The U.S. Food and Drug Administration (FDA) has lifted the clinical hold on KalVista Pharmaceuticals, Inc.‘s Phase 2 clinical trial of KVD824 for oral prophylactic treatment of HAE.
“The execution of Komplete, our Phase 2 clinical trial for KVD824 as a potential oral prophylactic therapy for HAE, is expected to accelerate now that we can also proceed at our U.S. trial sites,” says Andrew Crockett, CEO of KalVista: “Progress continues worldwide, with regulatory submissions complete in all of the countries where the trial will be conducted.”
The previously announced clinical hold was removed after FDA review of KalVista’s responses to the FDA request for further information and analysis related to certain preclinical studies of KVD824. Refinements were also made to the KVD824 Phase 2 Komplete protocol. The company is working closely with study investigators and clinical trial sites to proceed with all study activities as soon as possible.
KalVista has previously reported data from first-in-human and formulation studies of KVD824 that were conducted in the UK. To date, a total of 121 subjects have received KVD824 as single doses up to 1280 mg and up to 14 days of twice-daily dosing of 600 mg and 900 mg. Data from the Phase 1 studies indicate that KVD824 maintains the plasma concentrations that we believe are required to deliver efficacy consistent with approved injectable therapies. In both studies adverse event rates were similar in placebo and active arms, no subjects withdrew, and no serious adverse events were reported.