Scientific presentations highlight real-world patient experience, treatment satisfaction and quality-of-life outcomes with sebetralstat

The addition of sebetralstat to Chiesi’s rare immunology portfolio strengthens its long-term commitment to people living with rare conditions and their families

Company Website: https://www.kalvista.com/
FRAMINGHAM, Mass. -- (Business Wire)

KalVista Pharmaceuticals, Inc. (“KalVista”), a company of the Chiesi Group, today announced the presentation of new clinical and real-world research evaluating sebetralstat at the American College of Allergy, Asthma & Immunology (ACAAI) 2026 Annual Scientific Meeting in Phoenix (November 12-16). The five presentations highlight patient-reported satisfaction with sebetralstat, reasons for treatment switching, long-term health-related quality-of-life (QoL) outcomes, healthcare resource utilization among adolescents and clinician-reported caregiver burden. Together, these findings underscore the value of integrating real-world evidence and patient-reported outcomes to better evaluate the patient experience alongside treatment impact beyond conventional clinical trial endpoints. The research also reflects KalVista’s continued commitment to advancing hereditary angioedema (HAE) care, now as part of Chiesi Global Rare Diseases, with opportunities to build on broader rare disease capabilities and global reach.

“With our acquisition of KalVista Pharmaceuticals, the addition of sebetralstat to our rare immunology portfolio marks a major milestone in Chiesi’s longstanding commitment to rare disease communities,” said Giacomo Chiesi, Executive Vice President, Chiesi Global Rare Diseases. “As we build on KalVista’s deep expertise in HAE, close collaboration with the scientific and patient communities will remain essential to deepening our understanding of lived experiences and advancing care for people living with rare diseases today and for generations to come.”

The five presentations at ACAAI add to the growing body of clinical and real-world evidence evaluating sebetralstat, building on recent findings presented at the 2026 HAEi Regional Conference Americas and Bradykinin Symposium 2026. Together, these data provide further insights into clinical practice and patient-reported experiences, while reflecting continued progress in understanding the use of sebetralstat across the HAE community, including pediatric patients.

“Real-world evidence and patient-reported outcomes provide important insights into clinical practice and the everyday realities of managing HAE,” said William R. Lumry, MD, Clinical Professor of Internal Medicine at the University of Texas Southwestern Medical School and Medical Director of AARA Research Center, Dallas, Texas. ”Understanding patient satisfaction, treatment preferences and quality-of-life factors helps us better evaluate the full impact of disease management. As clinicians, we are encouraged by the ongoing research that expands our understanding of HAE across both adult and pediatric populations as it can help inform care and potentially expand treatment options.”

“The presentations at ACAAI reflect a research approach that looks beyond efficacy to the full treatment experience, including the emotional and practical factors that influence when and how people manage their attacks,” said Rachele Berria, MD, PhD, Senior Vice President, Medical Affairs, Chiesi Group. “The real-world evidence and quality-of-life data offer valuable perspective on the lived experiences of people with HAE and the considerations healthcare professionals need to take into account when making treatment decisions. These insights are increasingly important as we work to align treatment strategies with patient preferences and advance our clinical research across age groups.”

Beyond the data presented at these congresses, KalVista, now a company of the Chiesi Group, remains focused on advancing HAE care through continued research and collaboration with the scientific, clinical and patient communities. Together, KalVista and Chiesi are committed to building on this progress to help address the evolving needs of people living with HAE worldwide.

Details of presentations are as follows:

American College of Allergy, Asthma & Immunology (ACAAI) 2026 Annual Scientific Meeting

Abstract Title: Satisfaction with Sebetralstat for On-Demand Treatment of HAE Attacks: Real-World Data from the EARLY Study
Format: ePoster with Meet the Author presentations. All ePosters will be displayed and published online for viewing by meeting attendees using the ePosters Live System.
Presenter: Joshua S. Jacobs, MD, Medical Director of Allergy and Asthma Clinical Research, Inc., Walnut Creek, California.
Date/Time: Friday, November 13, 3:20 pm - 3:35 pm MT

• EARLY is an ongoing phase 4, prospective, real-world, observational study evaluating the effectiveness of sebetralstat in adolescents and adults with HAE. This presentation will highlight patient satisfaction data from completed HAE attack eDiaries that were prospectively collected (January-June 2026) from US participants aged ≥12 y who had been prescribed or were taking sebetralstat for 3 months before enrollment.

Abstract Title: Reasons for Switching to Oral Sebetralstat for HAE Attacks: Real-World Data from the EARLY Study
Format: ePoster with Meet the Author presentations. All ePosters will be displayed and published online for viewing by meeting attendees using the ePosters Live System.
Presenter: William R. Lumry, MD,Clinical Professor of Internal Medicine at the University of Texas Southwestern Medical School and Medical Director of AARA Research Center, Dallas, Texas.
Date/Time: Friday, November 13, 5:05 pm - 5:20 pm MT

• EARLY is an ongoing phase 4, prospective, real-world, observational study evaluating the effectiveness of sebetralstat in adolescents and adults with HAE. This presentation will highlight baseline data on reasons for switching to sebetralstat, collected from 56 US participants ≥12 y who had been prescribed or were taking sebetralstat for on-demand treatment of HAE attacks for 3 months before enrollment.

