Phase 3 Trial of KVD900 as Oral, On-demand HAE Therapy Opening

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by Marisa Wexler MS |

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KalVista Pharmaceuticals has launched a Phase 3 trial, called KONFIDENT, to test the safety and effectiveness of KVD900, an experimental oral and on-demand treatment for swelling attacks in people with hereditary angioedema (HAE).

“Beginning the KONFIDENT trial represents a major milestone for KalVista,” Andrew Crockett, the company’s CEO, said in a press release.

KONFIDENT (NCT05259917) is expected to enroll at least 84 adults and adolescents, ages 12 and older, with HAE types 1 and 2 at some 60 sites in 20 countries around the world.

To be eligible, patients must have experienced at least two documented HAE swelling attacks in the three months before entering the study. Participants are allowed to continue on their established prophylactic (preventive) treatments.

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Over the course of the study, patients aware that a swelling attack is beginning will randomly be assigned to one of two doses of KVD900 (a 300 or 600 mg tablet) or a placebo tablet. Each intervention will be used, one each for three separate attacks, with all types of attacks eligible for treatment.

Patients will be allowed to take an additional dose of the investigational treatment if symptoms warrant, and they will also have access to their standard on-demand treatments.

KVD900 is unique among on-demand HAE treatments in that it is an oral therapy. Currently available on-demand treatments are delivered via injection.

The study’s main goal is to assess the time to the beginning of symptom relief, as measured with a Patient Global Impression of Change (PGI-C) scale. Other measures of treatment effectiveness in reducing swelling also will be assessed, as will safety.

“We believe that KVD900 has the potential to transform the treatment paradigm for HAE patients experiencing acute attacks, whether they primarily treat with on-demand medications or use long-term prophylaxis,” Crockett said. “Our goal is to provide patients with the confidence that their attacks will be controlled in the earliest stages and without the associated treatment pain and other challenges of injectable therapies.”

Results from a previous Phase 2 trial (NCT04208412), which enrolled 68 adults with type 1 or type 2 HAE with recurrent swelling attacks, indicated the experimental oral treatment could slow the progression of swelling attacks and hasten the time to symptom relief.

“Based upon the results of our Phase 2 study released last year, we expect that KVD900 can provide patients with symptom relief as rapidly as existing therapies, but with an oral tablet that will allow earlier treatment of all patient-recognized HAE attacks,” Crockett said.

HAE is characterized by the overactivity of a protein called kallikrein, which results in the excessive production of signaling molecules that trigger swelling. KVD900 is designed to inhibit kallikrein.

Recent data from a Phase 1 trial in healthy volunteers (NCT04349800) showed the oral therapy rapidly and nearly completely suppressed the protein’s activity.

KONFIDENT is expected to conclude in October 2023.