Press release
KalVista Pharmaceuticals Presents New Sebetralstat Data at the 2024 American College of Allergy Asthma and Immunology
–Phase 3 trial data show that early treatment is correlated with shorter attack duration– – Rigorous comparison of Phase 3 results for oral sebetralstat and
About this update from Kalvista Pharmaceuticals, Inc.
[{"type":"text","content":"\n–Phase 3 trial data show that early treatment is correlated with shorter attack duration–\n\n– 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 –\n\n CAMBRIDGE, Mass. & SALISBURY, England--(BUSINESS WIRE)--\nKalVista 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.\n\nTim 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).\n\n“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.”\n\nWilliam 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.\n\n“All other clinical trial designs for on-demand therapy have required attacks to be at least moderate in severity to be eligible to ...