Evidence of Efficacy and Safety of Deucrictibant for Prophylaxis and On-Demand Treatment of Hereditary Angioedema Attacks Published Back-to-Back in The Lancet Haematology
MWN-AI** Summary
Pharvaris, a biopharmaceutical company focused on developing oral bradykinin B2 receptor antagonists, recently published two significant articles in The Lancet Haematology detailing the efficacy and safety of deucrictibant for managing hereditary angioedema (HAE). The studies, CHAPTER-1 and RAPIDe-1, provided compelling evidence for deucrictibant's role in both prophylactic and on-demand treatment of HAE.
CHAPTER-1 was a double-blind, placebo-controlled Phase 2 trial assessing deucrictibant as a preventative treatment. The results indicated a statistically significant reduction in HAE attack occurrences along with notable improvements in disease management and quality of life. Similarly, RAPIDe-1 evaluated the immediate-release capsule of deucrictibant for acute HAE attacks. Participants experienced a significant decrease in attack severity, with faster symptom relief and resolution.
Dr. Marc A. Riedl, an investigator in these studies, emphasized the potential of bradykinin B2 receptor antagonism to manage HAE effectively. With the flexibility of both immediate-release and extended-release formulations, deucrictibant is positioned as a unique oral therapy, aiming to enhance the treatment landscape for HAE patients.
Pharvaris is preparing for regulatory applications in 2026, and ongoing studies like CHAPTER-3 will further evaluate the extended-release formulation. Previous standard care options have set a benchmark, yet these findings position deucrictibant as a promising alternative, potentially establishing a new standard in bradykinin-mediated angioedema care.
This body of research not only strengthens the clinical understanding of bradykinin-mediated diseases but also informs future clinical practice for optimal patient management. With the anticipated data from ongoing trials, the hope is to expand therapeutic options and improve outcomes for those affected by HAE.
MWN-AI** Analysis
Based on the recent Phase 2 clinical study results surrounding deucrictibant for hereditary angioedema (HAE) published in *The Lancet Haematology*, investors should closely monitor Pharvaris (Nasdaq: PHVS). The data from the CHAPTER-1 and RAPIDe-1 trials suggest that deucrictibant could redefine treatment protocols for HAE, a condition with substantial unmet needs. The dual approach—both prophylactic and on-demand treatment—could position deucrictibant as a unique offering in a niche market.
Significantly, the statistically significant results showing a reduction in attack frequency and severity speak volumes about the drug's efficacy and safety. Given that current treatments are often injectable, the oral formulation may enhance patient adherence and expand the addressable market. This is especially crucial as the bid for regulatory approval approaches, which is a key inflection point for the stock.
The back-to-back publication in a reputable journal provides validation from the scientific community, potentially enhancing investor confidence. If Pharvaris successfully navigates the next stages, including the Phase 3 trials and subsequent marketing authorization, it stands poised to capture market share against competitors relying on older, more invasive treatments.
As such, strategic investment into Pharvaris could be worthwhile, particularly ahead of the anticipated topline data from the ongoing Phase 3 clinical studies scheduled for the latter half of 2026. However, caution is warranted—investors should remain vigilant regarding any regulatory hurdles or unforeseen issues that may arise, given the inherent uncertainties in biotech ventures. In summary, Pharvaris presents a compelling investment opportunity contingent upon successful clinical validation and regulatory approval.
**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.
- Results from Phase 2 clinical studies, CHAPTER-1 and RAPIDe-1, provide evidence of viability of bradykinin B2 receptor antagonism in management of HAE
ZUG, Switzerland, March 20, 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), today announced that two articles have been published back-to-back in the same issue of The Lancet Haematology. The articles detail data from the two randomized Phase 2 studies, CHAPTER-1 and RAPIDe-1, evaluating the efficacy and safety of deucrictibant, a potent, orally bioavailable small-molecule bradykinin B2 receptor antagonist, in development for the prophylaxis and on-demand treatment of HAE attacks, respectively.
