Pharvaris N.V.(US:PHVS)2025-12-03 14:02Summary of RAPID-3 Topline Data Webcast Company and Industry - Company: Pharvaris - Industry: Biotechnology, specifically focusing on treatments for Hereditary Angioedema (HAE) Core Points and Arguments 1. Introduction of Deucrictibant: The RAPID-3 study is a phase 3 clinical trial for deucrictibant, an immediate release capsule designed for on-demand treatment of hereditary angioedema attacks [2][6] 2. Study Design: RAPID-3 was a double-blind crossover study involving 124 adults and 10 adolescents, treating various severities of HAE attacks [13][14] 3. Diversity of Participants: The study included a diverse population with approximately 70% Caucasians, over 14% Asians, and around 7% Black or African Americans, making it the most representative HAE study to date [14] 4. Efficacy Results: Deucrictibant demonstrated a median time to onset of symptom relief of 1.28 hours, significantly faster than placebo, which had a median time of over 12 hours [16][19] 5. Substantial Symptom Relief: 85% of deucrictibant-treated attacks achieved symptom relief within four hours, compared to around 30% for placebo [17] 6. End-of-Progression Milestone: The end-of-progression was achieved within 17.5 minutes for deucrictibant-treated attacks, indicating rapid absorption and effectiveness [18] 7. Safety Profile: Deucrictibant was well tolerated, with most adverse events being mild or moderate. There were no significant safety signals identified [19][20] 8. Market Positioning: Deucrictibant's dual formulation for both on-demand and prophylactic treatment is seen as a strategic advantage, potentially enhancing market share and patient adoption [24][25] 9. Future Plans: Pharvaris aims to submit for global marketing authorization for deucrictibant in the on-demand treatment of HAE attacks in 2026 [22][37] Other Important Content 1. Unmet Needs in HAE Treatment: Despite advancements in long-term prophylactic treatments, there remains a critical need for effective on-demand therapies due to the unpredictable nature of HAE attacks [9][10] 2. Patient-Centric Approach: The development of deucrictibant aligns with the company's mission to provide patient choice and reduce treatment burden [25][26] 3. Upcoming Data Presentations: Further data from the RAPID-3 study will be presented at the AAAAI conference in February 2024, with additional studies planned for the prophylactic treatment of HAE [26][37] 4. CYP3A4 Interaction: Deucrictibant is primarily metabolized by CYP3A4, and caution is advised when used with strong CYP3A4 inhibitors or inducers [32] 5. Patient Preferences: A significant majority (80%-85%) of patients expressed interest in switching to oral rescue treatments, although some may prefer injectable options due to familiarity and perceived effectiveness [50] This summary encapsulates the key findings and strategic insights from the RAPID-3 Topline Data webcast, highlighting the potential impact of deucrictibant on the treatment landscape for hereditary angioedema.