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KalVista Pharmaceuticals Presents New Sebetralstat Data at the 2024 American College of Allergy Asthma and Immunology

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KalVista Pharmaceuticals (NASDAQ: KALV) presented new data for sebetralstat at the 2024 American College of Allergy Asthma and Immunology. Phase 3 trial results showed that early treatment leads to faster attack resolution in hereditary angioedema (HAE) patients. The data demonstrated that sebetralstat 300mg and 600mg achieved faster reduction in symptom burden compared to placebo, with median times of 5.0 and 5.2 hours versus >12 hours. A network meta-analysis found no significant differences between sebetralstat 300mg and IV recombinant C1-inhibitor in time to symptom relief. For laryngeal attacks, sebetralstat 600mg showed median time to symptom relief of 1.5 hours.

KalVista Pharmaceuticals (NASDAQ: KALV) ha presentato nuovi dati per sebetralstat al Congresso Americano di Allergia, Asma e Immunologia del 2024. I risultati del trial di fase 3 hanno mostrato che un trattamento precoce porta a una risoluzione più rapida degli attacchi nei pazienti con angioedema ereditario (HAE). I dati hanno dimostrato che sebetralstat 300mg e 600mg hanno ottenuto una riduzione più rapida del carico sintomatico rispetto al placebo, con tempi medi di 5,0 e 5,2 ore contro più di 12 ore. Un'analisi meta-rete non ha trovato differenze significative tra sebetralstat 300mg e un inibitore di C1 ricombinante IV nel tempo per il sollievo dai sintomi. Per gli attacchi laringei, sebetralstat 600mg ha mostrato un tempo medio per il sollievo dei sintomi di 1,5 ore.

KalVista Pharmaceuticals (NASDAQ: KALV) presentó nuevos datos sobre sebetralstat en el Congreso Americano de Alergia, Asma e Inmunología de 2024. Los resultados del ensayo de fase 3 mostraron que un tratamiento temprano conduce a una resolución más rápida de los ataques en pacientes con angioedema hereditario (HAE). Los datos demostraron que sebetralstat 300mg y 600mg lograron una reducción más rápida en la carga de síntomas en comparación con el placebo, con tiempos medianos de 5,0 y 5,2 horas frente a más de 12 horas. Un meta-análisis de red no encontró diferencias significativas entre sebetralstat 300mg y un inhibidor de C1 recombinante IV en el tiempo para el alivio de los síntomas. Para los ataques laríngeos, sebetralstat 600mg mostró un tiempo medio para el alivio de los síntomas de 1,5 horas.

칼비스타 제약 (NASDAQ: KALV)는 2024년 미국 알레르기, 천식 및 면역학회에서 세베트랄스타트에 대한 새로운 데이터를 발표했습니다. 3상 시험 결과는 조기 치료가 유전성 혈관 부종(HAE) 환자에서 공격 해소를 더 빠르게 하는 것으로 나타났습니다. 데이터에 따르면 세베트랄스타트 300mg과 600mg은 위약에 비해 증상 부담을 더 빠르게 줄였으며, 중간 시간은 각각 5.0시간과 5.2시간으로 12시간 이상과 비교되었습니다. 네트워크 메타 분석에서는 세베트랄스타트 300mg과 IV 재조합 C1 억제제 간의 증상 완화 시간에 유의미한 차이가 없음을 발견했습니다. 후두 공격의 경우, 세베트랄스타트 600mg은 증상 완화까지의 중간 시간이 1.5시간으로 나타났습니다.

KalVista Pharmaceuticals (NASDAQ: KALV) a présenté de nouvelles données sur le sebetralstat lors du Congrès Américain d'Allergie, d'Asthme et d'Immunologie de 2024. Les résultats de l'essai de phase 3 ont montré qu'un traitement précoce conduit à une résolution plus rapide des crises chez les patients atteints d'angiœdème héréditaire (HAE). Les données ont démontré que le sebetralstat 300 mg et 600 mg ont atteint une réduction plus rapide de la charge symptomatique par rapport au placebo, avec des temps médian de 5,0 et 5,2 heures contre plus de 12 heures. Une méta-analyse en réseau n'a trouvé aucune différence significative entre le sebetralstat 300 mg et l'inhibiteur de C1 recombinant IV concernant le temps jusqu'au soulagement des symptômes. Pour les attaques laryngées, le sebetralstat 600 mg a montré un temps médian de soulagement des symptômes de 1,5 heure.