“Since HAE is a bradykinin-mediated disease, regulation of bradykinin signaling through B2 receptor antagonism could both prevent HAE attacks and manage angioedema symptoms when they occur,” said Marc A. Riedl, M.D., M.S., Professor of Medicine, Clinical Director of the U.S. Hereditary Angioedema Association (HAEA) Angioedema Center at the University of California San Diego (UCSD), and investigator in both studies. “The statistically significant, placebo-controlled data from these two distinct clinical studies provide important evidence that deucrictibant, a bradykinin B2 receptor antagonist, may offer a viable option for both prophylactic and acute treatment of HAE attacks. Based on these results, deucrictibant is emerging as a potentially unique oral therapy for HAE, providing on-demand and preventative treatment effects through the availability of both the immediate-release capsule and extended-release tablet. This complementary approach may further improve HAE management for patients and prescribers alike.”
CHAPTER-1 Study Results
CHAPTER-1, a double-blind, placebo-controlled Phase 2 proof-of-concept study of deucrictibant for the prophylactic treatment of HAE attacks, demonstrated statistically significant reduction in the occurrence of attacks and clinically meaningful improvements in disease control and health-related quality of life. Deucrictibant was well tolerated at both doses tested.
RAPIDe-1 Study Results
RAPIDe-1, a double-blind, placebo-controlled Phase 2 study of deucrictibant immediate-release capsule for the on-demand treatment of HAE attacks, demonstrated a statistically significant reduction in severity of attack manifestations, as well as a reduced time to symptom relief and resolution. Deucrictibant was well tolerated at all doses tested.
Peng Lu, M.D., Ph.D., Chief Medical Officer of Pharvaris, stated, “icatibant use has established bradykinin B2 receptor antagonism as the standard-of-care approach for on-demand treatment of HAE attacks. The RAPIDe-1 data are the first-ever clinical study data supporting deucrictibant as an oral on-demand therapy, and the CHAPTER-1 data are the first-ever clinical study data supporting bradykinin B2 receptor antagonism as an effective approach for prophylaxis of HAE attacks. Upon regulatory approval for both indications, deucrictibant could offer an end-to-end portfolio of options for bradykinin-mediated angioedema care. The two articles, published concurrently in The Lancet Haematology, add to the scientific evidence to further advance understanding of bradykinin-mediated angioedema and eventually inform clinical decisions about management in real-world clinical practice.”
Topline data from CHAPTER-3 (NCT06669754), an ongoing Phase 3 clinical study evaluating deucrictibant extended-release tablet for the prophylactic treatment of HAE attacks, is anticipated in the third quarter of 2026. Topline data from RAPIDe-3 (NCT06343779), a pivotal, placebo-controlled Phase 3 clinical study evaluating deucrictibant immediate-release capsule for the on-demand treatment of HAE attacks, demonstrated that treatment with deucrictibant resulted in faster symptom relief and complete symptom resolution of HAE attacks and in most attacks being treated with a single capsule. These confirmatory data of deucrictibant’s potential as an oral on-demand treatment were presented at the American Academy of Allergy, Asthma & Immunology (AAAAI) 2026 Annual Meeting.
The full articles can be found here:
- Oral deucrictibant for prophylaxis of hereditary angioedema attacks (CHAPTER-1): primary analysis of a randomised, double-blind, placebo-controlled, phase 2 trial
- Oral deucrictibant for on-demand treatment of hereditary angioedema attacks (RAPIDe-1): a randomised, double-blind, placebo-controlled, phase 2 trial
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, 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, 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 BellerExecutive Director, Head of Corporate and Investor Communicationsmaggie.beller@pharvaris.com
FAQ**
How do the results from the Phase 2 studies CHAPTER-1 and RAPIDe-1 provide evidence for the viability of bradykinin B2 receptor antagonism in managing HAE, as indicated in the announcement by Pharvaris N.V. PHVS?
What specific statistically significant outcomes were reported in the Phase 2 studies by Pharvaris N.V. PHVS for deucrictibant's efficacy in both prophylactic and on-demand treatment of HAE?
In terms of safety and tolerability, how did the Phase 2 study results for deucrictibant compare to existing treatments available for HAE, according to findings from Pharvaris N.V. PHVS?
How might the oral administration forms of deucrictibant, as discussed by Pharvaris N.V. PHVS, impact patient compliance and overall management of HAE attacks in clinical practice?
**MWN-AI FAQ is based on asking OpenAI questions about Pharvaris N.V. (NASDAQ: PHVS).
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