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Shares of KalVista Pharmaceuticals (NASDAQ: KALV) are up over 175% premarket after the company reported positive topline data from its Phase 2 clinical trial of KVD900 as an oral on-demand treatment for hereditary angioedema (HAE) attacks.

KalVista’s stock price is trading at $43 premarket, up 175.46%. 

“We are very excited to share this positive data which shows that KVD900 is the first oral therapy to achieve clinical efficacy results comparable to current injectable therapies, while also demonstrating a promising safety and tolerability profile,” commented Andrew Crockett, CEO of KalVista. 

The Phase 2 randomised, double-blind, placebo-controlled crossover clinical trial evaluated the efficacy and safety of KVD900 as an on-demand treatment for HAE attacks. The trial enrolled 53 adult HAE patients at 25 clinical sites in the United States and Europe, Including type 1 and 2 HAE patients who had three attacks in 90 days before enrollment.

The data found that:

  • Attacks treated with KVD900 significantly reduced use of rescue, with 15% of KVD900 treated episodes rescued compared to 30% on placebo at 12 hours
  • KVD900 significantly reduced time to onset of symptom relief
  • KVD900 treated attacks achieved symptom relief more quickly than placebo-treated attacks
  • Within 12 hours of oral administration, KVD900 significantly increased the number of stabilised or improved attacks
  • KalVista added that additional exploratory endpoints were also statistically significant, while there were no serious adverse events reported

“Today’s data show that KVD900 halts HAE attack progression and also provides rapid relief by shortening the time to symptom resolution,” said Dr Emel Aygören-Pürsün, Principal Investigator for the KVD900 Phase 2 Clinical Trial and Head of the HAE Center at the University Hospital Frankfurt.

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