Phase 2 RAPIDe-1 trial results indicate treatment with oral bradykinin B2 receptor antagonist deucrictibant immediate-release capsule may provide quick symptom relief and hereditary angioedema (HAE) attack resolution, according to a poster published by Pharvaris.
The study was presented at the US HAEA National Summit in Orlando, Florida, this July.
The phase 2, double-blind, placebo-controlled, randomized, crossover, dose-ranging, RAPIDe-1 trial included 62 patients with HAE type 1 or 2 and 147 qualifying HAE attacks. Participants received a double-blinded placebo or deucrictibant immediate-release capsule of 10, 20, and 30 mg.
The researchers performed a primary modified intent-to-treat analysis and evaluated changes in mean symptom complex severity score and treatment outcome score from pretreatment to 4 hours post-treatment.
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According to the results, the deucrictibant immediate-release capsule quickly reduced the time to symptom relief, lessened the intensity of symptoms, and caused the resolution of HAE attacks. These clinically significant changes in HAE attack symptoms could be observed in the first few hours after oral deucrictibant immediate-release capsule administration. Moreover, the experimental drug significantly reduced the need for other rescue medications.
“Approved therapies for HAE attacks are administered parenterally with substantial treatment burden due to administration time and risk of pain or other injection site reactions, with the treatment of many attacks being delayed or forgone,” Anderson and colleagues emphasized.
“An unmet need exists for on-demand oral therapies that are effective and well-tolerated and may reduce the treatment burden enabling prompt administration as recommended by international clinical guidelines.”
However, clinical trials investigating deucrictibant for long-term HAE prophylaxis have been placed on hold by the US Food and Drug Administration (FDA). Deucrictibant is a specific bradykinin B2 receptor competitive antagonist, now formulated as an immediate-release capsule due to its high oral bioavailability.
Anderson J, Jacobs SJ, Li HH, et al. Treatment with oral bradykinin B2 receptor antagonist deucrictibant immediate-release capsule improves hereditary angioedema attack symptoms. Presented at: 2023 HAEA National Summit, Orlando, Florida; July 20-23, 2023.