FDA Puts Clinical Hold on KalVista’s HAE Therapy

Rare Daily Staff

The U.S. Food and Drug Administration placed a clinical hold on the proposed phase 2 clinical trial of KalVista Pharmaceuticals’ experimental hereditary angioedema therapy KVD824.

The company submitted an Investigational New Drug Application earlier this year for a phase 2 clinical trial to evaluate KVD824 as a potential prophylactic treatment for the prevention of HAE attacks.

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.

KVD824 is a twice-daily oral plasma kallikrein inhibitor in development for prevention of HAE attacks.

In a letter to the company, the FDA requested 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 company said no new studies were requested nor was it suggested that new data be generated to initiate the phase 2 trial.

“We intend to fully comply with the requests and recommendations provided by the FDA,” said Andrew Crockett, CEO of KalVista. “Although we no longer can confirm that the KVD824 phase 2 trial will initiate this quarter, we are working to resolve their concerns in a timely fashion. Importantly, this letter relates solely to KVD824, and does not impact our activities or expectations with regard to KVD900, for which we continue to prepare for an end of phase 2 FDA meeting and commencement of our phase 3 efficacy trial.”

KalVista has previously reported data from first-in-human and formulation studies of KVD824 that were conducted in the United Kingdom. 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. In both studies adverse event rates were similar in placebo and active arms, no subjects withdrew, and no serious adverse events were reported.

Photo: Andrew Crockett, CEO of KalVista