KalVista Pharmaceuticals (NASDAQ: KALV) hat auf dem Amerikanischen Kongress für Allergie, Asthma und Immunologie 2024 neue Daten zu Sebetralstat präsentiert. Die Ergebnisse der Phase-3-Studie zeigen, dass eine frühe Behandlung zu einer schnelleren Auflösung von Anfällen bei Patienten mit hereditärem Angioödem (HAE) führt. Die Daten zeigten, dass Sebetralstat 300mg und 600mg eine schnellere Reduktion der Symptombelastung im Vergleich zu Placebo erreichten, mit Medianzeiten von 5,0 und 5,2 Stunden im Gegensatz zu >12 Stunden. Eine Netzwerk-Metaanalyse fand keine signifikanten Unterschiede zwischen Sebetralstat 300mg und IV rekombinantem C1-Inhibitor in der Zeit bis zur Symptommilderung. Bei laryngealen Anfällen zeigte Sebetralstat 600mg eine mittlere Zeit bis zur Symptommilderung von 1,5 Stunden.

Positive
  • Phase 3 trial showed faster attack resolution with early treatment
  • Sebetralstat (both 300mg and 600mg) achieved significantly faster symptom reduction vs placebo (5.0-5.2 hours vs >12 hours)
  • Comparable efficacy to injectable treatments based on meta-analysis
  • Fast median time to symptom relief (1.5 hours) in laryngeal attacks
Negative
  • None.

Insights

The Phase 3 trial data for sebetralstat demonstrates significant clinical potential in treating Hereditary Angioedema (HAE) attacks. Key findings show that early treatment correlates with faster attack resolution, with attacks treated in the first quartile resolving more quickly than those treated later. The drug achieves median symptom relief in 5 hours for moderate severity attacks versus >12 hours for placebo.

Particularly noteworthy is the data on laryngeal attacks, where sebetralstat showed a median time to symptom relief of 1.5 hours when administered within 8 minutes of attack onset. The comparison with intravenous rhC1-INH shows comparable efficacy, suggesting sebetralstat could offer similar benefits to injectable treatments but with reduced treatment barriers.

This oral treatment option could address a significant unmet need, as current survey data indicates patients wait an average of 2.4 hours before using injectable treatments, often due to anxiety about injection.

–Phase 3 trial data show that early treatment is correlated with shorter attack duration–

– Rigorous comparison of Phase 3 results for oral sebetralstat and pivotal trial results of IV recombinant C1-inhibitor for on-demand treatment of HAE attacks shows no differences in time to beginning of symptom relief –

CAMBRIDGE, Mass. & SALISBURY, England--(BUSINESS WIRE)-- KalVista Pharmaceuticals, Inc. (NASDAQ: KALV), today announced the presentation of new sebetralstat data at the American College of Allergy Asthma and Immunology (ACAAI) taking place in Boston, MA from October 24 - 28, 2024.

Tim Craig, DO, Professor, Departments of Medicine and Pediatrics, Division of Pulmonary, Allergy and Critical Care Medicine, Penn State Health, and KONFIDENT investigator, presented data on the Correlation of Time to Treatment with Attack Duration in the Sebetralstat KONFIDENT Phase 3 Trial that showed complete attack resolution was achieved faster in attacks that were treated earlier (1st quartile) compared with those treated later (4th quartile).

“This is the first time in a Phase 3 on-demand trial where we can see that treating attacks within minutes versus hours has a meaningful impact on clinical outcomes. While injectable on-demand therapies are effective, there are numerous barriers patients face that lead to delay or denial of HAE on-demand treatment,” said Dr. Craig. “These data help to clarify the potential value of sebetralstat if approved: reduced burden enabling patients to treat attacks early and achieve earlier symptom relief and shorter attack duration.”

William Lumry, MD, Medical Director AARA Research Center, Dallas and KONFIDENT investigator, presented data on the Substantial Reduction of HAE Symptom Burden in the Sebetralstat Phase 3 KONFIDENT Trial which showed that among attacks that had progressed to at least moderate severity on the Patient Global Impression of Severity (PGI-S) prior to treatment, those treated with sebetralstat 300mg (n=49, P=0.002) and sebetralstat 600mg (n=52, P=0.034) achieved a faster reduction in substantial symptom burden (reduction in PGI-S to “mild”) than with placebo (n=46), with median times of 5.0 hours, 5.2 hours, and >12 hours, respectively.

