KalVista Pharmaceuticals has commenced the Phase III KONFIDENT clinical trial of oral KVD900 for the treatment of hereditary angioedema (HAE) attacks.
KVD900 is said to be the first potential oral, on-demand therapy for HAE.
It is designed to offer a significant improvement for HAE attacks versus the present on-demand therapies administered by injection.
The global, placebo-controlled, double-blind, crossover trial will analyse the safety and efficacy of two dose levels of KVD900 versus placebo to treat acute HAE attacks in adolescents and adult subjects.
Being carried out at nearly 60 study centres in 20 countries, the trial anticipates to enrol around 84 adolescents and adults with HAE.
In a double-blinded, randomised series, these subjects will complete treatment of three attacks: one each with 300mg KVD900, 600mg KVD900 and placebo.
The time to the commencement of relief in symptoms, as assessed on a Patient Global Impression of Change (PGI-C) scale will be the trial’s primary endpoint.
Analysing other measures of patient response and attack progression as well as safety will be other endpoints of the study.
The company expects to report results from the trial in the second half of next year.
KalVista CEO Andrew Crockett said: “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.
“Based upon the results of our Phase II 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-recognised HAE attacks.”
In September last year, the US Food and Drug Administration lifted the clinical hold placed on KalVista’s Phase II KOMPLETE trial of KVD824 as oral prophylactic for HAE.