Investors Cheer Positive Data From KalVista's KVD900 Mid-Stage Hereditary Angioedema Trial

  • Kalvista Pharmaceuticals Inc's (NASDAQ: KALV) oral plasma kallikrein inhibitor, KVD900, has reduced the use of rescue medication in patients suffering swelling attacks associated with hereditary angioedema (HAE), a disorder that results in recurrent episodes of severe swelling that most commonly affects the arms, legs, face, intestinal tract, and airway and is usually not itchy.
  • The phase 2 clinical trial enrolled 53 adult HAE patients who had experienced three attacks in the 90 days before recruitment. All patients received a single, open-label 600-mg dose of KVD900 in the first stage of the study before being randomized to get the drug or placebo in the second crossover stage. The second stage tracked patients until they had two attacks to compare KVD900 to placebo.
  • Fifteen percent of attacks treated with KVD900 required rescue medication in the 12 hours after onset, versus 30% of attacks in the placebo arm. The difference was statistically significant, causing the trial to hit its primary endpoint. The trial also linked KVD900 to reduced use of rescue medication at 24 hours.
  • The median time to symptom relief in patients on KVD900 was 1.6 hours, comparing favorably to the nine hours for placebo. The time to symptom relief with KVD900 is in line with an injectable alternative, Ruconest, which typically takes 1.5 hours to ease an attack's effects.
  • KalVista is now planning to hold an end-of-phase 2 meeting with the FDA before moving into phase 3.
  • Price Action: KALV stock rallied 167% at $41.8 on the last check Tuesday.

Posted In: hereditary angioedemaPhase 2 TrialRuconestBiotechNewsSmall CapFDAGeneral

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