“All other clinical trial designs for on-demand therapy have required attacks to be at least moderate in severity to be eligible to treat. This changed with the sebetralstat Phase 2 and 3 trials which, consistent with modern HAE guidelines, instructed patients to treat attacks early. Despite this, approximately half of attacks progressed in severity prior to treatment,” said Dr. Lumry. “Among these more severe attacks, which were treated somewhat later, sebetralstat reduced symptom burden to “mild” significantly faster than placebo, with a median time of approximately 5 hours for sebetralstat vs >12 hours for placebo.”

The following are details for the additional ePoster - Meet the Author data presentations at ACAAI 2024:

  • Indirect Treatment Comparison of Oral Sebetralstat and Intravenous rhC1-INH as On demand Treatments for Hereditary Angioedema: H. Henry Li, Institute for Asthma and Allergy, Chevy Chase, MD, USA
    • The network meta-analysis (NMA) fixed effects model found no significant differences in time to beginning of symptom relief between sebetralstat 300mg and IV-rhC1-INH 50 IU/kg (HR [95% CI] 0.96 [0.42-2.15] to 1.19 [0.58-2.45]).
    • After adjusting for baseline attack severity, matching-adjusted indirect comparison showed numerically favorable results with sebetralstat versus IV-rhC1-INH.
  • On-demand Treatment of Laryngeal Hereditary Angioedema Attacks with Sebetralstat: Pooled Analysis from KONFIDENT and KONFIDENT-S: Emel Aygören-Pürsün, University Hospital Frankfurt, Goethe University Frankfurt, Frankfurt, Germany
    • Pooled Analysis from KONFIDENT and KONFIDENT-S included 16 laryngeal attacks treated with sebetralstat 600mg. Median time to treatment was 8 minutes.
    • Median time to beginning of symptom relief was 1.5 hours; median time to reduction in severity was 1.7 hours; median time to complete attack resolution was 9.7 hours.
  • Patient-Reported Anxiety Impacts Utilization of Injectable On-demand Treatment of Hereditary Angioedema Attacks: Cristine Radojicic, Duke University School of Medicine, Durham, NC, USA
    • The survey highlighted patients with Type I/II HAE who reported waiting 2.4 hours to treat their HAE attack after recognizing the initial onset of the attack.
    • Those who were experiencing anxiety related to their injectable on-demand treatment were most likely to delay or not treat attacks.

“The HAE community has long sought a less invasive treatment option that combines needed efficacy with lower treatment burden. These presentations continue to demonstrate that sebetralstat has the potential to provide injectable-like efficacy in a pill,” said Ben Palleiko, CEO of KalVista Pharmaceuticals. “If approved, sebetralstat will be the only on-demand treatment option that will have demonstrated the ability to enable compliance with treatment guidelines that call for early treatment of attacks, regardless of severity or location.”

Links to all posters and presentations can be found on the KalVista website under Publications.

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 whose mission is to develop and deliver life-changing oral medicines for people affected by rare diseases with significant unmet need. Sebetralstat, our novel, investigational candidate for the oral, on-demand treatment of hereditary angioedema, is under regulatory review by the U.S. FDA with a PDUFA goal date of June 17, 2025. In addition, we have completed marketing authorization application (MAA) submissions for sebetralstat to the European Medicines Agency as well as the United Kingdom, Switzerland, Australia, and Singapore, and we anticipate filing a MAA in Japan in late 2024. For more information, 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.

Jenn Snyder

Vice President, Corporate Affairs

(617) 448-0281

jsnyder@kalvista.com

Ryan Baker

Head, Investor Relations

(617) 771-5001

ryan.baker@kalvista.com

Source: KalVista Pharmaceuticals, Inc.

FAQ

What were the key findings of KalVista's (KALV) sebetralstat Phase 3 trial presented at ACAAI 2024?

The Phase 3 trial showed that early treatment with sebetralstat led to faster attack resolution, with both 300mg and 600mg doses achieving symptom reduction to 'mild' in approximately 5 hours compared to >12 hours for placebo.

How does sebetralstat (KALV) compare to injectable HAE treatments in efficacy?

According to the network meta-analysis presented at ACAAI 2024, there were no significant differences in time to symptom relief between sebetralstat 300mg and IV recombinant C1-inhibitor treatments.

What are the results of sebetralstat (KALV) in treating laryngeal HAE attacks?

In the pooled analysis from KONFIDENT and KONFIDENT-S trials, sebetralstat 600mg showed a median time to symptom relief of 1.5 hours and complete attack resolution of 9.7 hours in laryngeal attacks.

KalVista Pharmaceuticals, Inc.

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