significant unmet need. The Company is focused on understanding the needs of patients and the limitations of current therapies to design treatments that empower people to better manage their disease and improve their lives. KalVista’s NDA filing for sebetralstat for the on-demand treatment of hereditary angioedema (HAE) attacks has been accepted by the U.S. FDA with a PDUFA goal date of June 17, 2025. In addition, KalVista has received validation of its MAA for HAE from the EMA and has submitted MAA applications to regulators in the United Kingdom, Switzerland, Australia, and Singapore.
For more information about KalVista, please visit www.kalvista.com or follow on social media at @KalVista and LinkedIn.
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.
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