Pharvaris (Nasdaq: PHVS), a late-stage biopharmaceutical company developing oral bradykinin B2 receptor antagonists to help address unmet needs of those living with bradykinin-mediated angioedema, such as hereditary angioedema (HAE) and acquired angioedema due to C1 inhibitor deficiency (AAE-C1INH), summarized the presentations from the European Academy of Allergy and Clinical Immunology (EAACI) Annual Congress 2026, which took place from June 12-15, 2026, in Istanbul, Turkey.
“The data presented at EAACI continue to provide evidence supporting a potentially differentiated profile of deucrictibant in both the on-demand setting and the prophylactic setting,” said Berndt Modig, Chief Executive Officer of Pharvaris. “Pharvaris’ commitment to developing therapies that can meaningfully improve standard of care remains at the forefront of our work. We were pleased to be amongst those who contributed to the AURORA international consensus and are proud to have sponsored the first-ever on-demand HAE clinical study that assessed EoP as a prespecified efficacy endpoint.”
Peng Lu, M.D., Ph.D., President of Pharvaris, added, “The compelling topline efficacy data from RAPIDe-3, combined with the high proportion of attacks treated with a single capsule of deucrictibant, underscore the potential for deucrictibant to address unmet needs in the on-demand treatment setting. Additionally, in the prophylactic treatment setting, deucrictibant’s rapid and durable prevention of HAE attacks, well-tolerated profile, and sustained improvement in disease control and HRQoL reflect the potential for its broader positive impact as an effective and well-tolerated prophylactic treatment for HAE attacks.”
On-Demand Therapy
Oral Deucrictibant Immediate-Release Capsule for On-Demand Treatment of Hereditary Angioedema Attacks: Results of the Phase 3 RAPIDe-3 Trial was presented by Philip H. Li, M.D., FRCP. The RAPIDe-3 global Phase 3, placebo-controlled study (NCT06343779) evaluated orally administered deucrictibant immediate-release capsule (20 mg) for the on-demand treatment of attacks in participants 12 years and older with HAE, including those with HAE with normal C1 inhibitor. Results from RAPIDe-3 demonstrated the rapid and sustained efficacy of deucrictibant in treating HAE attacks. The median time to onset of symptom relief was 1.28 hours with deucrictibant treatment versus over 12 hours with placebo. The median time to complete resolution of attack symptoms was 11.95 hours with deucrictibant treatment versus over 48 hours with placebo. Importantly, the majority of deucrictibant-treated attacks achieved the efficacy endpoints with a single capsule. 83.0% of deucrictibant-treated attacks were treated with a single capsule of deucrictibant and 93.2% did not require conventional treatment as rescue medication. Deucrictibant was well tolerated with no treatment-related serious adverse events and no participants discontinuing treatment due to treatment-emergent adverse events.
Oral Deucrictibant Immediate-Release Capsule for On-Demand Treatment of Hereditary Angioedema Attacks: End of Progression Results in the Phase 3 RAPIDe-3 Trial was presented as an oral presentation by Mauro Cancian, M.D., Ph.D. RAPIDe-3 is the first and only study to date to have assessed End of Progression (EoP), a clinically meaningful measure of early treatment response defined as the earliest timepoint at which symptoms stop worsening, as a prespecified endpoint. Treatment with deucrictibant resulted in a median time to EoP of 17.47 minutes, compared with 228.67 minutes with placebo, and EoP was achieved within 12 hours in 92.8% of deucrictibant-treated attacks versus 60.9% of attacks treated with placebo. The majority of attacks achieving EoP reached this endpoint with a single capsule (97.4%) of oral deucrictibant.
RAPIDe-3 Patient Voices: Qualitative Insights from the Phase 3 Study of Oral Deucrictibant for On-Demand Treatment of Hereditary Angioedema Attacks was presented by Anna Valerieva, M.D., Ph.D. Qualitative in-trial interviews conducted with participants during the RAPIDe-3 study captured high-quality patient experience data, including insights into the experiences of people living with HAE related to their attacks and associated health-related quality of life (HRQoL) impacts. Overall, participants reported experiencing eight negatively impacted HRQoL domains with HAE attacks during the study; the most frequently reported were fatigue, emotional wellbeing, and activities of daily living. Despite using effective and well-tolerated HAE treatments in the past, 45.7% of participants reported that deucrictibant-treated attacks had improved treatment experience in day-to-day life compared with prior attacks treated with injectable standard-of-care HAE treatments.
