Publications Archive - KalVista Pharmaceuticals

Global Frequency, Diagnosis, and Treatment of Hereditary Angioedema with Normal C1 Inhibitor

Markus Magerl, Marc Riedl, Luisa Karla Arruda, Andrea Bauer, Alejandro Berardi, Jonathan Bernstein, Laurence Bouillet, Matthew Buckland, Thomas Buttgereit, Danny Cohn, Timothy Craig, Roberta Criado, Aurélie Du-Thanh, Olivier Fain, Margarida Gonçalo, Jens Greve, Anete Sevciovic Grumach, Mar Guilarte, Constance Katelaris, Tamar Kinaciyan, Elena Latysheva, Ramon Lleonart, Oscar Calderón Llosa, Eli Mansour, Vesna Grivcheva-Panovska, Claudio Parisi, Nelson Augusto Rosario Filho, Amélia Spínola Santos, Petra Staubach, Anna Valerieva, Solange Oliveira Rodrigues Valle, Sherry Danese, Julie Ulloa, Paul Audhya, Marcus Maurer

J Allergy Cli Immunol Global. 2025 August; 4(3)100446. Online ahead of print.

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

Healthcare Utilization and Costs Among Hereditary Angioedema Patients Receiving Long-Term Prophylaxis: Results of a Claims Database Analysis

Raffi Tachdjian, Daniel Soteres, Maeve O'Connor, Chirag Maheshwari, Alice Wang, Paul Audhya, Timothy Craig

Presented at the Academy of Managed Care Pharmacy (AMCP) Annual Meeting, March 31 - April 3, 2025; Houston, Texas

Barriers to Timely On-Demand Treatment of Hereditary Angioedema Attacks in Italian Patients

Andrea Zanichelli, Paola Triggianese, 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, Massimo Triggiani, Sherry Danese, Julie Ulloa, Vibha Desai, Paul Audhya, Mauro Cancian

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

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

Indirect Treatment Comparison of Oral Sebetralstat and Intravenous Recombinant Human C1 Esterase Inhibitor for On-demand Treatment of Hereditary Angioedema Attacks

H. Henry Li, Emel Aygören-Pürsün, Markus Magerl, Timothy Craig, Michael Manning, Noemi Hummel, Agnieszka Kopiec, Shuai Fu, James Morris, Alice Wang, Paul Audhya, Jonathan Bernstein

Allergy Asthma Clin Immunol. 2025 Mar 15;21(1):10

Barriers to Timely On-Demand Treatment of Hereditary Angioedema Attacks in Italian Patients

Mauro Cancian, Paola Triggianese, 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, Massimo Triggiani, Sherry Danese, Julie Ulloa, Vibha Desai, Paul Audhya, Andrea Zanichelli

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

Burden of Injectable On-Demand Treatment for Hereditary Angioedema Attacks in Adolescents

Mauro Cancian, Paula Busse, Tariq El-Shanawany, Maeve O’Connor, Sinisa Savic, Paola Triggianese, Patrick Yong, Andrea Zanichelli, Sherry Danese, Julie Ulloa, Vibha Desai, Paul Audhya, Sandra Christiansen

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

Delays in the On-Demand Treatment of Hereditary Angioedema Attacks and Associated Barriers Reported in Different Healthcare Systems

Patrick Yong, Paula Busse, Timothy Craig, Tariq El-Shanawany, Padmalal Gurugama, Rashmi Jain, Maeve O’Connor, Cristine Radojicic, Sinisa Savic, H James Wedner, Sherry Danese, Julie Ulloa, Vibha Desai, Paul Audhya, Sandra Christiansen

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

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

Study to Adjudicate Hereditary Angioedema with Normal C1INH Diagnoses in the PIONEER-HAE Database

Maeve O’Connor, Dana Withrow, Scott Milligan, Vibha Desai, Paul Audhya, Marc Riedl

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

Impact of Long-Term Prophylaxis Adherence in Hereditary Angioedema Patients: Results of a Claims Database Analysis

