KalVista Pharma terminates KOMPLETE phase II clinical trial for KVD 824 for the prevention of attacks in people with hereditary angioedema

This decision was based on the observation of liver enzyme (ALT/AST) elevations in multiple patients in all treatment groups of the trial. No patients had concomitant elevation of bilirubin levels and all were asymptomatic.

“The health and safety of participants in our clinical trials is of utmost importance to us,” said Andrew Crockett, Chief Executive Officer of KalVista. “We made the difficult decision to terminate KOMPLETE because we concluded that the emerging safety profile of the current formulation will not meet our requirements for a best-in-class oral prophylactic therapy. This termination conserves our financial resources and allows us to focus on continuing to advance sebetralstat through the ongoing phase III program and towards a planned 2024 NDA filing, as well as on our emerging oral Factor XIIa inhibitor program as a potential once daily prophylactic therapy for people with HAE.”

The KOMPLETE trial is a phase II clinical trial evaluating KVD 824, an investigational oral plasma kallikrein inhibitor designed for the prevention of attacks in adults living with HAE. Patients in the trial were randomized to one of three treatment groups, each placebo controlled: 300 mg, 600 mg, 900 mg KVD 824 (or placebo), all dosed twice daily. A total of 33 patients were enrolled in the trial, of which 7 patients experienced either Grade 3 or Grade 4 elevations of liver enzymes at timeframes ranging from two to twelve weeks. The elevations were noted in all treatment groups. One additional Grade 4 elevation was recorded in a patient at the baseline visit, prior to receiving study drug. KalVista will proceed to finalize the database of the trial and assess the unblinded data for efficacy and safety to determine the potential for any further development.