FDA Lifts Hold, Allows Phase 2 Trial of KVD824 for HAE to Open
The U.S. Food and Drug Administration (FDA) has lifted the hold it had placed on KalVista Pharmaceuticals’ Phase 2 KOMPLETE trial of KVD824 as a treatment to prevent swelling attacks in people with hereditary angioedema (HAE).
KalVista said it is working closely with study investigators and clinical sites so that trial activities can get underway as soon as possible.
“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,” Andrew Crockett, KalVista’s CEO, said in a press release.
The FDA put a hold on the trial’s U.S. launch in April, requesting further analyses into preclinical studies of KVD824 and for some changes to the proposed trial’s protocol. The FDA, however, did not request new studies or data in its response to KalVista’s application to initiate the study.
KalVista submitted its response to the FDA last month, and announced plans to start enrolling patients in KOMPLETE at locations in Canada, Australia, and the U.K.
“Progress continues worldwide, with regulatory submissions complete in all of the countries where the trial will be conducted,” Crockett said.
KVD824 is an oral therapy designed to lower the levels of bradykinin, a signaling molecule that drives swelling in HAE. It works by blocking the activity of plasma kallikrein, an enzyme that normally increases bradykinin levels.
KOMPLETE will be conducted at more than 30 sites across 13 countries. It aims to enroll 48 people with HAE who have had at least three attacks over an eight-week, run-in period.
Patients will be randomly assigned to one of three doses of KVD824 (300, 600, or 900 mg) or to a placebo, taken twice a day for 12 weeks.
The trial’s main goal is to assess the impact of treatment on investigator-confirmed swelling attacks. Other outcomes relating to treatment efficacy and safety will also be assessed.
According to KalVista, 121 people have been treated with KVD824 at varying doses in early clinical trials that took place in the U.K., and safety results have been promising. The frequency of side effects was similar between those given the investigational medicine and those on a placebo, no one withdrew from these studies due to the treatment, and no serious side effects were reported.