Data Supporting the Potentially Differentiated Pharvaris Portfolio Presented at ACAAI 2025 Annual Scientific Meeting

Rhea-AI Summary

Pharvaris (Nasdaq: PHVS) presented clinical and biomarker data at ACAAI 2025 highlighting deucrictibant's long-term safety, sustained efficacy, and a validated kinin assay.

Key data: open-label CHAPTER-1 extension showed treatment for up to ~34 months with mean attacks reduced from 2.18 to 0.12 attacks/month and an average 92.4% attack reduction; RAPIDe-2 Part A reported a median time-to-onset of symptom relief of 1.1 hours and median time-to-resolution of 10.6 hours with 89.2% of attacks resolved at 24 hours after a single dose.

The company also reported a clinically validated plasma kinin biomarker assay and reiterated expected pivotal readouts: CHAPTER-3 in H2 2026 and RAPIDe-3 in Q4 2025.

Positive

• Mean attacks down from 2.18 to 0.12 attacks/month
• Average 92.4% attack reduction versus baseline
• Up to ~34 months of open-label safety follow-up
• Median symptom relief in 1.1 hours; 97.8% relief by 12 hours
• 89.2% of attacks resolved at 24 hours with single dose
• Clinically validated kinin biomarker assay for BK-mediated angioedema

Negative

• Key pivotal data pending: CHAPTER-3 readout in H2 2026
• RAPIDe-3 results expected in Q4 2025, creating near-term data dependency
• Open-label extension results reflect non-randomized data and limited N in some subanalyses (e.g., N=30 for moderate/severe attack rate)

Insights

Clinical Development Expert

Long-term and on-demand Phase 2/extension data show durable efficacy and an acceptable safety profile for deucrictibant; pivotal readouts are pending.

Deucrictibant demonstrated a sustained reduction in attack frequency from 2.18 to 0.12 attacks/month in the CHAPTER-1 open-label extension and an average attack reduction of 92.4%, with low rates of moderate/severe attacks (0.06 attacks/month, N=30) and no identified safety signals through ~34 months. On-demand data from RAPIDe-1 and RAPIDe-2 parts report rapid median onset of symptom relief (1.1 hours) and high proportions of attacks resolving by 24 hours (e.g., 89.2% in RAPIDe-2), with single-dose durability in the majority of treated attacks.

The dependent items to watch are clear and discrete: the pivotal prophylaxis readout for CHAPTER-3 in the second half of 2026 and the RAPIDe-3 readout expected in Q4 2025. These data strengthen the clinical package but do not prove Phase 3 success; safety and placebo-controlled efficacy in the upcoming readouts will determine regulatory and commercial relevance over the next 6–18 months.

• Open-label prophylaxis data supporting the long-term safety profile and sustained benefits of deucrictibant, as well as clinical validation data of a kinin biomarker assay were highlighted in two oral presentations
• Final data from participants in the open-label portion of the CHAPTER-1 study provide further evidence of a well-tolerated safety profile for up to approximately 34 months and an average of 92.4% attack reduction from study baseline with deucrictibant treatment
• Six additional posters detail the effectiveness, safety, and health-related quality of life outcomes from various clinical studies with additional evidence on deucrictibant’s potentially differentiated profile in HAE
  
  

ZUG, Switzerland, Nov. 10, 2025 (GLOBE NEWSWIRE) -- Pharvaris (Nasdaq: PHVS), a late-stage biopharmaceutical company developing novel, oral bradykinin B2 receptor antagonists to help address unmet needs of those living with bradykinin-mediated diseases such as hereditary angioedema (HAE) and acquired angioedema due to C1 inhibitor deficiency (AAE-C1INH), summarized the presentations from the 2025 Annual Meeting of the American College of Allergy, Asthma, and Immunology (ACAAI), including data from two oral presentations and six posters, which took place from November 6-10, 2025, in Orlando, Fla.

“We are proud about the recognition of the scientific community of the importance attributed to the late-stage confirmatory clinical data of deucrictibant and the associated biomarker work as oral presentations at the American College for Allergy, Asthma and Immunology annual conference. Beyond the scientific merit we are looking forward to the potential impact deucrictibant could have on the lives of people living with bradykinin-mediated angioedema,” said Berndt Modig, Chief Executive Officer of Pharvaris.

