Shire PLC has published results from its Phase 1b lanadelumab study in the New England Journal of Medicine.
"The overall results of this study are encouraging; it should be noted that while the duration of treatment was relatively short and only a small number of patients were investigated, the results supported further Phase 3 investigations, which are currently ongoing," Dr. Paula Busse, associate professor at Mount Sinai Hospital, said.
Lanadelumab, a human monoclonal antibody, is administered subcutaneously. The drug binds and inhibits plasma kallikrein, which will hopefully prevent angioedema attacks in patients with hereditary angioedema (HAE). HAE is a rare genetic disorder that results in recurrent, localized edema.
"In this Phase 1b study, no serious adverse events or discontinuations due to adverse events were observed at all doses studied,” Dr. Aleena Banerji, associate professor at Massachusetts General Hospital in Boston, said in a statement. “Pre-specified efficacy analyses in patients with at least two attacks in the three months prior to enrolment demonstrated that from Day 8 to Day 50, the administration of two doses of lanadelumab (300 or 400 mg) 14 days apart, reduced the rate of attacks by 100 percent and 88 percent, respectively, when compared with placebo. In addition, all subjects were attack-free in the 300 mg group and 82 percent were attack-free in the 400 mg group, compared to 27 percent in the placebo group.”