The U.S. Food and Drug Administration (FDA) has notified KalVista Pharmaceuticals, Inc. in a letter that it has placed a clinical hold on the proposed Phase 2 clinical trial of KVD824.
KVD824 is KalVista’s oral product candidate being developed for prophylactic treatment of HAE. An Investigational New Drug Application was submitted earlier in 2021 for a Phase 2 clinical trial to evaluate KVD824 as a potential prophylactic treatment for the prevention of HAE attacks. The FDA letter requests further information and analysis related to certain preclinical studies of KVD824 submitted to support the planned Phase 2 trial. Refinements were also proposed to the intended KVD824 Phase 2 study protocol. No new studies were requested nor was it suggested that new data be generated to initiate the Phase 2 trial.
“We intend to fully comply with the requests and recommendations provided by the FDA,” says Andrew Crockett, CEO of KalVista. “Although we no longer can confirm that the KVD824 Phase 2 trial will initiate this quarter, we are working to resolve their concerns in a timely fashion. Importantly, this letter relates solely to KVD824, and does not impact our activities or expectations with regard to KVD900, for which we continue to prepare for an End of Phase 2 FDA meeting and commencement of our Phase 3 efficacy trial.”
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. In both studies adverse event rates were similar in placebo and active arms, no subjects withdrew and no serious adverse events were reported.
KalVista will continue to work closely with the FDA on the overall development of KVD824 and will provide further updates as appropriate.