Pharvaris Presents Clinical and Real-World Data at the ACAAI 2026 Annual Scientific Meeting

Rhea-AI Summary

Pharvaris (Nasdaq: PHVS) reported Phase 3 CHAPTER-3 results showing an 83% reduction in hereditary angioedema attack rates versus placebo. The trial randomized 85 participants to once-daily deucrictibant extended-release 40 mg or placebo for 24 weeks and met its primary and all secondary efficacy endpoints with statistical significance. A post hoc analysis found an 87% reduction in participants with HAE Type 1 or 2; 45% of treated participants were attack-free throughout treatment.

Deucrictibant was generally well tolerated, with no treatment-related serious adverse events in CHAPTER-3. Additional ACAAI presentations cover attack reductions lasting up to approximately 34 months in an open-label extension and faster cessation of attack worsening with immediate-release treatment versus placebo. Modeling supports potential combined use of both formulations, subject to regulatory approval of each.

18 points · 1 major

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0 major · 1 point

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Positive

• Major pointCHAPTER-3 met its primary and all secondary efficacy endpoints with statistical significance.
• Moderate pointMedian time until attacks stopped worsening was 17.47 minutes with immediate-release deucrictibant versus more than 3.5 hours with placebo.
• Minor pointAttack rates fell 83% versus placebo across all HAE types in CHAPTER-3 (p<0.0001).
• Minor pointHAE Type 1 or 2 attack rates fell 87% versus placebo in a post hoc analysis.
• Minor pointAttack-rate reductions appeared within the first week and persisted throughout CHAPTER-3.

13 minor points

• Minor pointAttacks requiring on-demand medication fell 83% versus placebo in CHAPTER-3.
• Minor pointModerate-to-severe attacks fell 77% versus placebo in CHAPTER-3.
• Minor point98%, 96% and 65% achieved at least 50%, 70% and 90% attack reductions versus pretreatment, respectively.
• Minor point45% of deucrictibant-treated participants remained attack-free throughout CHAPTER-3's 24-week treatment period.
• Minor pointAngioedema quality-of-life scores improved significantly versus placebo, including total score and all domains.
• Minor pointCHAPTER-3 tolerability was generally favorable, with no treatment-related serious adverse events reported.
• Minor pointCHAPTER-1 extension attack rates fell 92.4% on average versus randomized-trial baseline, remaining low up to approximately 34 months.
• Minor pointAt least 90% attack reductions occurred in most extension participants at follow-up timepoints through week 132.
• Minor pointCHAPTER-1 extension reported no treatment-related severe or serious treatment-emergent adverse events, or adverse-event-driven discontinuations, withdrawals or deaths.
• Minor pointMore than 95% of treated attacks achieving predefined relief and resolution endpoints maintained responses throughout respective assessment periods.
• Minor pointMore than 80% of attacks achieving those endpoints with sustained responses did so with a single capsule.
• Minor pointModeled combined-formulation exposure remained below the nonclinical no-observed-adverse-effect level and highest exposure previously explored in humans.
• Minor pointIntegrated cardiovascular analysis showed no evidence of QTc prolongation or increased cardiovascular-event risks across clinical studies.

Negative

• Minor pointPotential combined use of extended-release and immediate-release deucrictibant remains subject to regulatory approval of each formulation.

Key Figures

Attack-rate reduction: 83% Attack-rate reduction: 87% Attack-free participants: 45% +5 more

Attack-rate reduction

83%

Phase 3 CHAPTER-3, all HAE types, versus placebo

Attack-rate reduction

87%

Phase 3 CHAPTER-3 post hoc analysis, HAE Type 1 or 2, versus placebo

Attack-free participants

45%

During the entire 24-week Phase 3 CHAPTER-3 treatment period

CHAPTER-3 study size and duration

85 participants; 24 weeks

Global Phase 3 study; participants randomized 2:1 to 40 mg XR or placebo

Attack-rate reduction

92.4%

Phase 2 CHAPTER-1 open-label extension, from randomized controlled trial baseline

Median time to end of progression

17.47 minutes vs. more than 3.5 hours

Phase 3 RAPIDe-3, deucrictibant IR versus placebo

Responses sustained

More than 95%

Deucrictibant-treated attacks achieving predefined relief and resolution endpoints

Median HAE-related costs per patient per year

$43,271 to $240,064

U.S. closed-claims analysis, baseline to follow-up

Historical Context

2 past events · Latest: Sep 08

2 events

1. Sep 08

   CHAPTER-3 topline

   24h Move

   +7.3%

   CHAPTER-3 reported 83% lower monthly attack rate versus placebo across HAE types.

