Pharvaris HAE drug shows faster symptom relief in Lancet study
A recent study published in The Lancet has revealed that Pharvaris' new drug, deucrictibant immediate-release capsule, provides faster relief for hereditary angioedema symptoms compared to a placebo. The phase 3 RAPIDe-3 study, a randomized, double-blind, placebo-controlled crossover trial, evaluated the drug's effectiveness in treating acute HAE attacks in both adolescents and adults.
The results showed that deucrictibant IR led to symptom relief onset in just 1.28 hours, significantly quicker than the 11.95 hours it took for placebo-treated patients to experience symptom resolution. The drug was also successful in halting the progression of attack symptoms and providing complete relief faster than the placebo. Remarkably, most attacks were controlled with a single capsule, indicating a highly effective treatment option.
The safety profile of deucrictibant IR was also found to be excellent, with no safety signals observed throughout the study. This well-tolerated nature of the drug across various subgroups, including different ages, geographical locations, HAE types, and attack severities, further supports its potential as a reliable treatment choice for hereditary angioedema patients.
Marc A. Riedl, a professor at the University of California San Diego and principal study investigator, emphasized that bradykinin B2 receptor antagonism, the drug's mechanism of action, is a widely accepted and reliable approach for managing HAE attacks on-demand.
Further progress is being made in the drug's development, with an open-label extension study (RAPIDe-2) currently underway and an expanded access program already available in the U.S. for eligible patients. Additionally, a New Drug Application for deucrictibant IR is under review by the FDA, with a target action date of April 23, 2027, and a Marketing Authorization Application is being assessed by the European Medicines Agency.
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