KalVista Pharmaceuticals, Inc. (Nasdaq: KALV), a leader in developing small molecule therapies for diseases with significant unmet needs, announced new data from its KONFIDENT and KONFIDENT-S clinical studies evaluating EKTERLY® (sebetralstat), the first and only oral on-demand therapy for hereditary angioedema (HAE). The results, presented at the 20th German Allergy Congress (DGAKI) held from October 2–4, 2025, underscore EKTERLY’s ability to rapidly stop the progression of HAE attacks, deliver fast symptom relief, and remove key barriers associated with injectable on-demand therapies. The presentations also included insights from a recent German patient survey that highlights the pressing need for accessible and convenient oral treatments for HAE across Europe. Addressing a Critical Unmet Need in HAE Management Hereditary angioedema (HAE) is a rare, potentially life-threatening genetic disorder characterized by sudden and recurrent swelling in different parts of the body, including the extremities, face, abdomen, and airways. These attacks are often unpredictable and painful, and in severe cases, can cause airway obstruction requiring emergency intervention. For decades, patients have relied on injectable therapies for on-demand management of HAE attacks. However, challenges such as injection-site reactions, complex administration, and limited accessibility during acute episodes have discouraged many patients from treating early. These limitations often lead to delayed treatment and increased disease burden. EKTERLY® (sebetralstat), as the first oral plasma kallikrein inhibitor, represents a major therapeutic advance—offering the convenience of oral administration and rapid onset of action. The newly presented data reinforce EKTERLY’s potential to transform on-demand treatment and empower patients to take timely control of their symptoms. Key Findings from the KONFIDENT and KONFIDENT-S Studies Across multiple ePoster sessions at DGAKI, researchers presented comprehensive results demonstrating EKTERLY’s robust clinical performance and patient-reported outcomes. The data highlight the consistency of treatment effect observed in both the pivotal Phase 3 KONFIDENT trial and the ongoing KONFIDENT-S open-label extension study. 1. Rapid Control of HAE Attack Progression Data presented by Prof. Markus Magerl, MD, of Charité–Universitätsmedizin Berlin and the Fraunhofer Institute for Translational Medicine and Pharmacology (ITMP), showed that sebetralstat halted HAE attack progression in a median of 20 minutes across both clinical studies. “Halting an attack at its early stage is essential to reducing morbidity,” said Dr. Magerl. “The ability of sebetralstat to consistently stop attack progression within 20 minutes is a significant step forward in acute HAE care. Patients gain not only faster relief but also greater confidence to manage their condition independently.” This early control over attack progression translated into shorter attack duration, fewer severe episodes, and reduced need for rescue medication—key outcomes for improving patient quality of life. 2. Rapid Symptom Relief and Excellent Tolerability An interim analysis of the KONFIDENT-S trial, presented by Dr. Petra Staubach from the University Medical Center Mainz, provided further insights from 69 European participants who collectively treated 999 HAE attacks with sebetralstat. Key findings include: Median time to treatment: 16 minutes overall, and just 10 minutes in adolescents (ages 12–17) Median time to onset of symptom relief: 1.6 hours 35% of attacks were treated while still mild, indicating early intervention behavior Sebetralstat was well tolerated, with no new safety concerns identified These results underline the practicality of oral therapy—patients could initiate treatment almost immediately after attack onset, reducing the likelihood of severe progression and minimizing downtime from daily activities. Insights from German HAE Patient Survey: Barriers to Timely Care Complementing the clinical findings, Dr. Thomas Buttgereit of Charité–Universitätsmedizin Berlin presented data from a real-world survey assessing treatment behaviors and challenges among 49 German patients with HAE who had used approved on-demand therapies within the prior three months. The survey revealed striking barriers to timely care: Mean time to treatment: 3.9 hours after attack onset Only 18% of patients treated within the first hour Injection-site reactions were reported by 53% of participants 33% among those using intravenous therapies 94% among those using subcutaneous injections “These findings mirror what we observe in clinical practice,” said Dr. Buttgereit. “Too many patients delay treatment due to the discomfort and logistical challenges of injectable therapies. Such delays not only prolong attacks but also heighten the risk of severe complications. An oral on-demand treatment like sebetralstat has the potential to eliminate these barriers entirely, promoting earlier treatment and better outcomes.” KalVista’s Commitment to Innovation and Patient Access Dr. Paul Audhya, Chief Medical Officer of KalVista, emphasized the company’s mission to advance meaningful innovations that simplify disease management for patients worldwide. “The data presented at DGAKI underscore the transformative potential of EKTERLY for people living with HAE and the urgent need for accessible innovation across Europe,” said Dr. Audhya. “As we have seen in the U.S., many patients in Germany and other countries delay or avoid on-demand treatment due to the challenges associated with injections. An oral therapy like EKTERLY empowers patients to treat attacks earlier and more effectively.” With EKTERLY now approved in the European Union, KalVista is preparing for its initial launch in Germany during Q4 2025, followed by additional European market introductions throughout 2026 and beyond. Dr. Audhya added: “Our goal is to ensure that every person living with HAE, regardless of location, has access to safe, effective, and patient-friendly treatments. EKTERLY embodies that vision.” About EKTERLY® (Sebetralstat) EKTERLY (sebetralstat) is a selective oral plasma kallikrein inhibitor designed for on-demand treatment of hereditary angioedema attacks. By inhibiting kallikrein, the drug prevents excessive production of bradykinin—a key inflammatory mediator responsible for vascular leakage and swelling in HAE. Unlike injectable therapies that often require cold storage, training, and needle handling, EKTERLY offers a rapid, non-invasive, and patient-centered solution. The treatment can be self-administered at the first sign of symptoms, enabling faster control and potentially reducing healthcare utilization and emergency visits. About Hereditary Angioedema (HAE) Hereditary angioedema is a rare genetic disorder caused by deficiency or dysfunction of the C1 esterase inhibitor (C1-INH) protein, leading to uncontrolled activation of the kallikrein-kinin system. This cascade results in episodic swelling of the skin, gastrointestinal tract, or airway. Global prevalence: Approximately 1 in 50,000 people Symptoms: Recurrent swelling, pain, nausea, and potential airway obstruction Treatment goal: Rapidly manage attacks to prevent severe complications and improve quality of life Guidelines from leading allergy and immunology societies recommend treating all HAE attacks early, regardless of severity or anatomical location. EKTERLY’s oral formulation may enable faster and more widespread adherence to these guidelines. Looking Ahead: Redefining On-Demand HAE Care in Europe The cumulative evidence from the KONFIDENT program and real-world surveys positions EKTERLY as a first-in-class innovation capable of transforming on-demand HAE treatment in Europe. Its oral route of administration addresses long-standing challenges of injectable therapies—enhancing convenience, adherence, and patient satisfaction. As KalVista prepares for commercial rollout across Europe, the company’s focus will remain on collaboration with healthcare professionals, patient advocacy groups, and regulatory authorities to ensure broad and equitable access. The data presented at DGAKI mark a pivotal moment in the evolution of acute HAE management—shifting the paradigm from cumbersome injection-based treatment to swift, simple, and self-empowered oral care.

