KalVista Pharmaceuticals, Inc. provides an update on the clinical trial progress for KVD900 in development for oral on-demand treatment of HAE.
“We had a productive End-of-Phase 2 meeting with the FDA and recently received meeting minutes which confirmed that our Phase 3 trial design, similar to our recent successful Phase 2 trial, is expected to be appropriate to support an NDA submission,” says Andrew Crockett, CEO of KalVista. “Our development team is finalizing the Phase 3 trial protocol and preparing for study initiation, and we anticipate patients will be dosed during the first quarter of 2022. KalVista is well-capitalized, with funding until at least early 2024, which we expect takes us beyond data from both this Phase 3 trial and the ongoing Phase 2 trial of KVD824.”
The Phase 3 clinical trial of KVD900 is a crossover design evaluating dose levels of 300 mg and 600 mg KVD900 against placebo. The primary endpoint of this Phase 3 trial is time to beginning of symptom relief. The trial is expected to be conducted at more than 50 sites worldwide and recruit approximately 100 patients, consistent with late stage trials of approved on-demand treatments for HAE. The trial is intended to evaluate all HAE attacks, including laryngeal attacks and breakthrough attacks for patients using prophylaxis. Similar to the Phase 2 trial for which positive data was announced earlier in 2021, patients will administer treatment as soon as they recognize the onset of an attack.