Combination Treatment
Evaluations of Safety Margins and Response to Deucrictibant Extended-Release (XR) Tablet in Combination with Deucrictibant Immediate-Release (IR) Capsulewas presented by Anne Lesage, Ph.D. Data assessed human exposures across the anticipated dosing scenarios of deucrictibant IR in combination with deucrictibant XR and calculated the corresponding safety margins based on available clinical and nonclinical data. The analysis demonstrated that combined use of a 40 mg deucrictibant XR tablet for prophylaxis and one or two deucrictibant IR 20 mg capsule(s), in the event of a breakthrough attack while on prophylaxis, is supported by evidence of adequate safety margins.
Long-Term Prophylaxis
Results of the Phase 2 CHAPTER-1 Open-Label Extension Study on the Long-Term Safety and Efficacy of Oral Deucrictibant for Prophylaxis in Hereditary Angioedemawas presented by Markus Magerl, M.D. Final data from the completed open-label extension (OLE) of the Phase 2 CHAPTER-1 (NCT05047185) study investigating oral deucrictibant demonstrated sustained efficacy and a favorable long-term safety profile, with participants treated for up to ~34 months prior to rolling over to the CHAPTER-4 (NCT06679881), a long-term, open-label extension study of deucrictibant XR for the prophylactic treatment of HAE attacks. Deucrictibant was generally well tolerated, with no treatment-related serious adverse events, discontinuations, or clinically meaningful laboratory, vital sign, or ECG abnormalities reported. Treatment led to rapid and durable reductions in HAE attack rates, with attack frequency reduced on average by ~92% from study baseline and remaining low over time, and approximately half of participants being attack-free during the entire extension period.
CHAPTER-1 Open-Label Extension Study: Long-Term Prophylactic Treatment with Oral Deucrictibant Improved Disease Control and Health-Related Quality of Life in Participants with Hereditary Angioedema was presented by Markus Magerl, M.D. Findings from CHAPTER-1 provided evidence of sustained improvement in disease control, HRQoL, and treatment satisfaction in participants with HAE. Disease control improved rapidly and was durable, with 100% of participants reporting well-controlled disease during long-term treatment (Week 62 to end of study). Treatment satisfaction scores for effectiveness were higher versus placebo and remained consistently high through week 134. Clinically meaningful improvements in HRQoL were observed as by week four and were maintained through more than two years of treatment, with all participants reporting improved HRQoL during the OLE.
Cardiovascular Safety
Clinical Cardiovascular Safety Assessment of Oral Deucrictibant was presented by Anne Lesage, Ph.D. An integrated analysis assessed cardiovascular (CV) outcomes across all deucrictibant clinical studies with available data at the time of the analyses and included ~570 unique deucrictibant-treated participants. Deucrictibant had a favorable cardiovascular safety profile across the studies analyzed, with no evidence of QT prolongation or clinically meaningful cardiac risks observed. There were no reports of serious arrhythmias, QT prolongation, or sudden cardiac death and cardiovascular adverse events were infrequent and not considered treatment related. Hemodynamic parameters, including heart rate and blood pressure, remained stable, and no clinically meaningful ECG changes were observed.
“Cardiovascular safety is a critical consideration in development of therapeutics impacting the kallikrein-kinin system, particularly given bradykinin’s role in the contact pathway and vasoactive properties,” said Anne Lesage, Ph.D., Chief Early Development Officer at Pharvaris. “In this integrated analysis of multiple studies to date, deucrictibant has a cardiovascular profile showing no evidence of increased risks or of QT prolongation nor clinically meaningful cardiac risks. Importantly, these findings were observed across a range of deucrictibant doses and patient populations, including long-term treatment with deucrictibant for almost three years, with stable measured heart rate, blood pressure, and ECG parameters. We believe these data provide important information on the cardiovascular safety of deucrictibant during its investigation as both a prophylactic and on-demand treatment of bradykinin-mediated angioedema.”
Beyond HAE
A Clinically Validated Kinin Biomarker Assay to Differentiate Bradykinin-Mediated from Mast Cell-Mediated Angioedema was presented by Evangelia Pardali, Ph.D. Pharvaris has developed an assay measuring the levels of bradykinin and other kinin-related peptides in plasma to characterize people with bradykinin-mediated angioedema. In addition to clearly showing bradykinin-forming cascade sensitivity in people with multiple types of HAE and with AAE-C1INH, cold activation caused increased bradykinin levels in samples from individuals with HAE with normal C1 inhibitor of unknown aetiology and angioedema of unknown cause, indication that bradykinin may be involved in the pathogenesis of the angioedema attacks in these individuals. The clinically validated kinin biomarker assay may become a key tool for identifying, studying, and managing bradykinin-mediated diseases, including bradykinin-mediated angioedema.