FDA Lifts Clinical Hold on KalVista HAE Therapy
September 15, 2021
The U.S. Food and Drug Administration lifted a clinical hold on the proposed phase 2 clinical trial of KalVista Pharmaceuticals’ experimental hereditary angioedema therapy KVD824.
In April, the FDA placed a hold on the company’s phase 2 clinical trial to evaluate KVD824 as a potential prophylactic treatment for the prevention of HAE attacks. The agency wanted further information and analysis related to certain preclinical studies of KVD824 submitted to support the planned phase 2 trial. The agency also proposed refinements to the intended phase 2 study protocol.
The clinical hold was removed after FDA review of KalVista’s responses to the FDA request for further information and analysis. 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.
Hereditary angioedema (HAE) is a rare, genetic disorder that results in recurring attacks of swelling in various parts of the body, including the abdomen, face, feet, genitals, hands, and throat that can be can debilitating and painful. Attacks that obstruct the airways are potentially life-threatening due to the risk of asphyxiation.
“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, CEO of KalVista. “Progress continues worldwide, with regulatory submissions complete in all of the countries where the trial will be conducted.”
KalVista has previously reported data from first-in-human and formulation studies of KVD824 that were conducted in the U.K. 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 it believes 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.
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