2. Sep 03

   CHAPTER-1 extension

   24h Move

   +1.4%

   CHAPTER-1 extension reported mean monthly attacks falling from 2.18 to 0.12.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

hae, open-label extension, population pharmacokinetic modeling, qtc prolongation

4 terms

hae medical

"those living with bradykinin-mediated diseases such as hereditary angioedema (HAE)"

Hereditary angioedema (HAE) is a rare genetic disorder that causes sudden, severe swelling in tissues such as the face, throat, abdomen and limbs due to abnormal control of blood vessel leakage. It matters to investors because HAE treatments, which can be life‑saving and are often taken long‑term, represent a specialized drug market with high per‑patient revenue and regulatory, pricing and reimbursement risks similar to other rare‑disease therapies.

open-label extension medical

"Final Results From the CHAPTER-1 Open-Label Extension"

An open-label extension is a continuation of a clinical trial where all participants and researchers know which treatment is being given, often after an initial blinded phase. It allows further study of a drug's long-term safety and effectiveness. For investors, it can indicate ongoing interest and confidence in a product's potential, influencing perceptions of its future value.

population pharmacokinetic modeling technical

"Population pharmacokinetic modeling and simulation analysis demonstrated"

Population pharmacokinetic modeling is a statistical method that describes how a medicine is absorbed, distributed, broken down and removed from the body across many people, capturing typical behavior and differences among subgroups. Think of it as a traffic map showing how various types of drivers (age, weight, kidney function) affect travel time; for investors it informs dosing decisions, safety profiles, regulatory approval risk and potential market size by predicting how broadly and safely a therapy can be used.

qtc prolongation medical

"no evidence of QTc prolongation or increased risks of CV events"

QTc prolongation is a lengthening of the heart’s electrical “reset” time between beats, measured on an electrocardiogram and adjusted for heart rate. It matters to investors because prolonged QTc can signal a drug or device safety risk that may lead to regulatory warnings, clinical trial delays, label restrictions, market withdrawals, or higher liability costs—similar to a car whose brakes take longer to reset, increasing the chance of a dangerous failure.

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• Phase 3 CHAPTER-3 results to be presented in the Distinguished Industry and Late-breaking Oral Abstracts sessions on Saturday, November 14, from 4:30-6:00 p.m. MST
• CHAPTER-3 met the primary and all secondary efficacy endpoints with statistical significance, confirming deucrictibant XR’s potential for the prevention of HAE attacks
• Deucrictibant XR reduced the monthly attack rate by 83% in all HAE types and 87% in HAE Type 1 or 2 vs. placebo and was generally well tolerated
  

ZUG, Switzerland, Nov. 12, 2026 (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 oral and poster presentations at the American College of Allergy, Asthma & Immunology (ACAAI) 2026 Annual Scientific Meeting, taking place November 12-16, 2026, in Phoenix, Arizona. The presentations include late-breaking results from the Phase 3 CHAPTER-3 study evaluating investigational oral deucrictibant extended-release (XR) tablet for prophylaxis of HAE attacks to be presented in the Distinguished Industry and Late-breaking Oral Abstracts sessions on Saturday, November 14 from 4:30 – 6:00 p.m. MST, as well as final long-term results from the prophylaxis Phase 2 open-label extension, additional analyses of the pivotal Phase 3 on-demand treatment study, clinical pharmacology data supporting the potential combined use of the XR and immediate-release (IR) formulations, a comprehensive assessment of deucrictibant’s cardiovascular safety across the development program, and the real-world economic burden of HAE.

