15 September 2021 - - The US Food and Drug Administration has lifted the clinical hold on US-based clinical stage pharmaceutical company KalVista Pharmaceuticals, Inc's (NASDAQ: KALV) Phase 2 clinical trial of KVD824 for oral prophylactic treatment of hereditary angioedema, the company said.

The clinical hold was removed after FDA review of KalVista's responses to the FDA request for further information and analysis related to certain preclinical studies of KVD824.

Refinements were also made to the KVD824 Phase 2 KOMPLETE protocol.

The company is working closely with study investigators and clinical trial sites to proceed with all study activities as soon as possible.

KalVista has previously reported data from first-in-human and formulation studies of KVD824 that were conducted in the UK.

To date, a total of 121 subjects have received KVD824 as single doses up to 1280 mg and up to 14 days of twice-daily dosing of 600 mg and 900 mg.

Data from the Phase 1 studies indicate that KVD824 maintains the plasma concentrations that we believe are required to deliver efficacy consistent with approved injectable therapies. In both studies adverse event rates were similar in placebo and active arms, no subjects withdrew, and no serious adverse events were reported.

KOMPLETE is the Phase 2 clinical trial of KVD824, and is a randomized, double-blind, parallel group design evaluating twice-daily dosing of 300 mg, 600 mg, and 900 mg KVD824 against placebo for 12 weeks.

The trial is intended to enroll 48 HAE patients randomized into four equal arms after they report experiencing a minimum of three attacks in an eight-week run-in period.

The primary endpoint of the trial is the rate of investigator confirmed HAE attacks during the treatment period.

Secondary endpoints include the proportion of participants without investigator confirmed HAE attacks and the rate of investigator confirmed HAE attacks that require conventional treatment. KOMPLETE will be conducted at more than 30 sites in 13 countries.

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

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

KalVista is developing KVD900 as an oral on-demand therapy for acute HAE attacks, which completed a Phase 2 efficacy trial in February 2021, demonstrating statistical and clinical significance across all endpoints.

KVD824 is in development for prophylactic treatment of HAE with the Phase 2 KOMPLETE clinical trial underway.

In addition, KalVista's oral Factor XIIa inhibitor program represents a new generation of therapies that may further improve the treatment of HAE for patients.

In DME, an intravitreally administered plasma kallikrein inhibitor, called KVD001, has completed a Phase 2 clinical trial.