Benzinga | Feb 9, 2021 06:38AM EST

KalVista Pharmaceuticals Reports Positive Results for KVD900 Phase 2 Demonstrating Statistically and Clinically Significant Responses Across All Endpoints as an Oral On-Demand Treatment for HAE Attacks

-- Oral KVD900 Primary Endpoint Shows Only 15% Use of Rescue Medication in Patients with Hereditary Angioedema (HAE) --

-- KVD900 Generally Safe and Well-Tolerated --

-- Conference Call to Discuss Trial Results Today at 8:30 a.m. ET --

CAMBRIDGE, Mass. & SALISBURY, England--(BUSINESS WIRE)-- KalVista Pharmaceuticals, Inc. (NASDAQ:KALV), a clinical stage pharmaceutical company focused on the discovery, development, and commercialization of small molecule protease inhibitors, today announced positive topline data from a Phase 2 clinical trial demonstrating statistically and clinically significant efficacy of KVD900 as an oral on-demand treatment for hereditary angioedema (HAE) attacks.

"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. The rapid onset of symptom relief and significant reduction in the use of rescue medication show that patients can confidently take KVD900 at the earliest signs of an attack and avoid the burden and discomfort of injections," said Andrew Crockett, Chief Executive Officer of KalVista. "We look forward to working with regulatory agencies to bring the many advantages of 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."

The KVD900 Phase 2 was a randomized, double-blind, placebo-controlled, crossover clinical trial evaluating the efficacy and safety of KVD900 as an on-demand treatment for hereditary angioedema (HAE) attacks. The trial completed 53 adult HAE patients from 25 clinical sites in the United States and Europe. The trial included type 1 and type 2 HAE patients who had three attacks in 90 days prior to enrollment. During the first part of the two-part trial, patients received a single, open label 600 mg dose of KVD900 to evaluate pharmacokinetic and pharmacodynamic properties. All patients then entered part two of the trial, which was a double-blind investigation to assess the efficacy of KVD900 compared to placebo in a twoattack, crossover design. During part two of the trial, patients took a single dose of 600 mg of KVD900 or placebo within one hour of the start of the first attack. The second attack was dosed with the alternative crossover treatment. Patients were able to use their conventional rescue treatment, as required.