Details of the presentations are outlines below:
Long-Term Prophylaxis
Long-Term Safety and Efficacy of Oral Deucrictibant for Prophylaxis in Hereditary Angioedema: CHAPTER-1 Open-Label Extension, an oral presentation by Marc A. Riedl, M.D., M.S. Data from the final analysis of the open-label extension (OLE) of the two-part Phase 2 clinical study of deucrictibant for the long-term prophylaxis of HAE attacks, CHAPTER-1, provided further evidence about deucrictibant’s well-tolerated profile with no safety signals in the OLE. The attack rate reduction observed by participants within one week of deucrictibant treatment remained low for up to approximately 34 months: the mean attack rate was reduced from a study baseline of 2.18 attacks/month to 0.12 attacks/month in the open-label extension. Importantly, the mean rates of “moderate and severe” attacks and of attacks treated with rescue medication, reduced in the randomized portion of the study, remained low (0.06 attacks/month, N=30) in the open-label portion of the study.

Peng Lu, M.D., Ph.D., Chief Medical Officer of Pharvaris, stated “We are encouraged by the continued positive outcomes in the long-term prophylactic setting that deucrictibant has demonstrated in its clinical studies to date. We appreciate the importance of providing placebo-controlled efficacy and safety data for deucrictibant and therefore look forward to the anticipated Phase 3 data readout of CHAPTER-3 in the second half of 2026. The totality of data, including the placebo-controlled efficacy and safety data from Part 1 of the CHAPTER-1 study, the open-label safety, effectiveness, and health-related quality of life data from Part 2 of the CHAPTER-1 study, and our healthy volunteer and nonclinical PK/PD and safety data, create a compelling data package for deucrictibant in the competitive prophylactic bradykinin-mediated angioedema space, which we hope to confirm with pivotal Phase 3 data.”

Long-Term Prophylactic Treatment with Oral Deucrictibant Improved Disease Control and Health-Related Quality of Life in Hereditary Angioedema: CHAPTER-1, presented by Michael E. Manning, M.D. Data from the final analysis of the open-label extension (OLE) of the two-part Phase 2 clinical study of deucrictibant for the long-term prophylaxis of HAE attacks, CHAPTER-1, showed that treatment with deucrictibant resulted in clinically-meaningful improvements in disease control and health-related quality of life (HRQoL) for up to approximately 34 months.

Sustained Therapeutic Exposure with Once-Daily Oral Deucrictibant Extended-Release Tablet for Prophylaxis of Hereditary Angioedema Attacks, presented by Zhi-Yi Zhang, Ph.D. Continued Phase 1 data supporting the once-daily applicability of deucrictibant extended-release tablet include its single-dose sustained (≥24 hours) therapeutic exposure during repeat dosing and under both fasted and fed conditions.

On-Demand Therapy
Durability of Response to Single Dose Oral Deucrictibant for On-Demand Treatment of Hereditary Angioedema Attacks, presented by Joshua S. Jacobs, M.D. Data from part A of the RAPIDe-2 long-term extension study support deucrictibant’s single-dose durability: ~85% of attacks treated with a single dose of deucrictibant immediate-release (IR) capsule achieved symptom resolution within 24 hours (RAPIDe-2). In a post-hoc analysis of RAPIDe-1 placebo-controlled clinical study and part A of the RAPIDe-2 study, the majority of attacks treated with a single dose of deucrictibant IR that achieved symptom relief and resolution–95-100% (RAPIDe-1) or 98-100% (RAPIDe-2)—had a durable response without symptom reoccurrence.

Dr. Lu continued, “Current unmet needs for on-demand HAE treatments support further investigation into a therapy that could potentially provide a rapid and durable response to treatment through complete resolution with a single capsule, and also address the physical, functional, and emotional burden associated with HAE attack manifestations. RAPIDe-3 data readout, which is expected in the fourth quarter of this year, will provide additional evidence on deucrictibant’s ability to address these unmet needs.”

Long-Term Safety and Efficacy of Oral Deucrictibant for Treatment of Hereditary Angioedema Attacks: RAPIDe-2 Results, presented by John Anderson, M.D. The final results of Part A of the RAPIDe-2 extension study remained consistent with RAPIDe-1, the Phase 2 placebo-controlled clinical trial study of deucrictibant IR capsule for the on-demand treatment of HAE attacks, confirming that deucrictibant remained well-tolerated. Deucrictibant treatment yielded clinically-differentiating efficacy findings, including a median time to onset of symptom relief of 1.1 hours, with 97.8% of attacks achieving this milestone in 12 hours, and a median time to complete resolution of 10.6 hours, with 89.2% of the attacks resolving at 24 hours being treated with a single dose and most of them not experiencing symptom reoccurrence.

