ZUG, Switzerland — 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/.
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