KalVista Pharmaceuticals Presents Phase 2 Clinical Data of Oral KVD900 for Treatment of HAE at C1-Inhibitor Deficiency & Angioedema Workshop
– KVD900 Efficacious Within First Hours of Attack and Significantly Shortens Time to Improvement of Attack Symptoms –
“Our goal is to provide the best outcome for HAE patients experiencing an attack, and that means offering them the ability to treat early in the attack progression to shorten attack duration,” said
Following is a brief summary of the presentation Fast improvement of hereditary angioedema (HAE) attacks with the oral on-demand plasma kallikrein inhibitor KVD900: an analysis of the pharmacokinetic and pharmacodynamic profile of KVD900 and attack symptom severity during a double-blind, randomized phase 2 cross-over trial in patients with HAE type I and II given by
- KVD900 achieves rapid plasma exposures, with near complete plasma kallikrein inhibition within 30 minutes.
- Attacks treated with KVD900 experienced a rapid improvement in the most severe baseline symptoms both in absolute terms and relative, when expressed as change from baseline. This improvement was maintained for 24 hours.
- KVD900 significantly accelerated improvement in attack severity as assessed using a composite Visual Analog Scale (VAS). A 50% reduction in the composite VAS was reached for 50% of the attacks treated with KVD900 within six hours versus greater than 12 hours for attacks treated with placebo. By 24 hours, 74% of KVD900-treated attacks showed a 50% reduction in score compared to 38% for placebo-treated attacks.
- Adverse events were of mild or moderate intensity with no severe or serious adverse events reported. Overall, the single administration of KVD900 appeared safe and well tolerated.
KVD900-201 was a double blind, placebo-controlled, crossover trial investigating the safety and efficacy of a single dose of 600 mg KVD900 as an on-demand treatment for HAE attacks in patients with Type 1 or Type 2 HAE. Following an open label phase, in which pharmacokinetic samples were collected over four hours, all patients progressed into the randomized phase of the trial. In this “at home” part of the trial, patients treated two attacks, one with 600 mg KVD900 and one with placebo in a randomized sequence. Patients administered treatment for each attack within one hour of attack onset, following confirmation with their physician, and then recorded symptoms and, if needed, the time to use of rescue (the patient’s conventional attack treatment). The time to rescue treatment within 12 hours was the primary outcome of the trial. Secondary outcomes included assessment of attack severity using categorical (PGI-S) and visual analogue scale (VAS) measures and the patient’s global impression of change (PGI-C).
The trial planned to complete at least 50 patients and enrolled 68 patients of which 53 completed the trial by treating two attacks. One patient withdrew consent and 14 patients were discontinued due to completion of the trial. No patients withdrew due to adverse events. The trial included 126 administrations of KVD900 and 55 of placebo. During the uncontrolled, open label phase, 5 of 68 patients dosed reported 8 adverse events suspected to be related to treatment. During the randomized, placebo-controlled phase, 5 patients reported adverse events suspected to be treatment-related (3 of 58 dosed with KVD900 and 2 of 55 dosed with placebo).
KVD900 has received Fast Track designation from the
The presentation will available on the Company’s website at www.kalvista.com.
For more information, please visit www.kalvista.com.
This press release contains "forward-looking" statements within the meaning of the safe harbor provisions of the
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