KalVista Pharmaceuticals, Inc., a leader in developing small molecule therapies for diseases with significant unmet needs, announced new data from its KONFIDENT and KONFIDENT-S clinical studies evaluating EKTERLY® (sebetralstat), the first and only oral on-demand therapy for hereditary angioedema (HAE). The results, presented at the 20th German Allergy Congress (DGAKI) held from October 2–4, 2025, underscore EKTERLY’s ability to rapidly stop the progression of HAE attacks, deliver fast symptom relief, and remove key barriers associated with injectable on-demand therapies.

The presentations also included insights from a recent German patient survey that highlights the pressing need for accessible and convenient oral treatments for HAE across Europe.

Addressing a Critical Unmet Need in HAE Management

Hereditary angioedema (HAE) is a rare, potentially life-threatening genetic disorder characterized by sudden and recurrent swelling in different parts of the body, including the extremities, face, abdomen, and airways. These attacks are often unpredictable and painful, and in severe cases, can cause airway obstruction requiring emergency intervention.

For decades, patients have relied on injectable therapies for on-demand management of HAE attacks. However, challenges such as injection-site reactions, complex administration, and limited accessibility during acute episodes have discouraged many patients from treating early. These limitations often lead to delayed treatment and increased disease burden.

EKTERLY® (sebetralstat), as the first oral plasma kallikrein inhibitor, represents a major therapeutic advance—offering the convenience of oral administration and rapid onset of action. The newly presented data reinforce EKTERLY’s potential to transform on-demand treatment and empower patients to take timely control of their symptoms.

Key Findings from the KONFIDENT and KONFIDENT-S Studies

Across multiple ePoster sessions at DGAKI, researchers presented comprehensive results demonstrating EKTERLY’s robust clinical performance and patient-reported outcomes. The data highlight the consistency of treatment effect observed in both the pivotal Phase 3 KONFIDENT trial and the ongoing KONFIDENT-S open-label extension study.

1. Rapid Control of HAE Attack Progression

Data presented by Prof. Markus Magerl, MD, of Charité–Universitätsmedizin Berlin and the Fraunhofer Institute for Translational Medicine and Pharmacology (ITMP), showed that sebetralstat halted HAE attack progression in a median of 20 minutes across both clinical studies.

“Halting an attack at its early stage is essential to reducing morbidity,” said Dr. Magerl. “The ability of sebetralstat to consistently stop attack progression within 20 minutes is a significant step forward in acute HAE care. Patients gain not only faster relief but also greater confidence to manage their condition independently.”

This early control over attack progression translated into shorter attack duration, fewer severe episodes, and reduced need for rescue medication—key outcomes for improving patient quality of life.

2. Rapid Symptom Relief and Excellent Tolerability

An interim analysis of the KONFIDENT-S trial, presented by Dr. Petra Staubach from the University Medical Center Mainz, provided further insights from 69 European participants who collectively treated 999 HAE attacks with sebetralstat.

