KalVista Says FDA Lifts Clinical Hold On Phase 2 Clinical Trial Of KVD824 For Hereditary Angioedema

(RTTNews) - KalVista Pharmaceuticals, Inc. (KALV) announced Tuesday that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold on the Company's Phase 2 clinical trial of KVD824 for oral prophylactic treatment of hereditary angioedema (HAE).

The execution of KOMPLETE, the Phase 2 clinical trial for KVD824, as a potential oral prophylactic therapy for HAE, is expected to accelerate now at U.S. trial sites.

The previously announced 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.

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 and conducted at more than 30 sites in 13 countries.