Raffi Tachdjian, Daniel Soteres, Maeve O'Connor, Chirag Maheshwari, Alice Wang, Paul Audhya, Timothy Craig

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

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

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

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

Impact of Hereditary Angioedema Attacks on Quality of Life and Ability to Work Among UK Patients Receiving Long-term Prophylaxis or On-demand 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

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

On-demand Treatment of Hereditary Angioedema Attacks: Patient-reported Utilization, Barriers, and Outcomes

Sandra Christiansen, Maeve O’Connor, Timothy Craig, Cristine Radojicic, James Wedner, Sherry Danese, Julie Ulloa, Vibha Desai, Christopher Utter, Tomas Andriotti, Paul Audhya, Paula Busse

Ann Allergy Asthma Immunol. 2024 Dec 16:S1081-1206(24)01732-0. Online ahead of print.

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

Patient-Reported Anxiety Impacts Utilization of Injectable On-demand Treatment of Hereditary Angioedema Attacks

Cristine Radojicic, Autumn Burnette, Sally van Kooten, Neil Malloy, Markus Heckmann, Hilary Longhurst

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

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

Real World Barriers to On-Demand Treatment for Attacks in Hereditary Angioedema: A Patient Survey

Daisuke Honda, Sandra Christiansen, Julie Ulloa, Sherry Danese, Vibha Desai, Tomas Andriotti, Shigeru Yoshida, Paul Audhya, Michihiro Hide

Presented at the Japanese Society of Allergology Congress; October 18-20, 2024; Kyoto, Japan

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

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

Global Frequency and Diagnosis of Hereditary Angioedema with Normal C1INH: A Real World ACARE Survey

Markus Magerl, Marc Riedl, Sherry Danese, Julie Ulloa, Paul Audhya, Marcus Maurer

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

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

Delayed On-demand Treatment of Hereditary Angioedema Attacks: Italian Patient Perceptions and Associated Barriers

Stefania Nicola, Riccardo Senter, Pietro Accardo, Francesco Arcoleo, Donatella Bignardi, Caterina Colangelo, Francesco Giardino, Antonio Gidaro, Marica Giliberti, Maria Domenica Guarino, Paola Lucia Minciullo, Francesca Perego, Giuseppe Spadaro, Paola Triggianese, Massimo Triggiani, Sherry Danese, Julie Ulloa, Vibha Desai, Tomas Andriotti, Paul Audhya, Andrea Zanichelli, Mauro Cancian

Presented at the 2024 National Congress of the Italian Society of Allergy, Asthma and Clinical Immunology (SIAAIC); October 4-5, 2024; Rome, Italy

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

A Specific, Sensitivity Assay Measuring Patient Sample Plasma Kallikrein Activity

Daniel Lee, Arije Ghannam, Nivetha Murugesan, Denis Vincent, Adrian Mogg, Michael Smith, Sally Hampton, Edward Feener

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

Delayed On-demand Treatment of Hereditary Angioedema Attacks and Associated Barriers Reported by Italian Patients

Mauro Cancian, 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, Andrea Zanichelli

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

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

Closing Gaps in Hereditary Angioedema Management: Addressing Delays in On-demand Treatment

Douglas Jones

EMJ Allergy Immunol. 2024 Jul;9(1):37-43

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

The Complexities of Decision-Making Associated with On-Demand Treatment of Hereditary Angioedema (HAE) Attacks

Stephen Betschel, Teresa Caballero, Douglas Jones, Hilary Longhurst, Michael Manning, Sally van Kooten, Markus Heckmann, Sherry Danese, Ledia Goga, Autumn Burnette

Allergy Asthma Clin Immunol. 2024 Jul 25;20(1):43

Anxiety Associated with On-demand Treatment of Hereditary Angioedema (HAE) Attacks

Patrick Yong, Tariq El-Shanawany, Padmalal Gurugama, Rashmi Jain, Sherry Danese, Julie Ulloa, Vibha Desai, Paul Audhya, Sinisa Savic