Positive Results from CHAPTER-1 Phase 2 Study of Deucrictibant for the Prophylactic Treatment of HAE Attacks to be Presented at AAAAI 2024 Annual Meeting
Pharvaris today announced the upcoming presentation of two posters at the American Academy of Allergy, Asthma, & Immunology (AAAAI) 2024 Annual Scientific Meeting, to be held in Washington DC from 23-26 February 2024, at the Walter E. Washington Convention Center. The abstracts have been published in an online supplement to The Journal of Allergy and Clinical Immunology (JACI).
A poster, titled “Efficacy and Safety of Bradykinin B2 Receptor Antagonism with Oral Deucrictibant in Prophylaxis of Hereditary Angioedema Attacks: Results of CHAPTER-1 Phase 2 Trial,” will be presented by Marc A. Riedl, MD, MS, during the poster session on Friday, 23 February from 3:15-4:15 pm Eastern Standard Time (EST). CHAPTER-1 is a two-part, Phase 2 study evaluating the efficacy, safety, and tolerability of deucrictibant for long-term prophylaxis against angioedema attacks in HAE type 1 and type 2 (HAE-1/2). The study enrolled participants in Canada, Europe, the United Kingdom, and the United States. Eligible participants were between the ages of 18 and 75 years, diagnosed with HAE-1/2, were not receiving other prophylactic treatments, and experienced an average of at least one attack per month.
34 participants were treated with double-blinded study drug (placebo or deucrictibant, 20 or 40 mg/day) for 12 weeks of treatment. Analysis of the primary endpoint demonstrated that deucrictibant significantly reduced the monthly attack rate by 84.5% (p=0.0008) in participants dosed at 40 mg/day and 79.3% (p=0.0009) in participants dosed at 20 mg/day compared to placebo. Deucrictibant was well tolerated at both doses, and all reported treatment-related treatment-emergent adverse events (TEAEs) were mild in severity, and no serious TEAEs, no severe TEAEs leading to treatment discontinuation, study withdrawal, or death were reported.
Peng Lu, MD, PhD, Chief Medical Officer of Pharvaris, said: “The CHAPTER-1 study results show that deucrictibant is the first oral therapy with the potential to provide injectable-like efficacy with a favorable safety profile to prevent HAE attacks. These data validate the mechanism of deucrictibant to provide early and sustained protection from HAE attacks. Combined with the results of our Phase 2 on-demand study, RAPIDe-1, these results support the further development of deucrictibant, which could become the preferred option to both treat and prevent HAE attacks.”
A second poster, titled “Understanding the Reasons not to Treat All HAE Attacks and Patient Satisfaction for On-Demand Treatment (ODT). Results from the HAE Wave II Disease Specific Program™ (DSP™) 2023,” will be presented by Joan Mendivil, MD, during the poster session on Friday, 23 February from 3:15-4:15 pm EST.
(Source: Pharvaris)
