Pharvaris Anticipates Significant Topline Results in 2025
Pharvaris Sets New Timeline for Topline Results of RAPIDe-3 Study
Pharvaris (Nasdaq: PHVS), a biopharmaceutical company focused on developing innovative treatments for bradykinin-mediated diseases, has made an important update regarding the timing of topline data from their pivotal Phase 3 study known as RAPIDe-3. The company now expects to announce these significant results in the fourth quarter of 2025. This study evaluates the potential of deucrictibant, an immediate-release capsule designed for the on-demand management of hereditary angioedema (HAE) attacks.
The Importance of RAPIDe-3
The RAPIDe-3 study aims to provide crucial insights into the effectiveness of deucrictibant for reactions commonly seen in patients suffering from angioedema. It will include a diverse group of around 120 participants, focusing on individuals aged 12 and older, including those with different types of HAE. The primary measure of success in this study will be the time it takes for patients to experience relief from symptoms, as rated by their own perceptions of change. Pharvaris is dedicated to examining the treatment's ability to not only alleviate symptoms but also to achieve complete symptom resolution with just one dose.
Berndt Modig, the CEO of Pharvaris, expressed optimism about the forthcoming data, highlighting the significance of combining efficacy with safety and convenience in treatment for HAE patients. He mentioned, “The attack data in RAPIDe-3 have continued to accrue following the achievement of target enrollment in the study; we now estimate that our RAPIDe-3 topline data announcement will be in the fourth quarter of this year.” This aligns with the company's goal to address the needs of those seeking effective treatments that minimize the burden of management for these serious conditions.
Research and Development Initiatives
Dr. Peng Lu, the Chief Medical Officer of Pharvaris, also underlined the study's broader implications, stating that it encompasses not just adults with HAE types 1 and 2, but also adolescents and patients with normal C1 inhibitor levels. The goal is to explore not only efficacy but also safety profiles, especially in more vulnerable populations.
Pharvaris continues to build its clinical momentum, supported by positive data from its earlier Phase 2 trials that address prophylactic treatment and on-demand responses to HAE attacks. The company is moving towards submitting a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) as early as the first half of 2026, contingent on the outcomes of the RAPIDe-3 study.
Overview of Deucrictibant
Deucrictibant is a novel bradykinin B2 receptor antagonist that is currently undergoing clinical trials. This medication aims to provide patients with the ability to manage their angioedema attacks effectively and promptly. Pharvaris is working on two formulations: an immediate-release capsule for rapid relief during attacks and an extended-release tablet for preventive measures. The promising characteristics of deucrictibant, particularly its potential to reduce the frequency and severity of attacks, have earned it orphan drug status from the FDA.
Company and Mission
As a late-stage biopharmaceutical entity, Pharvaris is committed to advancing treatments that can transform the lives of those affected by bradykinin-mediated diseases. The company endeavors to deliver injectable-like effectiveness with the ease of oral treatments, addressing the urgent requirements of patients affected by debilitating conditions like HAE. Pharvaris is actively engaged in ensuring that they bring forward options that are not only effective but also convenient for patients, paving the way for a significant shift in treatment paradigms.
Frequently Asked Questions
What is the primary focus of the RAPIDe-3 study?
The RAPIDe-3 study focuses on evaluating the efficacy of deucrictibant for on-demand treatment of hereditary angioedema (HAE) attacks.
When does Pharvaris expect to release the topline data?
Pharvaris anticipates releasing the topline data in the fourth quarter of 2025.
What is the potential submission date for the New Drug Application?
Pharvaris plans to submit a New Drug Application to the FDA in the first half of 2026 contingent on positive data.
What makes deucrictibant unique?
Deucrictibant is a small-molecule bradykinin B2 receptor antagonist designed to provide rapid relief from angioedema attacks, available in efficient oral tablets.
Who is eligible to participate in the RAPIDe-3 study?
Participants aged 12 and older, including those with different types of HAE, can participate in the RAPIDe-3 study.
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