“This first opportunity to share CHAPTER-3 primary data with the medical community in the setting of a large scientific conference represents an important milestone in deucrictibant’s clinical development, with once-daily oral deucrictibant XR demonstrating reductions in the HAE attack rate in the range of those observed with injectable long-term prophylactic therapies, and nearly half of participants remaining attack-free over the entire 24-week treatment period,” said Peng Lu, M.D., Ph.D., President of Pharvaris. “When considered alongside the wealth of data being presented at ACAAI across our on-demand and prophylaxis clinical programs, as well as data exploring the economic burden of HAE to the healthcare system, these findings strengthen our belief in deucrictibant’s potential to address unmet needs and to change how people living with bradykinin-mediated angioedema manage their disease. Our ambition is to provide the community with effective and well-tolerated oral treatment options designed with the objective of addressing patients’ needs, whether to prevent attacks or to treat them when they occur, and ultimately to lessen the impact of this unpredictable disease on everyday life and healthcare systems.”

Details of the presentations are outlined below:

Long-Term Prophylaxis Therapy
Oral Deucrictibant Extended-Release Tablet for Prophylaxis of Hereditary Angioedema Attacks: The Phase 3 CHAPTER-3 Trial will be presented as a late-breaking oral presentation by Marc A. Riedl, M.D., M.S. In the global Phase 3 CHAPTER-3 study (NCT06669754), 85 participants with HAE, including HAE with normal C1 inhibitor, were randomized 2:1 to once-daily deucrictibant XR 40 mg or placebo for 24 weeks. Deucrictibant XR reduced the HAE attack rate by 83% versus placebo (p<0.0001) across all HAE types. In a post hoc analysis in participants with HAE Type 1 or 2, the attack rate was 87% lower in the group treated with deucrictibant XR compared to the group receiving placebo. Reductions in attack rate were observed within the first week of treatment and sustained throughout the study. Monthly rates of attacks treated with on-demand medication and of moderate-to-severe attacks were reduced by 83% and 77%, respectively, versus placebo. In addition, 98%, 96% and 65% of deucrictibant-treated participants achieved at least 50%, 70% and 90% reductions in attack rate compared to pre-treatment, respectively, and 45% were attack-free during the entire 24-week treatment period. Deucrictibant XR also resulted in significantly greater improvements in AE-QoL total score and all domain scores versus placebo. Deucrictibant XR was generally well tolerated with no treatment-related serious adverse events reported; no treatment-related cardiovascular adverse events were reported, and there were no treatment-related clinically significant abnormalities in heart rate, blood pressure or ECG findings.

Oral Deucrictibant for Prophylaxis of Hereditary Angioedema Attacks: Final Results From the CHAPTER-1 Open-Label Extension will be presented by Michael E. Manning, M.D. Final results from the Phase 2 CHAPTER-1 open-label extension (OLE; NCT05047185) show that reductions in HAE attack rate were observed within the first week of deucrictibant treatment and remained low for up to approximately 34 months. Participants experienced an average of 92.4% reduction in attack rate from the randomized controlled trial baseline, with an overall mean monthly attack rate of 0.12 during the OLE compared with 2.18 at baseline. At follow-up timepoints through week 132, the majority of participants achieved at least a 90% reduction in attack rate. Deucrictibant was well tolerated, with no treatment-related severe or serious treatment-emergent adverse events and no adverse events leading to study drug discontinuation, study withdrawal, or death.

On-Demand Therapy
Early and Sustained Effects of Deucrictibant Immediate-Release Capsule for On-Demand Treatment of Hereditary Angioedema Attacks will be presented by John Anderson, M.D. Phase 3 RAPIDe-3 analyses of 88 participants with paired treated attacks assessing the rapidity and durability of the response to on-demand treatment of attacks demonstrated that deucrictibant IR 20 mg achieved end of progression¹ (EoP), the earliest evidence of treatment effect when attack manifestations stop worsening and begin evolving toward relief and resolution, substantially earlier than placebo, with a median time to EoP of 17.47 minutes versus more than 3.5 hours. More than 95% of deucrictibant-treated attacks that achieved the predefined clinical endpoints of relief and resolution then maintained the response throughout the respective assessment periods. More than 80% of attacks that achieved these endpoints with a sustained response did so with a single capsule.

Combination Treatment
Evaluation of Safety Margins and Response to Deucrictibant Immediate-Release Capsule Combined with Deucrictibant Extended-Release Tablet will be presented by Anne Lesage, Ph.D. The analyses evaluated the safety margins for potential combined use of deucrictibant XR for prophylaxis and deucrictibant IR for on-demand treatment of an attack occurring during prophylactic treatment. Deucrictibant XR 40 mg is formulated to maintain plasma concentrations above the effective therapeutic concentration (EC₈₅) for more than 24 hours, while deucrictibant IR is formulated to rapidly exceed EC₈₅. Population pharmacokinetic modeling and simulation analysis demonstrated that estimated systemic exposure when XR was combined with one or two IR capsules remained below both the nonclinical no observed adverse-effect level and the highest exposure previously explored in humans. These findings support the potential combined use of the two formulations to address both the prevention and treatment of attacks in people living with bradykinin-mediated angioedema, subject to regulatory approval of each formulation.

