LL schreef op 9 november 2021 13:10:
KalVista Pharmaceuticals Presents Data Demonstrating KVD900 Achieves Rapid Exposure and Improves Outcomes as Oral On-Demand Treatment of HAENovember 8, 2021 at 6:30 AM EST
– KVD900 Phase 2 data presented at American College of Allergy, Asthma & Immunology Annual Scientific Meeting –
CAMBRIDGE, Mass. & SALISBURY, England--(BUSINESS WIRE)--Nov. 8, 2021-- KalVista Pharmaceuticals, Inc. (NASDAQ: KALV), a clinical stage pharmaceutical company focused on the discovery, development, and commercialization of small molecule protease inhibitors, today announced data presented at American College of Allergy, Asthma & Immunology (ACAAI) Annual Scientific Meeting. Data presentations included an oral presentation and poster presentation on Phase 2 data for KVD900, KalVista’s lead program for oral on-demand treatment of hereditary angioedema (HAE) attacks.
“Current guidelines recommend effective on-demand therapy for every patient with HAE to reduce symptom severity and attack duration,” said Jonathan Bernstein, FAAAAI, FACAAI, FACP, M.D., University of Cincinnati College of Medicine and Bernstein Clinical Research Center, LLC. “Treatment of HAE attacks with KVD900 achieved rapid plasma exposure which was associated with faster improvements in initial symptom relief compared with placebo. As the first oral on-demand treatment to demonstrate this early therapeutic effect for patients, KVD900 may represent a remarkable advancement for management of the disease.”
Oral Presentation: On-Demand Oral Treatment with KVD900 for HAE Attacks Achieves Rapid Exposures and Improves Patient Outcomes
KVD900 was rapidly absorbed, with measurable concentrations detected within 15 minutes
Plasma levels reached peak concentration within 1 hour of administration
Median time to symptom improvement was significantly shorter with KVD900 than with placebo (1.6 vs 9.0 hours, p<0.0001), as indicated by the Patient Global Impression of Change (PGI-C) scale
A significantly higher percentage of patients also rated their HAE attack symptoms as improved within 12 and 24 hours with KVD900 compared with placebo
Poster Title: Relationship Between PGI-C Scale and Other Patient Reported Outcomes (PROs) in KVD900 Trial in HAE
In a Phase 2 trial, several PROs were collected to capture the patient experience
60 patients completed treatment for at least one attack (n=113 attacks). PGI-C scoring of “a little better” or higher at two consecutive timepoints had 97% sensitivity for composite visual analogue scale (VAS) and Patient Global Impression of Severity (PGI-S) improvement.
Moderate to substantial agreement between PGI-C and the other measures suggests that improvement on PGI-C was clinically significant from the patients’ perspective.
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