Publications Archive - KalVista Pharmaceuticals

Interplay of On-demand Trials for Hereditary Angioedema Attacks and Treatment Guidelines

Danny Cohn, Daniel Soteres, Timothy Craig, William Lumry, Markus Magerl, Marc Riedl, Paul Audhya, Marcus Maurer, Jonathan Bernstein

J Allergy Clin Immunol. 2025 Mar;155(3):726-739

Efficacy and Safety of Sebetralstat for On-demand Treatment of Hereditary Angioedema in Pooled Analysis of Placebo-controlled Clinical Trials

Mauro Cancian, Jonathan Bernstein, Danny Cohn, Henriette Farkas, William Lumry, Marc Riedl, Andrea Zanichelli, James Hao, Michael Smith, Christopher Yea, Paul Audhya, Emel Aygören-Pürsün, Sorena Kiani-Alikhan

Presented at Italian Network for Hereditary and Acquired Angioedema (ITACA) Meeting; March 27-29, 2025; Palermo, Italy

Effectiveness of Sebetralstat for the On-demand Treatment of Laryngeal Hereditary Angioedema Attacks: Interim Analysis from KONFIDENT-S

Jonathan Bernstein, Emel Aygören-Pürsün, Vesna Grivcheva-Panovska, Inmaculada Martinez-Saguer, Danny Cohn, William Lumry, Marc Riedl, Andrea Zanichelli, James Hao, Michael Smith, Christopher Yea, Paul Audhya, Henriette Farkas

Presented at American Academy of Allergy, Asthma, and Immunology/World Allergy Organization (AAAAI/WAO) Joint Conference; February 28-March 3, 2025; San Diego, California

On-demand Treatment Of Hereditary Angioedema Attacks With Sebetralstat In Adolescents: Pooled Analysis From KONFIDENT And KONFIDENT-S

Danny Cohn, Aharon Kessel, Tamar Kinaciyan, Rand Arnaout, Jonathan Peter, H James Wedner, Emel Aygören-Pürsün, Jonathan Bernstein, Henriette Farkas, William Lumry, Marcus Maurer, Marc Riedl, Andrea Zanichelli, James Hao, Matthew Iverson, Michael Smith, Christopher Yea, Paul Audhya, Fotios Psarros

Presented at American Academy of Allergy, Asthma, and Immunology/World Allergy Organization (AAAAI/WAO) Joint Conference; February 28-March 3, 2025; San Diego, California

Safety and Effectiveness of Sebetralstat in Patients with Hereditary Angioedema Receiving Long-term Prophylaxis: Interim Analysis from the KONFIDENT-S Open-label Study

Marc Riedl, Jonathan Bernstein, H Henry Li, Michael Manning, Jason Raasch, James Hao, Michael Smith, Paul Audhya, William Lumry

Presented at the Western Society of Allergy, Asthma & Immunology (WSAAI) Annual Meeting; February 9-13, 2025; Waimea, Hawaii

Sebetralstat for Treatment of Hereditary Angioedema Attacks in Patients Receiving Berotralstat: Interim Analysis from the KONFIDENT-S Open-label Study

Michael Manning, Marc Riedl, Raffi Tachdijan, H Henry Li, H James Wedner, Daniel Soteres, James Hao, Michael Smith, Paul Audhya, Tamar Kinaciyan

Presented at the Western Society of Allergy, Asthma & Immunology (WSAAI) Annual Meeting; February 9-13, 2025; Waimea, Hawaii

Efficacy and Safety of Sebetralstat for On-demand Treatment of Hereditary Angioedema in Pooled Analysis of Placebo-controlled Clinical Trials

Patrick Yong, Jonathan Bernstein, Danny Cohn, Henriette Farkas, William Lumry, Marc Riedl, Andrea Zanichelli, James Hao, Michael Smith, Christopher Yea, Paul Audhya, Emel Aygören-Pürsün, Sinisa Savic, Sorena Kiani-Alikhan