Cardiovascular Safety
Clinical Cardiovascular Safety Evaluation of Oral Deucrictibant will be presented by Anne Lesage, Ph.D. An integrated analysis of cardiovascular (CV) safety data across completed and ongoing Phase 1, 2, and 3 clinical studies of deucrictibant for on-demand as well as for prophylactic treatment showed no evidence of QTc prolongation or increased risks of CV events with deucrictibant. As of June 10, 2026, more than 740 unique participants were estimated to have been exposed to deucrictibant across 25 Pharvaris-sponsored clinical studies. A concentration-QTc analysis found no evidence of QTc prolongation, including at the highest estimated clinical exposure. In the Phase 3 CHAPTER-3 study of deucrictibant XR for long-term prophylaxis, over 24 weeks of treatment, no treatment-related cardiac or vascular disorder adverse events and no treatment-related clinically significant abnormalities in heart rate, blood pressure, or ECG findings were reported. These findings were consistent with longer-term observations from CHAPTER-1, in which participants received deucrictibant for up to approximately 34 months.

Real-World Evidence
Economic Burden and Treatment Patterns Among Individuals with Hereditary Angioedema: a U.S. Closed Claims Analysis will be presented by Raffi Tachdjian, M.D., MPH. A retrospective analysis of U.S. closed claims data from 952 adolescents and adults with claims-identified HAE found substantial healthcare resource utilization and treatment burden despite the use of available HAE therapies. During a median follow-up of 2.4 years, 20.3% of individuals had at least one HAE-related inpatient stay and 25.4% had at least one HAE-related emergency room visit. Median HAE-related medical and pharmacy costs per patient per year increased from $43,271 at baseline to $240,064 during follow-up. The findings demonstrate the cost of suboptimal disease management among people with HAE in U.S., highlighting the opportunity for innovative treatments to further improve disease control and potentially decrease the overall economic burden of HAE.

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

_{¹ The term End of Progression is a registered trademark of Pharvaris GmbH.}

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. 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” 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; the outcome of regulatory approvals, including the outcome of our NDA and MAA for the on-demand treatment of acute attacks of HAE; our ability to replicate the efficacy and safety demonstrated in the RAPIDe-1, RAPIDe-2, RAPIDe-3, CHAPTER-1, and CHAPTER-3 Phase 2 and Phase 3 studies in ongoing and future nonclinical studies and clinical trials, such as 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 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 

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did Pharvaris PHVS report from the Phase 3 CHAPTER-3 trial?

Deucrictibant extended-release reduced HAE attack rates by 83% versus placebo across all HAE types, and CHAPTER-3 met its primary and all secondary efficacy endpoints with statistical significance. The trial randomized 85 participants to once-daily 40 mg or placebo for 24 weeks; 45% of treated participants remained attack-free throughout treatment.

How quickly did Pharvaris deucrictibant immediate-release stop HAE attacks from worsening?

Median time until attack manifestations stopped worsening was 17.47 minutes with deucrictibant immediate-release 20 mg versus more than 3.5 hours with placebo. The Phase 3 RAPIDe-3 analysis included 88 participants with paired treated attacks. This endpoint measures the earliest treatment effect, rather than complete attack resolution.

What were the final long-term attack rates in Pharvaris CHAPTER-1 extension?

The overall mean monthly attack rate was 0.12 during the open-label extension, compared with 2.18 at the randomized controlled trial baseline. Participants experienced an average 92.4% reduction from that baseline, and attack rates remained low for up to approximately 34 months.

How much clinical exposure supported Pharvaris deucrictibant cardiovascular safety analysis?

As of June 10, 2026, more than 740 unique participants were estimated to have received deucrictibant across 25 Pharvaris-sponsored clinical studies. The integrated analysis covered completed and ongoing Phase 1, 2 and 3 studies and found no evidence of QTc prolongation, including at the highest estimated clinical exposure.