Shares of Kalvista Pharmaceuticals Inc KALV are sharply higher Tuesday following the release of a mid-Phase clinical readout.
What Happened: Kalvista, which focuses on developing small molecule protease inhibitors for diseases with significant unmet need, said KVD900, the most advanced compound in its pipeline, demonstrated statistically and clinically significant efficacy as an oral on-demand treatment for hereditary angioedema, or HAE, attacks in a Phase 2 study.
HAE is a rare genetic condition causing painful episodes of swelling in body parts, including airways of lungs or intestinal walls.
The two-part study evaluated the efficacy and safety of KVD900 in 53 adult HAE patients from 25 clinical sites in the U.S. and Europe. In part one of the study, subjects were administered a single, open-label 600mg dose to evaluate pharmacokinetic and pharmacodynamic properties, while in part two of the study, patients were randomized to receive a single dose of either 600mg KVD900 or placebo, within one hour of the start of the attack.
Top-line results showed that KVD900 significantly reduced use of rescue and its efficacy benefit was maintained at 24 hours. The investigational asset reduced the time to onset of symptom relief and also brought about symptom relief more quickly.
Additional exploratory endpoints were also statistically significant in the treatment arm, the company said.
KVD900 was also found to be safe, with no serious adverse events reported in the trial and no patients withdrew due to adverse events.
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Why It's Important: KalVista said the positive data showed KVD900 is the first oral therapy to achieve clinical efficacy results comparable to current injectable therapies.
"The results are highly encouraging. For patients, easy and efficacious oral on-demand treatment of attacks is now within reach," said Emel Aygören-Pürsün, principal investigator of the study.
The company also said it's working with regulatory agencies to bring KVD900 to patients as quickly as possible.
"In parallel, we remain committed to advancing our oral HAE franchise, with submission of an IND this quarter for KVD824 as a prophylactic treatment and ongoing preclinical work on our oral Factor XIIa program," it added.
KalVista shares were jumping 148.49% to $38.79.
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