“Thanks to our recent equity financing and the exciting Phase 1 data from our HAE candidate KVD900, we are pleased to announce that we are building on these successes with a more aggressive development plan for KVD900, to potentially accelerate our time to market,” says Andrew Crockett, CEO of KalVista Pharmaceuticals, Inc. “Our first step has been to design a larger Phase 2 clinical trial for KVD900 as on-demand treatment for HAE attacks in patients to generate more robust data that we intend to use as the basis for discussions with the FDA about a faster approval pathway. We still plan to initiate this trial before year-end, with data anticipated in late 2019. This Phase 2 trial will also benefit from our recently completed food effect study, which showed that dosing following a meal had no significant impact on the pharmacodynamic profile of KVD900. We do not expect food to impose any limitations as to when a patient can take the drug.
The food effect cohort of our Phase 1 study evaluated the impact of food on the pharmacokinetic profile of KVD900 in healthy volunteers. The Phase 1 study of KVD900 included a total of 68 subjects on active drug, of which 18 received the top dose of 600 mg, including the cross-over food effect cohort. Dosing following a standardized high calorie and high-fat meal had little impact on the pharmacodynamic profile of KVD900 tablets, which continued to result in 95% inhibition of plasma kallikrein within 30 minutes, a timeframe that we believe potentially compares favorably to approved injected therapies.”
KalVista believes that KVD900 displays a profile well-suited for use as an on-demand therapy for HAE attacks, with a combination of rapid and high uptake into the plasma resulting in fast and strong inhibition of plasma kallikrein. To date, KVD900 has shown no dose-limiting safety signals.
The enlarged Phase 2 trial evaluating the utility of KVD900 as an on-demand treatment for HAE attacks is expected to initiate before the end of 2018 and is expected to investigate efficacy in approximately 50 type 1 and 2 HAE patients. This two-part study will include an in-patient investigation of safety, pharmacokinetic and pharmacodynamic profile of KVD900 and an out-patient cross-over phase to investigate the efficacy of KVD900 versus placebo. KVD900 or placebo will be dosed within one hour of the start of an attack, with symptom severity monitored for at least 24 hours following administration. Patients will use their normal, on-demand treatment if the attacks worsen. Data is expected from this trial in late 2019, and KalVista will provide more information on the details of the trial design once the trial has initiated.