FDA Lifts Clinical Hold On KalVista's Hereditary Angioedema Trial

• The FDA has lifted the clinical hold on KalVista Pharmaceuticals Inc's (NASDAQ: 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.

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