Initiation of KVD 900 phase III KONFIDENT clinical trial of oral treatment for hereditary angioedema attacks.- KalVista Pharma

This worldwide, double-blind, placebo-controlled crossover trial will evaluate the efficacy of two dose levels of KVD 900 compared to placebo in adolescents and adults experiencing acute HAE attacks. KVD 900 is the most advanced potential oral on-demand therapy for HAE in clinical development, and is intended to provide a substantial improvement over the current on-demand therapies for HAE attacks, which are all delivered by injection.

“Beginning the KONFIDENT trial represents a major milestone for KalVista,” said Andrew Crockett, Chief Executive Officer of KalVista. “We believe that KVD 900 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. Based upon the results of our Phase II study released last year, we expect that KVD 900 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. 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.”

The Phase III KONFIDENT trial is a worldwide clinical study being conducted at approximately 60 sites in 20 countries. The trial is intended to enroll a minimum of 84 HAE adolescent and adult patients who will complete treatment of three attacks: one each with 300 mg KVD 900, 600 mg KVD 900 and placebo in a double-blinded, randomized sequence. The primary endpoint of the trial is time to the beginning of symptom relief, evaluated on a Patient Global Impression of Change (PGI-C) scale, and additional endpoints will evaluate other measures of patient response and attack progression, as well as safety. Patients will dose upon first recognition of an attack, and all attack types including laryngeal attacks will be eligible for treatment. Patients will be permitted to take an additional dose of investigational drug, if symptoms warrant, and will always have access to their conventional injectable therapy. Study participants also will be allowed to maintain their prophylaxis regimen if they were receiving one at study enrollment. KalVista currently anticipates that data from KONFIDENT will be available in the second half of 2023 and will provide further updates as the trial progresses.