Presented at British Society for Immunology Clinical Immunology Professional Network (BSI-CIPN) Conference; December 9-10, 2024; Birmingham, United Kingdom

Correlation of Time to Treatment with Attack Duration in the Sebetralstat KONFIDENT Phase 3 Trial

Timothy Craig, Jonathan Bernstein, Hilary Longhurst, James Hao, Michael Smith, Paul Audhya, Christopher Yea, Marcus Maurer

Presented at American College of Allergy, Asthma, and Immunology (ACAAI) Conference; October 24-28, 2024; Boston, Massachusetts

Indirect Treatment Comparison of Oral Sebetralstat and Intravenous rhC1-INH as On-demand Treatments for Hereditary Angioedema

H Henry Li, Markus Magerl, Timothy Craig, Michael Manning, Noemi Hummel, Alice Wang, Paul Audhya, Jonathan Bernstein

Presented at American College of Allergy, Asthma, and Immunology (ACAAI) Conference; October 24-28, 2024; Boston, Massachusetts

On-demand Treatment of Laryngeal Hereditary Angioedema Attacks with Sebetralstat: Pooled Analysis from KONFIDENT and KONFIDENT-S

Emel Aygören-Pürsün, Jonathan Bernstein, William Lumry, Paul Audhya, James Hao, Michael Smith, Christopher Yea, Marc Riedl

Presented at American College of Allergy, Asthma, and Immunology (ACAAI) Conference; October 24-28, 2024; Boston, MA

Substantial Reduction of Hereditary Angioedema Attack Symptom Burden in the Sebetralstat Phase 3 KONFIDENT Trial

William Lumry, Danny Cohn, Jonathan Bernstein, Paul Audhya, James Hao, Michael Smith, Christopher Yea, Marc Riedl

Presented at American College of Allergy, Asthma, and Immunology (ACAAI) Conference; October 24-28, 2024; Boston, Massachusetts

Impact of Oral Sebetralstat on Hereditary Angioedema Attack-associated Anxiety: Analysis From the Phase 3 KONFIDENT Trial

Marcus Maurer, Danny Cohn, Jonathan Bernstein, Henriette Farkas, William Lumry, Marc Riedl, Andrea Zanichelli, James Hao, Michael Smith, Paul Audhya, Christopher Yea, Emel Aygören-Pürsün

Presented at the ACARE Global Angioedema Forum 2024; October 4-5, 2024; Copenhagen, Denmark

KONFIDENT Trial of Oral Sebetralstat for Treatment of Hereditary Angioedema Attacks: Analysis of the European and US Patient Populations

Andrea Zanichelli, Emel Aygören-Pürsün, Jonathan Bernstein, Henriette Farkas, William Lumry, Marcus Maurer, Marc Riedl, James Hao, Michael Smith, Paul Audhya, Christopher Yea, Danny Cohn

Presented at the ACARE Global Angioedema Forum 2024; October 4-5, 2024; Copenhagen, Denmark

Advent of Oral Medications for the Treatment of Hereditary Angioedema

Anna Valerieva, Teresa Caballero, Markus Magerl, Joao Frade, Paul Audhya, Timothy Craig

Clin Transl Allergy. 2024 Sep;14(9):e12391

KONFIDENT-S Interim Analysis: Sebetralstat for Hereditary Angioedema Attacks Including Laryngeal

Henriette Farkas, Marc Riedl, Emel Aygören-Pürsün, William Lumry, Andrea Zanichelli, James Hao, Matthew Iverson, Michael Smith, Christopher Yea, Paul Audhya, Jonathan Bernstein, Marcus Maurer, Danny Cohn

Presented at Bradykinin Symposium; September 4-6, 2024; Berlin, Germany

Pooled Sebetralstat Placebo-controlled Efficacy for On-demand Treatment of Hereditary Angioedema

Marcus Maurer, Jonathan Bernstein, Danny Cohn, Henriette Farkas, William Lumry, Marc Riedl, Andrea Zanichelli, James Hao, Matthew Iverson, Michael Smith, Christopher Yea, Paul Audhya, Sorena Kiani-Alikhan, Emel Aygören-Pürsün

