Deucrictibant for angioedema attacks hits targets in phase III study

On-demand treatment with the oral bradykinin B2 receptor antagonist deucrictibant offers rapid control of symptoms in patients experiencing attacks of bradykinin-mediated angioedema, including hereditary angioedema, according to the phase III RAPIDe-3 study.

RAPIDe-3 included 134 adolescents and adults with hereditary angioedema (median age 38 years, 57 percent female, 68 percent White), including those with normal C1 inhibitor associated with a documented genetic variant, who experienced at least two attacks within the last 3 months before screening.

The participants were randomly assigned to treat a first attack with a 20- mg oral deucrictibant immediate-release capsule and a second attack with placebo (deucrictibant–placebo group) or a first attack with placebo and then a second attack with deucrictibant (placebo–deucrictibant group).

The primary endpoint was time to onset of symptom relief, defined as Patient Global Impression of Change rating of at least a little better. Safety was assessed in all participants who received any dose of the study drug.

A total of 113 participants treated 201 attacks, and the primary efficacy analysis included 88 participants with paired treated attacks.

Symptom relief occurred significantly faster with deucrictibant vs placebo, with median time of 1.28 vs 12 h (p<0.0001). Fatigue was the only adverse event (AE) that occurred more than once within 3 days post-treatment. There were no treatment-related AEs assessed as severe or serious, and none led to treatment discontinuation.

The findings indicate that deucrictibant may address an unmet need for treatment options that are effective and well tolerated, with convenient administration.