Deucrictibant

Results from prespecified assessment of End of Progression™ in the RAPIDe-3 Phase 3 study and clinical relevance of this newly-defined endpoint detailed in an oral presentation Evidence on the cardiovascular safety pro deucrictibant in clinical studies to date presented ZUG, Switzerland, June 15, 2026 (GLOBE NEWSWIRE) -- 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 pro 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.” Details of the presentations are outlined below: 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) Capsule was 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 Angioedema was 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 pro 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 pro 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. The presentation and posters are available on the Investors section of the Pharvaris website at: . About Deucrictibant Deucrictibant is a novel, potent, orally bioavailable small-molecule bradykinin B2 receptor antagonist currently in clinical development. Deucrictibant is being investigated for its potential to prevent the occurrence of bradykinin-mediated angioedema attacks and to treat the manifestations of attacks if/when they occur by inhibiting bradykinin signaling through the bradykinin B2 receptor. Pharvaris is developing two formulations of deucrictibant for oral administration: an extended-release tablet to enable sustained absorption and efficacy as prophylactic treatment, and an immediate-release capsule to enable rapid onset of activity for on-demand treatment. Deucrictibant has been granted orphan drug designation for the treatment of bradykinin-mediated angioedema by the U.S. Food and Drug Administration, the European Commission, and Swissmedic. About Pharvaris Pharvaris is a late-stage biopharmaceutical company developing novel, oral bradykinin B2 receptor antagonists to help address unmet needs in bradykinin-mediated conditions, including all types of bradykinin-mediated angioedema. Pharvaris’ aspiration is to offer therapies with injectable-like efficacy™, a well-tolerated profile, and the convenience of oral administration to prevent and treat bradykinin-mediated angioedema attacks. By delivering on this aspiration, Pharvaris aims to provide a new standard of care in bradykinin-mediated angioedema. Pharvaris is preparing marketing authorization applications for deucrictibant immediate-release capsule as an on-demand treatment of HAE attacks, and a global pivotal Phase 3 study of deucrictibant extended-release tablet for the prevention of HAE attacks (CHAPTER-3) is ongoing with topline data anticipated in the third quarter of 2026. In addition, CREAATE is an ongoing Phase 3 study of deucrictibant for the prophylactic and on-demand treatment of AAE-C1INH attacks. For more information, For more information, visit . Forward Looking Statements This press release contains certain forward-looking statements that involve substantial risks and uncertainties. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements relating to our future plans, studies and trials, and any statements containing the words “believe,” “anticipate,” “expect,” “hope,” “estimate,” “may,” “could,” “should,” “would,” “will,” “intend” and similar expressions. These forward-looking statements are based on management’s current expectations, are neither promises nor guarantees, and involve known and unknown risks, uncertainties and other important factors that may cause Pharvaris’ actual results, performance or achievements to be materially different from its expectations expressed or implied by the forward-looking statements. Such risks include but are not limited to the following: uncertainty in the outcome of our interactions with regulatory authorities, including the FDA; the expected timing, progress, or success of our clinical development programs, especially for deucrictibant immediate-release capsules and deucrictibant extended-release tablets, which are in late-stage global clinical trials; our ability to replicate the efficacy and safety demonstrated in the RAPIDe-1, RAPIDe-2, RAPIDe-3, and CHAPTER-1 Phase 2 and Phase 3 studies in ongoing and future nonclinical studies and clinical trials, such as CHAPTER-3, and CREAATE; the timing and outcome of regulatory approvals, including the timing and outcome of our planned submission of an NDA with the FDA in the first half of 2026 for the on-demand treatment of acute attacks of HAE; risks arising from epidemic diseases, which may adversely impact our business, nonclinical studies, and clinical trials; our ability to potentially use deucrictibant for alternative purposes, for example to treat C1-INH deficiency (AAE-C1INH); the value of our ordinary shares; the timing, costs and other limitations involved in obtaining regulatory approval for our product candidates, or any other product candidate that we may develop in the future; our ability to establish commercial capabilities or enter into agreements with third parties to market, sell, and distribute our product candidates; our ability to compete in the pharmaceutical industry, including with respect to existing therapies, emerging potentially competitive therapies and with competitive generic products; our ability to market, commercialize and achieve market acceptance for our product candidates; our ability to produce sufficient amounts of drug product candidates for commercialization; our ability to raise capital when needed and on acceptable terms; regulatory developments in the United States, the European Union and other jurisdictions; our ability to protect our intellectual property and know-how and operate our business without infringing the intellectual property rights or regulatory exclusivity of others; our ability to manage negative consequences from changes in applicable laws and regulations, including tax laws (including the Biosecure Act), our ability to maintain an effective system of internal control over financial reporting; changes and uncertainty in general market conditions; disruptions at the FDA and other agencies; changes and uncertainty in general market, political and economic conditions, including as a result of inflation and geopolitical conflicts; changes in regulations and customs, tariffs and trade barriers; and the other factors described under the headings “Cautionary Statement Regarding Forward-Looking Statements” and “Item 3. Key Information—D. Risk Factors” in our Annual Report on Form 20-F and other periodic filings with the U.S. Securities and Exchange Commission. These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. While Pharvaris may elect to update such forward-looking statements at some point in the future, Pharvaris disclaims any obligation to do so, even if subsequent events cause its views to change. These forward-looking statements should not be relied upon as representing Pharvaris’ views as of any date subsequent to the date of this press release. Contact Maggie Beller Vice President, Head of Corporate and Investor Communications maggie.beller@pharvaris.com