Presented at Bradykinin Symposium; September 4-6, 2024; Berlin, Germany

Pooled Sebetralstat Placebo-controlled Safety for On-demand Treatment of Hereditary Angioedema

Emel Aygören-Pürsün, Jonathan Bernstein, Danny Cohn, Henriette Farkas, William Lumry, Marc Riedl, Andrea Zanichelli, Samuel Owiredu-Yeboa, James Hao, Michael Smith, Christopher Yea, Paul Audhya, Sorena Kiani-Alikhan, Marcus Maurer

Presented at Bradykinin Symposium; September 4-6, 2024; Berlin, Germany

Oral Sebetralstat for On-demand Treatment of Hereditary Angioedema Attacks

Marc Riedl, Henriette Farkas, Emel Aygören-Pürsün, Fotis Psarros, Daniel Soteres, Maria Staevska, Mauro Cancian, David Hagin, Daisuke Honda, Isaac Melamed, Sinisa Savic, Marcin Stobiecki, Paula Busse, Eunice Dias de Castro, Nancy Agmon-Levin, Richard Gower, Aharon Kessel, Marcin Kurowski, Ramon Lleonart, Vesna Grivcheva-Panovska, James Wedner, Paul Audhya, James Hao, Matthew Iverson, Michael Smith, Christopher Yea, William Lumry, Andrea Zanichelli, Jonathan Bernstein, Marcus Maurer, and Danny Cohn for the KONFIDENT Investigators

N Engl J Med. 2024 Jul 4;391(1):32-43

Sebetralstat as Oral On-demand Treatment for Hereditary Angioedema: Interim Analysis of the Open-label KONFIDENT-S Trial

Henriette Farkas, Marc Riedl, Emel Aygören-Pürsün, William Lumry, Andrea Zanichelli, James Hao, Matthew Iverson, Michael Smith, Christopher Yea, Paul Audhya, Jonathan Bernstein, Marcus Maurer, Danny Cohn

Presented at European Academy of Allergy & Clinical Immunology (EAACI) Congress; May 31 - June 3, 2024; Valencia, Spain

Sebetralstat for On-demand Treatment of Hereditary Angioedema Attacks: US Subgroup Analysis from the Double-blind, Placebo-controlled Phase 3 KONFIDENT Trial

Daniel Soteres, Marc Riedl, William Lumry, Paula Busse, James Hao, Matthew Iverson, Michael Smith, Christopher Yea, Paul Audhya, Jonathan Bernstein

Presented at the Eastern Allergy Conference (EAC); May 30 - June 2, 2024; Palm Beach, Florida

Sebetralstat: A Rapidly Acting Plasma Kallikrein Inhibitor for the On-demand Treatment of Hereditary Angioedema

Edward Feener, Rebecca Davie, Nivetha Murugesan, Stephen Pethen, Sally Hampton, Michael Smith, Paul Audhya, Christopher Yea

Drugs Drug Candidates 2024 Apr;3(2): 328-341

KONFIDENT Phase 3 Trial Global Expansion: Sebetralstat Pharmacokinetics and Pharmacodynamics in Japanese and Chinese Adults

Daisuke Honda, Matthew Iverson, Erik Hansen, Sally Hampton, Stanford Jhee, Esther Yoon, Paul Audhya, Michael Smith, Christopher Yea, Michihiro Hide

Presented at Asia Pacific Association of Allergy, Asthma and Clinical Immunology (APAAACI) International Conference; October 23-26, 2023; Singapore

Evaluation of Patient-reported Outcome Measures for On-demand Treatment of Hereditary Angioedema Attacks and Design of KONFIDENT, a Phase 3 trial of Sebetralstat

Danny Cohn, Emel Aygören-Pürsün, Jonathan Bernstein, Henriette Farkas, William Lumry, Marcus Maurer, Andrea Zanichelli, Matthew Iverson, James Hao, Michael Smith, Christopher Yea, Paul Audhya, Marc Riedl

