Core Insights - Pharvaris is advancing the clinical development of deucrictibant, a novel oral bradykinin B2 receptor antagonist, for the prevention and treatment of hereditary angioedema (HAE) attacks [1][9] - The company plans to initiate the pivotal Phase 3 study, CHAPTER-3, for prophylactic treatment of HAE by the end of 2024 [1][3] - Recent presentations at medical congresses highlighted positive long-term extension data for deucrictibant, reinforcing its differentiated profile and potential efficacy [2][3] Clinical Development Updates - CHAPTER-3 is a randomized, double-blind, placebo-controlled Phase 3 study aimed at enrolling approximately 81 participants aged 12 years and older, with a primary endpoint focused on the efficacy of deucrictibant compared to placebo [3] - Enrollment in the RAPIDe-3 study, a global pivotal Phase 3 study for on-demand treatment of HAE, is progressing as planned with a target of approximately 120 participants [3] - Long-term prophylaxis data from the CHAPTER-1 OLE study showed a 93% reduction in attacks compared to baseline, while the RAPIDe-2 OLE study indicated a median onset of symptom relief in approximately 1.1 hours [3][4] Financial Position - As of September 30, 2024, the company reported cash and cash equivalents of €305 million, down from €391 million at the end of 2023 [6] - Research and Development expenses for Q3 2024 were €25.8 million, an increase from €18.5 million in Q3 2023, while General and Administrative expenses rose to €12.1 million from €7.7 million in the same period [6] - The company reported a loss of €41.7 million for Q3 2024, with a basic and diluted loss per share of €0.77, compared to a loss of €23.6 million and a loss per share of €0.58 in Q3 2023 [6] Future Plans - The company intends to expand the clinical development of deucrictibant into acquired angioedema due to C1-INH deficiency (AAE-C1INH) following promising data from an investigator-initiated trial [4] - Upcoming investor events include participation in the Evercore ISI's 7th Annual HealthCONx Conference and the Oppenheimer Movers in Rare Disease Summit [5]
Pharvaris Reports Third Quarter 2024 Financial Results and Highlights Recent Business Updates