Outcomes of Deucrictibant-Treated Upper Airway and Laryngeal Hereditary Angioedema Attacks: RAPIDe-2 Part A Results, presented by John Anderson, M.D. Consistency was observed between outcomes after deucrictibant treatment of upper airway HAE attacks, including laryngeal attacks, and HAE attacks occurring in other locations in the final results from Part A of the RAPIDe-2 long-term extension study. When treating upper airway attacks, deucrictibant was well-tolerated and resulted in a median time to onset of symptom relief of 1.4 hours and a median time to complete symptom resolution of 8.9 hours. Additionally, 92.9% of the upper-airway attacks treated required only a single dose of deucrictibant.

Deucrictibant vs. Standard of Care in Hereditary Angioedema: A Propensity Score-Matched Analysis, presented by Mark D. Scarupa, M.D. Following a propensity score matching analysis of deucrictibant IR capsule-treated attacks from the RAPIDe-2 Phase 2/3 long-term extension study and a cohort of standard-of-care-treated attacks in a mixed-methods, real-world observational study, deucrictibant-treated attacks demonstrated more favorable outcomes across most efficacy endpoints.

Expansion Beyond HAE
Clinical Validation of a Kinin Biomarker Assay to Characterize Bradykinin-Mediated Angioedema, an oral presentation by Evangelia Pardali, Ph.D. Pharvaris has established an assay that can measure the levels of bradykinin and other kinin peptides in plasma to characterize people with bradykinin-mediated angioedema. The clinically validated kinin biomarker assay may become a key tool for identifying, studying, and managing BK-mediated pathologies, including angioedema.

Anne Lesage, Ph.D., Chief Early Development Officer of Pharvaris, stated, “Through the reliable and reproducible measurement of levels of bradykinin and its breakdown peptides in plasma, we can assess bradykinin-forming cascade sensitivity, thereby potentially identifying further applications for deucrictibant as a bradykinin B2 receptor antagonist.”

The posters and presentation slides are available on the Investors section of the Pharvaris website at: https://ir.pharvaris.com/news-events/publications

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, Swissmedic, and the European Commission.

About Pharvaris
Pharvaris is a late-stage biopharmaceutical company developing novel, oral bradykinin B2 receptor antagonists to potentially address all types of bradykinin-mediated angioedema. Pharvaris intends to provide injectable-like efficacy™ and placebo-like tolerability with the convenience of oral therapies to prevent and treat bradykinin-mediated angioedema attacks. With positive data in both Phase 2 prophylaxis and on-demand studies in HAE, Pharvaris is currently evaluating the efficacy and safety of deucrictibant in a pivotal Phase 3 study for the prevention of HAE attacks (CHAPTER-3) and a pivotal Phase 3 study for the on-demand treatment of HAE attacks (RAPIDe-3). For more information, visit https://pharvaris.com/.

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,” “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, and CHAPTER-1 Phase 2 and Phase 3 studies in ongoing and future nonclinical studies and clinical trials, such as RAPIDe-3, CHAPTER-3, and CREAATE; 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 outcome and timing of regulatory approvals; 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
Executive Director, Head of Corporate and Investor Communications
maggie.beller@pharvaris.com

FAQ

What did Pharvaris (PHVS) announce about deucrictibant at ACAAI 2025?

Pharvaris presented long-term and on-demand clinical data showing sustained safety up to ~34 months, an average 92.4% attack reduction, and a validated kinin biomarker assay.

How much did deucrictibant reduce HAE attacks in CHAPTER-1 OLE (PHVS)?

Mean attack rate fell from 2.18 to 0.12 attacks/month, an average 92.4% reduction versus baseline.

What are the on-demand efficacy timelines for deucrictibant (PHVS)?

RAPIDe studies reported median onset of symptom relief of 1.1 hours, median resolution of 10.6 hours, and 89.2% resolved at 24 hours.

Are there upcoming pivotal readouts for PHVS deucrictibant?

Yes; the company expects CHAPTER-3 Phase 3 readout in H2 2026 and RAPIDe-3 results in Q4 2025.

What is the kinin biomarker assay announced by Pharvaris (PHVS)?

A clinically validated plasma assay that measures bradykinin and breakdown peptides to characterize bradykinin-mediated angioedema.

How durable is a single dose of deucrictibant for HAE attacks (PHVS)?

Data show about 85% of attacks in RAPIDe-2 achieved symptom resolution within 24 hours after a single dose, with most showing no symptom recurrence.