RAPIDe-1, a phase 2 trial evaluating the deucrictibant immediate-release (IR) capsule (PHVS416) for the treatment of angioedema attacks in patients with hereditary angioedema (HAE), has successfully achieved its primary objective as well as all key secondary endpoints.
This significant milestone has provided compelling evidence regarding the efficacy and safety of the deucrictibant IR capsule in effectively managing HAE attacks, demonstrating its potential as an on-demand therapy for HAE.
The primary endpoint of RAPIDe-1 is change in the 3-symptom composite visual analogue scale (VAS-3) score from pretreatment to 4 hours post-treatment.
Key secondary endpoints included time to onset of symptom relief by VAS-3 equal to or greater than 30% reduction, time to VAS-3 equal to or greater than 50% reduction, time to almost complete or complete symptom relief by VAS-3, change in mean symptom complex severity at 4 hours, and treatment outcome score at 4 hours.
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Treatment-related adverse events within 48 hours after administration of deucrictibant IR capsule included headache, nausea, vomiting, fatigue, and blister.
To be included in RAPIDe-1, participants needed to have a confirmed diagnosis of type 1 or 2 HAE and have experienced a minimum of 3 attacks in the last 4 months or at least 2 attacks in the last 2 months before screening. They were also required to have access to on-demand medications and prior experience in using them.
The primary analysis included 147 qualifying HAE attacks treated by 62 patients who received double-blinded placebo or a deucrictibant IR capsule at doses of 10, 20, or 30 mg.
The analysis followed a modified intent-to-treat approach, including all randomized patients who had at least 1 treated HAE attack and provided nonmissing VAS results pretreatment and at least 1 post-treatment time point of the attack.
Overall, these results lay a strong foundation for deucrictibant IR capsule continued development and bring new hope to patients suffering from HAE.
The results were recently presented at the European Academy of Allergy & Clinical Immunology (EAACI) Hybrid Congress 2023 in Hamburg, Germany.
Maurer M, Anderson J, Aygören-Pürsün E, et al. Efficacy and safety of oral administered bradykinin B2 receptor antagonist deucrictibant immediate-release capsule (PHVS416) in treatment of hereditary angioedema attacks: topline results of RAPIDe-1 phase 2 trial. Poster presented at: European Academy of Allergy & Clinical Immunology (EAACI) Hybrid Congress 2023, Hamburg, Germany; June 9-11, 2023.