KalVista Pharmaceuticals, Inc. provides an update on clinical trial progress for KVD824 in development for oral prophylactic treatment of HAE.
“Over the past month we have made substantial progress in commencing Komplete, our worldwide Phase 2 clinical trial of KVD824 as a potential oral prophylactic therapy for HAE,” says Andrew Crockett, CEO of KalVista. “The regulatory submissions have been approved in Canada, Australia, and the UK, with patient enrollment expected to begin this quarter. We also submitted our clinical hold response to the FDA related to the US IND filing for KVD824 and will provide further updates once we have additional information.”
Komplete is the Phase 2 clinical trial of KVD824, and is a randomized, double-blind, parallel group design evaluating twice-daily dosing of 300 mg, 600 mg, and 900 mg KVD824 against placebo for 12 weeks. The trial will enroll 48 HAE patients randomized into four equal arms after they report experiencing a minimum of three attacks in an eight-week run-in period. The primary endpoint of the trial is the rate of investigator confirmed HAE attacks during the treatment period. Secondary endpoints include the proportion of participants without investigator confirmed HAE attacks and the rate of investigator confirmed HAE attacks that require conventional treatment. Komplete will be conducted at more than 30 sites in 13 countries.
To date, a total of 121 subjects have been exposed to treatment with KVD824 as single doses up to 1280 mg and up to 14 days of twice-daily dosing of 600 mg and 900 mg. The formulation of KVD824 maintains the plasma concentrations that we believe are required to deliver efficacy consistent with approved injectable therapies. Twice-daily dosing of KVD824 up to 14 days has demonstrated an encouraging safety and tolerability profile.(Source: KalVista)