Swiss biopharmaceutical company, Pharvaris, has announced positive results from its pivotal RAPIDe-3 study, confirming the potential of its oral drug, deucrictibant, as an on-demand treatment for hereditary angioedema (HAE) attacks.
The data showed the drug met all primary and secondary efficacy endpoints with high statistical significance, paving the way for planned regulatory submissions in the first half of 2026.
Following the news, the company’s stock rose by 21.7% at market close on 3 December, compared to the market close on the previous day. Pharvaris completed a public offering of $201 million in July. As of September 30, 2025, it reported cash reserves of €329 million ($383.4 million), indicating that its cash runway extends well into the first half of 2027.
Compelling Efficacy Across Key Measures
The global RAPIDe-3 Phase III trial (NCT06343779) evaluated a single 20 mg immediate-release capsule of deucrictibant in 134 participants aged 12 and older across 24 countries. The study was designed to be broadly representative, including all major HAE subtypes and varying attack severities.
The primary endpoint, median time to onset of symptom relief, was achieved in 1.28 hours for deucrictibant, compared to over 12 hours for placebo. Perhaps even more striking was the speed in halting attack progression. The secondary endpoint “End of Progression” – a novel measure highlighted in the company’s investor presentation as a key differentiator – showed a median time of 17.47 minutes with the active drug versus 228.67 minutes for placebo.
Other secondary endpoints reinforced the rapid and durable effect. Median time to substantial symptom relief was 2.85 hours, and complete symptom resolution occurred in a median of 11.95 hours, compared to over 24 hours for placebo. Furthermore, 83% of attacks were controlled with a single capsule, and 93.2% required no rescue medication within 12 hours.
Safety Profile
The safety profile was consistent with prior studies. Deucrictibant was well-tolerated with no treatment-related serious adverse events and no participant discontinuations due to side effects.
Principal investigator Dr. Marc A. Riedl, from the University of California San Diego, noted the significance of the findings. “Effective, well-tolerated, and convenient acute treatment is an essential part of all HAE management plans,” he stated. “The comprehensive and compelling outcomes of RAPIDe-3… demonstrate the potential benefits of deucrictibant as an important on-demand treatment for people living with HAE.”
For Pharvaris, the RAPIDe-3 success is a major validation of its strategy. The company’s Chief Medical Officer, Dr. Peng Lu, emphasized that the study was designed to address the “unmet needs and high expectations” of all stakeholders. CEO Berndt Modig framed the results as part of a broader vision: “Deucrictibant combines the proven and effective mechanism of bradykinin B2 receptor antagonism in HAE with the convenience of oral administration.”
Road Ahead
The company presentation underscores that deucrictibant aims to be a dual-purpose therapy. While RAPIDe-3 supports its on-demand use, an ongoing Phase III trial, CHAPTER-3 (NCT06669754), is evaluating an extended-release formulation for long-term prophylaxis. Success there could position deucrictibant as the first and only oral therapy for both acute and preventive treatment of bradykinin-mediated angioedema.
HAE is a rare genetic condition causing unpredictable and potentially life-threatening swelling episodes. While treatments exist, patients often balance trade-offs between efficacy, tolerability, and convenience. Pharvaris highlights that oral administration could offer a significant advantage in convenience and accessibility over current injectable or intravenous options.
The company is now focused on compiling these data for regulatory filings. Pharvaris remains on track to submit a New Drug Application (NDA) to the US Food and Drug Administration (FDA) in the first half of 2026. Additional detailed results from the RAPIDe-3 study are expected to be presented at upcoming medical congresses. The ongoing open-label extension study, RAPIDe-2 Part B (NCT05396105, will continue to provide long-term safety and efficacy data.
