FDA Lifts Clinical Hold On KalVista's Hereditary Angioedema Trial

The FDA has lifted the clinical hold on KalVista Pharmaceuticals Inc's KALV Phase 2 trial of KVD824 for oral prophylactic treatment of hereditary angioedema (HAE).
Related Content: KalVista Stock Falls After FDA Institutes Clinical Hold On Hereditary Angioedema Trial With KVD824.
"The execution of KOMPLETE, our Phase 2 clinical trial for KVD824 as a potential oral prophylactic therapy for HAE, is expected to accelerate now that we can also proceed at our U.S. trial sites," said Andrew Crockett, Chief Executive Officer of KalVista.
The clinical hold was removed after the FDA review of KalVista's responses to the 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 48-subject KOMPLETE Phase 2 trial will evaluate twice-daily dosing of 300 mg, 600 mg, and 900 mg KVD824 against placebo for 12 weeks.
The primary endpoint of the trial is the rate of investigator confirmed HAE attacks during the treatment period.
Related content: Benzinga's Full FDA Calendar.
Price Action: KALV shares are trading 6.25% higher at $21.42 premarket on the last check Tuesday.