Core Insights - Pharvaris is advancing its late-stage development of deucrictibant, an oral bradykinin B2 receptor antagonist, aimed at treating bradykinin-mediated diseases such as hereditary angioedema (HAE) and acquired angioedema due to C1 inhibitor deficiency (AAE-C1INH) [1][14] - The company presented data at the European Academy of Allergy and Clinical Immunology (EAACI) Congress 2025, highlighting the efficacy and safety of deucrictibant in both prophylactic and on-demand treatment settings [2][5] Prophylaxis - The CHAPTER-1 open-label extension study demonstrated long-term safety and efficacy of oral deucrictibant for prophylaxis in HAE, with participants experiencing sustained attack reduction and improved health-related quality of life (HRQoL) [5][6] - All participants reported clinically meaningful improvements in HRQoL, maintained up to week 62 of the study [5] - The ongoing CHAPTER-3 Phase 3 study is designed to evaluate the efficacy and safety of a once-daily, oral deucrictibant extended-release tablet for HAE prophylaxis [5][4] On-Demand Treatment - The RAPIDe-2 extension study provided evidence of the long-term safety and efficacy of oral deucrictibant for treating HAE attacks, with a median time to onset of symptom relief of 1.1 hours and 97.8% of attacks achieving symptom relief within 12 hours [10][7] - Deucrictibant was well tolerated, with no treatment-related adverse events reported, and 89.2% of attacks that achieved symptom resolution at 24 hours were treated with a single dose [10][8] - The RAPIDe-3 study is the first Phase 3 on-demand study to explore 'end-of-progression' as a new pre-specified endpoint, which is significant for HAE patients [2][5] Expansion Beyond HAE - Pharvaris is exploring the potential of deucrictibant beyond HAE, with ongoing studies validating a novel kinin biomarker assay for characterizing bradykinin-mediated pathologies [9][16] - A real-world survey indicated that patients prescribed long-term prophylaxis (LTP) experienced more mild attacks and better HRQoL compared to those on on-demand treatment (ODT) alone, supporting the importance of both treatment modalities in HAE management [10]

Core Insights - Pharvaris is advancing its late-stage clinical development of deucrictibant, a novel oral bradykinin B2 receptor antagonist aimed at treating bradykinin-mediated diseases such as hereditary angioedema (HAE) and acquired angioedema due to C1 inhibitor deficiency (AAE-C1INH) [1][18] - The company plans to present pivotal data readouts for deucrictibant in the next 18 months, highlighting its commitment to addressing unmet medical needs in this area [2][4] Prophylaxis - The ongoing Phase 2 CHAPTER-1 open-label extension study shows that oral deucrictibant maintains a low attack rate for over a year and a half, regardless of baseline attack rates [3] - Participants in the CHAPTER-1 study reported significant improvements in health-related quality of life (HRQoL) and treatment satisfaction, with all participants indicating well-controlled HAE [4] - A pharmacokinetics study demonstrated that the extended-release (XR) formulation of deucrictibant supports once-daily dosing, showing a four-fold higher mean plasma concentration than the therapeutic threshold at 24 hours [5][7] On-Demand Treatment - A post-hoc analysis of the RAPIDe-1 and RAPIDe-2 trials indicated that 95-100% of HAE attacks treated with a single dose of deucrictibant achieved symptom relief without recurrence [9] - The median time to onset of symptom relief was reported as 1.1 hours, with 97.8% of attacks achieving relief within 12 hours [10][11] - Deucrictibant was well tolerated across various attack types, including upper airway attacks, with no treatment-related adverse events reported [11] Expansion Beyond HAE - Pharvaris is exploring a novel biomarker assay for diagnosing bradykinin-mediated angioedema, which could enhance the identification and management of related conditions [12] - The company is also assessing the patient experience and outcome measures for AAE-C1INH, aiming to develop a conceptual model to support clinical assessments [14] - A systematic literature review estimated the prevalence of HAE-C1INH in the EU and UK to be between 0.05-0.33 per 10,000 individuals, indicating a significant need for effective treatments [15]

Core Insights - Pharvaris is expanding the potential treatment applications of deucrictibant for individuals with bradykinin-mediated angioedema, including hereditary angioedema (HAE) and acquired angioedema due to C1 inhibitor deficiency [1][2] - The company will host a virtual R&D call to discuss the pathophysiology, prevalence, current treatment paradigms, unmet needs, and the potential of deucrictibant [2] - Pharvaris aims to provide injectable-like efficacy and placebo-like tolerability through an oral therapy for bradykinin-mediated angioedema attacks [3] Company Overview - Pharvaris is a late-stage biopharmaceutical company focused on developing oral bradykinin B2 receptor antagonists to address various types of bradykinin-mediated angioedema [3] - The company is currently conducting pivotal Phase 3 studies to evaluate the efficacy and safety of deucrictibant for both the prevention and on-demand treatment of HAE attacks [3] Event Details - The virtual event titled "Deucrictibant: Beyond HAE Type 1/2" is scheduled for June 4, 2025, at 8:00 a.m. ET/14:00 CET [1][2] - Registration for the live webcast is available on the company's website, with an archived replay accessible for at least 30 days post-event [2]