Pharvaris Provides Business Update and Expands Development Program for Deucrictibant

Core Insights - Pharvaris is set to initiate the pivotal Phase 3 clinical study, CHAPTER-3, for deucrictibant, aimed at the prophylactic treatment of hereditary angioedema (HAE) by the end of 2024 [1][2] - The company plans to expand the clinical development of deucrictibant to include acquired angioedema due to C1-inhibitor deficiency (AAE-C1INH) as a new indication [1][3] - The CEO of Pharvaris expressed confidence in deucrictibant's potential to become a preferred therapy for HAE management, supported by new long-term extension study data [2] Clinical Development - CHAPTER-3 will evaluate the efficacy and safety of once-daily dosing of deucrictibant extended-release tablets, designed to maintain therapeutic plasma levels for over 24 hours [2][3] - The study is on track to begin by the end of 2024, with startup activities progressing as planned [2] - Data from ongoing studies indicate that deucrictibant can provide injectable-like efficacy with favorable tolerability and convenience of oral administration [3] Research Findings - A recent investigator-initiated trial at Amsterdam UMC demonstrated that deucrictibant significantly reduced mean monthly attack rates in patients with AAE-C1INH, with no severe adverse events reported [3][4] - The results from this trial support the hypothesis that deucrictibant can effectively prevent and treat AAE-C1INH, addressing an unmet medical need [4] Upcoming Events - Pharvaris will present findings at the CIIC Fall 2024 Conference, including long-term efficacy and safety data from the RAPIDe-2 and CHAPTER-1 extension studies [6] - A live conference call will be held to discuss updates and data in detail, with presentation materials available on the company's investor relations website [7] Product Overview - Deucrictibant is a novel oral bradykinin B2 receptor antagonist, developed in both extended-release and immediate-release formulations for prophylactic and on-demand treatment of HAE [8][9] - The company aims to provide effective, well-tolerated, and easy-to-administer alternatives for patients with bradykinin-mediated angioedema [9]