Key findings include:

  • Median time to treatment: 16 minutes overall, and just 10 minutes in adolescents (ages 12–17)
  • Median time to onset of symptom relief: 1.6 hours
  • 35% of attacks were treated while still mild, indicating early intervention behavior
  • Sebetralstat was well tolerated, with no new safety concerns identified

These results underline the practicality of oral therapy—patients could initiate treatment almost immediately after attack onset, reducing the likelihood of severe progression and minimizing downtime from daily activities.

Insights from German HAE Patient Survey: Barriers to Timely Care

Complementing the clinical findings, Dr. Thomas Buttgereit of Charité–Universitätsmedizin Berlin presented data from a real-world survey assessing treatment behaviors and challenges among 49 German patients with HAE who had used approved on-demand therapies within the prior three months.

The survey revealed striking barriers to timely care:

  • Mean time to treatment: 3.9 hours after attack onset
  • Only 18% of patients treated within the first hour
  • Injection-site reactions were reported by 53% of participants
    • 33% among those using intravenous therapies
    • 94% among those using subcutaneous injections

“These findings mirror what we observe in clinical practice,” said Dr. Buttgereit. “Too many patients delay treatment due to the discomfort and logistical challenges of injectable therapies. Such delays not only prolong attacks but also heighten the risk of severe complications. An oral on-demand treatment like sebetralstat has the potential to eliminate these barriers entirely, promoting earlier treatment and better outcomes.”

KalVista’s Commitment to Innovation and Patient Access

Dr. Paul Audhya, Chief Medical Officer of KalVista, emphasized the company’s mission to advance meaningful innovations that simplify disease management for patients worldwide.

“The data presented at DGAKI underscore the transformative potential of EKTERLY for people living with HAE and the urgent need for accessible innovation across Europe,” said Dr. Audhya. “As we have seen in the U.S., many patients in Germany and other countries delay or avoid on-demand treatment due to the challenges associated with injections. An oral therapy like EKTERLY empowers patients to treat attacks earlier and more effectively.”

With EKTERLY now approved in the European Union, KalVista is preparing for its initial launch in Germany during Q4 2025, followed by additional European market introductions throughout 2026 and beyond.

Dr. Audhya added:

“Our goal is to ensure that every person living with HAE, regardless of location, has access to safe, effective, and patient-friendly treatments. EKTERLY embodies that vision.”

About EKTERLY® (Sebetralstat)

EKTERLY (sebetralstat) is a selective oral plasma kallikrein inhibitor designed for on-demand treatment of hereditary angioedema attacks. By inhibiting kallikrein, the drug prevents excessive production of bradykinin—a key inflammatory mediator responsible for vascular leakage and swelling in HAE.

Unlike injectable therapies that often require cold storage, training, and needle handling, EKTERLY offers a rapid, non-invasive, and patient-centered solution. The treatment can be self-administered at the first sign of symptoms, enabling faster control and potentially reducing healthcare utilization and emergency visits.

About Hereditary Angioedema (HAE)

Hereditary angioedema is a rare genetic disorder caused by deficiency or dysfunction of the C1 esterase inhibitor (C1-INH) protein, leading to uncontrolled activation of the kallikrein-kinin system. This cascade results in episodic swelling of the skin, gastrointestinal tract, or airway.

  • Global prevalence: Approximately 1 in 50,000 people
  • Symptoms: Recurrent swelling, pain, nausea, and potential airway obstruction
  • Treatment goal: Rapidly manage attacks to prevent severe complications and improve quality of life

Guidelines from leading allergy and immunology societies recommend treating all HAE attacks early, regardless of severity or anatomical location. EKTERLY’s oral formulation may enable faster and more widespread adherence to these guidelines.

Looking Ahead: Redefining On-Demand HAE Care in Europe

The cumulative evidence from the KONFIDENT program and real-world surveys positions EKTERLY as a first-in-class innovation capable of transforming on-demand HAE treatment in Europe. Its oral route of administration addresses long-standing challenges of injectable therapies—enhancing convenience, adherence, and patient satisfaction.

As KalVista prepares for commercial rollout across Europe, the company’s focus will remain on collaboration with healthcare professionals, patient advocacy groups, and regulatory authorities to ensure broad and equitable access.

The data presented at DGAKI mark a pivotal moment in the evolution of acute HAE management—shifting the paradigm from cumbersome injection-based treatment to swift, simple, and self-empowered oral care.

About EKTERLY® (sebetralstat)

EKTERLY (sebetralstat) is a novel plasma kallikrein inhibitor approved in the United States, European Union, United Kingdom and Switzerland for the treatment of acute attacks of hereditary angioedema (HAE) in people 12 years of age and older. EKTERLY is the first and only oral on-demand treatment for HAE, offering efficacious and safe treatment of attacks without the burden of injections. With ongoing studies exploring its use in children aged two to 11 and multiple regulatory applications under review in key global markets, EKTERLY has the potential to become the foundational therapy for HAE management worldwide. For more information, including the full U.S. Prescribing Information, visit EKTERLY.com.

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