Evidence Supporting Combined Use of Deucrictibant IR with Deucrictibant XR Presented at CIIC Spring 2026 Conference
Rhea-AI Summary
Pharvaris (Nasdaq: PHVS) presented data at CIIC Spring 2026 showing that combined use of a 40 mg deucrictibant XR prophylactic tablet with one or two 20 mg IR capsules for breakthrough attacks is supported by calculated safety margins. A post-hoc CHAPTER-1 analysis showed comparable mean durations for icatibant-treated attacks across placebo and deucrictibant arms, offering initial evidence for the mechanism-on-mechanism approach. Pharvaris highlighted safety and early efficacy signals and said it will further explore combined prophylactic and on-demand deucrictibant use.
AI-generated analysis. Not financial advice.
Positive
- Calculated adequate safety margins for 40 mg XR plus up to two 20 mg IR doses
- Post-hoc CHAPTER-1 analysis shows comparable mean attack durations with icatibant rescue
- Supports a unified prophylaxis + on-demand treatment strategy using the same mechanism
Negative
- Efficacy evidence is from a post-hoc analysis, not a prospective randomized on-demand study
- Safety conclusions rely on modeled exposures and existing clinical/nonclinical data, not new large-scale trials
News Market Reaction – PHVS
On the day this news was published, PHVS gained 1.36%, reflecting a mild positive market reaction.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Market Reality Check
Peers on Argus
Pre-news, PHVS was slightly down while only one peer in momentum (AUPH) appeared, moving down with a -3.61% change and no news; broader biotech peers in the reference list showed mixed, modest gains.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Apr 02 | Earnings and update | Positive | -3.0% | Reported 2025 results, deucrictibant timelines, and year-end cash of €292 million. |
| Mar 20 | Phase 2 publications | Positive | -0.5% | Lancet Haematology Phase 2 data showed significant efficacy and tolerability for prophylaxis and on-demand use. |
| Mar 11 | PRO tools validation | Positive | +6.0% | Peer-reviewed validation of PRO instruments informing Phase 3 RAPIDe-3 endpoint hierarchy. |
| Mar 02 | AAAAI 2026 data | Positive | -1.4% | Presented RAPIDe-3 and CHAPTER-1 data supporting differentiated on-demand and prophylactic profiles. |
| Feb 10 | Upcoming data presentations | Positive | +1.7% | Flagged six AAAAI abstracts including pivotal RAPIDe-3 and CHAPTER-1 extension data. |
Recent history shows multiple positive deucrictibant milestones and publications often met with flat to negative next-day moves, indicating a tendency toward muted or contrarian trading on seemingly favorable news.
Over the past few months, Pharvaris has repeatedly highlighted progress for deucrictibant across prophylaxis and on-demand HAE treatment. An Apr 2 earnings and business update outlined Phase 3 timelines and cash of €292 million. March news included Lancet Haematology Phase 2 efficacy/safety publications, validated PRO tools guiding RAPIDe-3 endpoints, and detailed Phase 3/Phase 2 data presentations at AAAAI 2026. Earlier in Feb, the company flagged pivotal RAPIDe-3 and CHAPTER-3 presentations. Today’s CIIC safety-margin data fits this ongoing narrative of de‑risking the deucrictibant program.
Market Pulse Summary
This announcement adds evidence that combining deucrictibant extended-release for prophylaxis with immediate-release capsules for breakthrough attacks has adequate safety margins, reinforcing Pharvaris’ mechanism-consistent strategy in bradykinin-mediated angioedema. In recent months, the company has reported positive Phase 2 and Phase 3 data, validated outcome measures, and outlined timelines toward topline CHAPTER-3 results in 3Q 2026. Investors monitoring this story may focus on future late-stage readouts, regulatory submissions, and any updates to the deucrictibant development plan.
Key Terms
bradykinin b2 receptor antagonists medical
hereditary angioedema medical
acquired angioedema medical
immediate-release medical
extended-release medical
prophylaxis medical
post-hoc analysis medical
on-demand treatment medical
AI-generated analysis. Not financial advice.
ZUG, Switzerland, April 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), presented data evaluating safety margins of administration of deucrictibant immediate-release (IR) capsule(s) in combination with deucrictibant extended-release (XR) tablet at the Consortium of Independent Immunology Clinics (CIIC) Spring 2026 Conference, which took place from April 17-19, 2026, in Arlington, TX.
“Evaluating Safety Margins of the Use of Deucrictibant Extended-Release Tablet in Combination with Deucrictibant Immediate-Release Capsule” assessed human exposures across the anticipated dosing scenarios 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.
A recently published post-hoc analysis of the prophylaxis CHAPTER-1 study assessed the mean duration of breakthrough attacks, in both placebo and deucrictibant arms, that were treated with a single dose of icatibant, another bradykinin B2 receptor antagonist. The comparable mean total duration of icatibant-treated attacks in the placebo-icatibant and the deucrictibant-icatibant groups provide initial evidence on the efficacy of combining use of a bradykinin B2 receptor antagonist for prophylaxis and on-demand treatment of attacks.
“These safety data, combined with the post-hoc efficacy analyses of mechanism-on-mechanism treatment of breakthrough attacks, provide evidence for the potential of the combined use of deucrictibant as a prophylactic treatment and as an on-demand medication,” said Peng Lu, M.D., Ph.D., Chief Medical Officer of Pharvaris. “Bradykinin-mediated angioedema can be prevented by administering a bradykinin B2 receptor antagonist that exceeds the therapeutic threshold to compete with bradykinin. If the plasma concentration of drug drops below this threshold, a person may be susceptible to a breakthrough attack; rapid exposure to an on-demand treatment using the same mechanism could be a compelling treatment approach in this scenario. We look forward to further exploring this strategy.”
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,” “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