Clin Transl Allergy. 2023 Sep;13(9):e12288

Results From a Randomized, Double-Blind, Placebo-Controlled, Phase 1 Trial Evaluating Sebetralstat Pharmacokinetics, Pharmacodynamics, and Safety/Tolerability in Healthy Japanese, Chinese, and White Adults

Michihiro Hide, Matthew Iverson, Stanford Jhee, Erik Hansen, Edward Duckworth, Sally Hampton, Esther Yoon, Daisuke Honda

Presented at European Academy of Allergy & Clinical Immunology (EAACI) Congress; June 9-11, 2023; Hamburg, Germany

Short-term Prophylaxis with Sebetralstat, an Investigational On-demand Treatment for Hereditary Angioedema, in KONFIDENT-S

Jonathan Bernstein, Marc Riedl, William Lumry, Paul Audhya, Michael Smith, Christopher Yea

Presented at European Academy of Allergy & Clinical Immunology (EAACI) Congress; June 9-11, 2023; Hamburg, Germany

Sebetralstat Effectiveness in the Treatment of Hereditary Angioedema Attacks Rated Mild or Moderate at Baseline in the Phase 2 Trial

Hilary Longhurst, Michael Smith, Christopher Yea, Paul Audhya

Presented at the Eastern Allergy Conference (EAC); June 1-4, 2023; Palm Beach, Florida

Rationale for the Short-term Prophylaxis Regimen with Sebetralstat in KONFIDENT-S

Matthew Iverson, Edward Duckworth, Erik Hanson, Sally Hampton, Michael Smith, Paul Audhya, Christopher Yea

Presented at 13th C1-Inhibitor Deficiency & Angioedema (C1-INH) Workshop; May 4-7, 2023; Budapest, Hungary

Comparative Bioavailability of Sebetralstat Following Administration of Orally Disintegrating Tablets and Film-Coated Tablets in Healthy Volunteers

Michael Smith, Matthew Iverson, Erik Hansen, Paul Audhya, Christopher Yea

Presented at American Academy of Allergy, Asthma, and Immunology (AAAAI) Conference; February 24-27, 2023; San Antonio, Texas

Treatment with Sebetralstat Reduces the Cumulative Symptom Severity of Hereditary Angioedema Attacks in a Phase 2 Trial

Jonathan Bernstein, Marc Riedl, William Lumry, Paul Audhya, Michael Smith, Christopher Yea

Presented at American Academy of Allergy, Asthma, and Immunology (AAAAI) Conference; February 24-27, 2023; San Antonio, Texas

An Investigational Oral Plasma Kallikrein Inhibitor for On-demand Treatment of Hereditary Angioedema: A Two-part, Randomized, Double-blind, Placebo-controlled, Crossover Phase 2 Trial

Emel Aygören-Pürsün, Andrea Zanichelli, Danny Cohn, Mauro Cancian, Roman Hakl, Tamar Kinaciyan, Markus Magerl, Inmaculada Martinez-Saguer, Marcin Stobiecki, Henriette Farkas, Sorena Kiani-Alikhan, Vesna Grivcheva-Panovska, Jonathan Bernstein, H Henry Li, Hilary Longhurst, Paul Audhya, Michael Smith, Christopher Yea, Andreas Maetzel, Daniel Lee, Edward Feener, Richard Gower, William Lumry, Aleena Banerji, Marc Riedl, Marcus Maurer

Lancet. 2023 Feb;401(10375):458-469

Efficacy of the Oral Plasma Kallikrein Inhibitor Sebetralstat (KVD900) by Attack Location in a Phase 2 Clinical Trial in Patients with Hereditary Angioedema

Emel Aygören-Pürsün, Andrea Zanichelli, Danny Cohn, Paul Audhya, Peter Williams, Christopher Yea, Michael Smith

Presented at the Western Society of Allergy, Asthma & Immunology (WSAAI) Annual Meeting; February 5-9, 2023; Kamuela, Hawaii