Abstract Title: Treatment and Healthcare Resource Utilization in Adolescent Patients with Hereditary Angioedema: US Claims Database Analysis
Format: ePoster with Meet the Author presentations. All ePosters will be displayed and published online for viewing by meeting attendees using the ePosters Live System.
Presenter: Adil Adatia, MD, Assistant Professor in the Department of Medicine at the University of Alberta, Edmonton, Alberta, Canada.
Date/Time: Friday, November 13, 5:35 pm - 5:50 pm MT

• This study characterized real-world use of on-demand treatments and healthcare resource utilization among adolescent patients aged 12 to 17 years old living with HAE. This presentation will highlight data collected from the IQVIA PharMetrics® Plus Closed Health Plan Claims Database (study period: January 1, 2021 – December 31, 2024) to evaluate patterns that may help inform strategies to optimize disease management and reduce healthcare burden.

Abstract Title: Improvement in Health-related Quality of Life with Sebetralstat for HAE Attacks in Adolescents and Adults
Format: ePoster with Meet the Author presentations. All ePosters will be displayed and published online for viewing by meeting attendees using the ePosters Live System.
Presenter: Jonathan A. Bernstein, MD, Professor of Medicine, University of Cincinnati College of Medicine and Investigator at Bernstein Clinical Research Center, Cincinnati, Ohio.
Date/Time: Saturday, November 14, 11:45 am - 12:00 pm MT

• KONFIDENT-S is a 2-year open-label extension study, in which participants completed the angioedema quality of life (AE-QoL) questionnaire at the Enrollment Visit (baseline) and in the eDiary every 28 (± 7) days thereafter. This presentation will highlight data on health-related quality of life (QoL) from adolescent and adult participants who treated attacks with sebetralstat.

Abstract Title: Impact of Injectable HAE On-demand Treatments on Children and Caregivers: a Clinician Interview Study
Format: ePoster with Meet the Author presentations. All ePosters will be displayed and published online for viewing by meeting attendees using the ePosters Live System.
Presenter: Timothy J. Craig, DO, Professor, Department of Medicine, The Pennsylvania State University, Hershey, Pennsylvania.
Date/Time: Sunday, November 15, 12:15 pm - 12:30 pm MT

• This presentation will highlight findings of targeted literature review and interviews with clinical experts in HAE to understand the impact of HAE and the burden of injectable on-demand treatment on children aged ≤11 years and their caregivers.

About EKTERLY^® (sebetralstat)
EKTERLY (sebetralstat) is a novel plasma kallikrein inhibitor approved in the United States, European Union, United Kingdom, Switzerland, Australia, Singapore and Japan for the treatment of acute attacks of hereditary angioedema (HAE) in people 12 years of age and older. For more information, including the full US Prescribing Information, visit EKTERLY.com.

INDICATION
EKTERLY^® (sebetralstat) is a plasma kallikrein inhibitor indicated for the treatment of acute attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 12 years and older.

IMPORTANT SAFETY INFORMATION
Adverse reactions: The most commonly reported adverse reaction was headache (3.2%).

Drug interactions: EKTERLY is a substrate of CYP3A4. Concomitant use of EKTERLY with a strong CYP3A4 inhibitor increases sebetralstat exposure, which may increase the risk of sebetralstat adverse reactions. Avoid use of EKTERLY with strong CYP3A4 inhibitors and reduce the dose of EKTERLY to one dose of 300 mg (one tablet) with moderate CYP3A4 inhibitors. Concomitant use of EKTERLY with a strong or moderate CYP3A4 inducer decreases sebetralstat exposure, which may decrease efficacy. The use of EKTERLY with strong or moderate CYP3A4 inducers is not recommended.

Use in specific populations: Avoid use of EKTERLY in patients with severe hepatic impairment (Child-Pugh Class C). The recommended dosage of EKTERLY is one dose of 300 mg (one tablet) in patients with moderate hepatic impairment (Child-Pugh Class B). There are no available data on EKTERLY in pregnant women to evaluate for a drug associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes.

There are no data on the presence of sebetralstat or its metabolite in human milk, the effects on the breastfed infant, or the effects on milk production.

The safety and effectiveness of EKTERLY in pediatric patients aged under 12 years of age have not been established.

To report SUSPECTED ADVERSE REACTIONS, contact KalVista Pharmaceuticals, Inc. at 1-855-258-4782 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see the fullPrescribing Information.

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. Treatment guidelines recommend treating attacks as early as possible to prevent progression of swelling and shorten the time to attack resolution, and to consider treatment for all attacks, regardless of anatomic location or severity.

About KalVista Pharmaceuticals, Inc.
KalVista, a company of the Chiesi Group, is a global pharmaceutical company dedicated to delivering oral therapies for people affected by rare diseases with significant unmet needs. The KalVista team discovered and developed sebetralstat for hereditary angioedema (HAE) and continues to work closely with the global HAE community to improve treatment and care worldwide. As part of Chiesi Global Rare Diseases, a Chiesi Group business unit established to deliver innovative therapies and solutions for people living with rare diseases, KalVista is building on its expertise in HAE and contributing to a shared mission to help underserved rare disease communities live their most fulfilling lives.

For more information, please visit www.kalvista.com and www.chiesirarediseases.com.

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Contacts:

Media Contact
Chiara Travagin, Head of Global Communications, Rare Diseases
c.travagin@chiesi.com
Tel: +39 348.8818985

Source: KalVista Pharmaceuticals, Inc.