16 November 2018 - - US-based pharmaceutical company KalVista Pharmaceuticals, Inc. (NASDAQ: KALV) has provided an update on the hereditary angioedema candidate KVD900, the company said.

The food effect cohort of KalVista's 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 600mg, including the cross-over food effect cohort.

Dosing following a standardised 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 KalVista believes 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 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.

KalVista Pharmaceuticals is a pharmaceutical company focused on the discovery, development, and commercialization of small molecule protease inhibitors for diseases with significant unmet need.

The initial focus is on inhibitors of plasma kallikrein, which is an important component of the body's inflammatory response and which, in excess, can lead to increased vascular permeability, edema and inflammation.

KalVista has developed a proprietary portfolio of novel, small molecule plasma kallikrein inhibitors initially targeting hereditary angioedema and diabetic macular edema.

The company has created a structurally diverse portfolio of oral plasma kallikrein inhibitors and is advancing multiple drug candidates into Phase 1 clinical trials for HAE.

KalVista has selected KVD900 as its program to be advanced as an on-demand therapy for HAE attacks, and anticipates commencing a Phase 2 proof-of-concept study in HAE patients in late 2018.

In DME, KalVista's most advanced program, an intravitreally administered plasma kallikrein inhibitor known as KVD001, began a Phase 2 clinical trial in 2017 that is anticipated to report data in the second half of 2019.