KalVista Shares Plunge After Ending KVD824 HAE Trial Over Elevated Liver Enzymes In Patients

  • KalVista Pharmaceuticals Inc KALV has terminated the KOMPLETE phase 2 trial for KVD824 to prevent attacks in people with hereditary angioedema (HAE). 
  • This decision was based on observing liver enzyme (ALT/AST) elevations in multiple patients in all trial treatment groups. 
  • No patients had a concomitant elevation of bilirubin levels, and all were asymptomatic.
  • The company says that the termination conserves financial resources to focus on advancing sebetralstat through the ongoing phase 3 program and towards a planned 2024 NDA filing, as well as on an emerging oral Factor XIIa inhibitor program as a potential once-daily prophylactic therapy for people with HAE.
  • A total of 33 patients were enrolled in the trial, of which seven patients experienced either Grade 3 or Grade 4 elevations of liver enzymes. 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.
  • KalVista continues to recruit the phase 3 KONFIDENT trial assessing sebetralstat (formerly KVD900) as a potential oral, on-demand therapy for HAE attacks, with data anticipated in the second half of 2023. 
  • Price Action: KALV shares are down 51% at $6.97 during the premarket session on the last check Tuesday.
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