Pharmacokinetic, Pharmacodynamic, and Safety Profile in Healthy Japanese and White Adults: Results from Phase 1, Randomized, Double-blind, Placebo-controlled Trial

Matthew Iverson, Stanford Jhee, Erik Hansen, Edward Duckworth, Sally Hampton, Esther Yoon

Presented at the Western Society of Allergy, Asthma & Immunology (WSAAI) Annual Meeting; February 5-9, 2023; Kamuela, Hawaii

Sebetralstat (KVD900): A Potent and Selective Small Molecule Plasma Kallikrein Inhibitor Featuring a Novel P1 Group as a Potential On-demand Treatment for Hereditary Angioedema

Rebecca Davie, Hannah Edwards, D Michael Evans, Simon Hodgson, Stocks, Alun Smith, Louise Rushbrooke, Stephen Pethen, Michael Roe, David Clark, Paul McEwan, Sally Hampton

J Med Chem. 2022 Oct 27;65(20):13629-13644

Patient Perspectives on an Optimal Outcome Measure to Assess Efficacy in the Acute Treatment of Hereditary Angioedema Attacks

Marc Riedl, Danny Cohn, Emel Aygören-Pürsün, Andrea Zanichelli, Henriette Farkas, Jonathan Bernstein, William Lumry, Michael Smith, Christopher Yea, Paul Audhya

Presented at the 2022 HAEi Global Leadership Workshop; October 6-9, 2022; Frankfurt, Germany

Pharmacological Suppression of the Kallikrein Kinin System with KVD900: An Orally Available Plasma Kallikrein Inhibitor for the On-demand Treatment of Hereditary Angioedema

Edward Duckworth, Nivetha Murugesan, Lily Li, Louise Rushbrooke, Daniel Lee, Gian Marco De Donatis, Andreas Maetzel, Christopher Yea, Sally Hampton, Edward Feener

Clin Exp Allergy. 2022 Sep;52(9):1059-1070

Absorption, Metabolism and Excretion of Sebetralstat (KVD900) Following a Single Oral Dose in Healthy Male Participants

Peter Mutch, Mohammad Bashir, Bonnie Jung, Ping Yi, Matt Iverson

Xenobiotica. 2022 Jul;52(7):707-717

Population Pharmacokinetic Analysis of Sebetralstat (KVD900) in Healthy Volunteers and Patients with Hereditary Angioedema Predicts Similar Exposure in Adolescent Patients

Michael Smith, Trudy Rodgers, Johannah Sharman, Peter Mutch, Raffi Tachdjian, Sinisa Savic, Colm Farrell

Presented at European Academy of Allergy & Clinical Immunology (EAACI) Congress; July 1–3, 2022; Prague, Czech Republic

KVD900, An Oral On-demand Treatment for Hereditary Angioedema; Phase 1 Study Results

Andreas Maetzel, Michael Smith, Edward Duckworth, Sally Hampton, Gian Marco De Donatis, Nivetha Murugesan, Louise Rushbrooke, Lily Li, Danielle Francombe, Edward Feener, Christopher Yea

J Allergy Clin Immunol. 2022 Jun;149(6):2034-2042

Agreement Between Improvements in Patient Global Assessment of Change and Other Measures of Improvement and Attack Resolution Observed in a Phase 2 Trial with Sebetralstat (KVD900) in Patients with Hereditary Angioedema

Paul Audhya, Michael Smith, Peter Williams, Christopher Yea, Danny Cohn

Presented at the Eastern Allergy Conference (EAC); June 2-5, 2022; Palm Beach, Florida

Agreement of Patient Global Assessment of Change With Attack Resolution or Use of Rescue Medication in Patients with Hereditary Angioedema

Paul Audhya, Peter Williams, Christopher Yea, Danny Cohn

Presented at American Academy of Allergy, Asthma, and Immunology (AAAAI) Conference; February 25-28, 2022; Phoenix, Arizona

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