deucrictibant extended-release tablet (PHVS719) / Pharvaris, Royalty - LARVOL DELTA

Sustained Therapeutic Exposure with Once-Daily Oral Deucrictibant Extended-Release Tablet for Prophylaxis of Hereditary Angioedema Attacks (ACAAI 2025) - "Methods PHA022121-C020 and PHA022121-C017 were phase 1, open-label, studies in healthy volunteers. Daily deucrictibant XR (40 mg) dosing demonstrated sustained exposure, with mean C24h (predose) at concentrations ∼3-fold higher than EC85. Conclusions A single oral deucrictibant XR tablet resulted in sustained exposure for at least 24 hours, which was not altered by repeat dosing, supporting once-daily dosing of deucrictibant XR tablet in phase 3 trials."

Cardiovascular • Complement-mediated Rare Disorders • Hereditary Angioedema

Long-term prophylactic treatment with deucrictibant for angioedema due to acquired C1-inhibitor deficiency. (PubMed, J Allergy Clin Immunol) - P2 | "Deucrictibant extended-release tablet effectively prevented angioedema attacks in patients with AAE-C1INH, without safety concerns."

Journal • Cardiovascular • Complement-mediated Rare Disorders • Hereditary Angioedema • Rare Diseases

Pharvaris Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business Update (GlobeNewswire) - "CHAPTER-3 is a randomized, double-blind, placebo-controlled Phase 3 study of orally administered deucrictibant extended-release tablet for the prophylaxis against angioedema attacks in adults and adolescents (12 years and older) with HAE. The study aims to enroll approximately 81 participants with HAE and randomize them in a 2:1 ratio to receive deucrictibant extended-release tablet (40 mg/day), which is the intended commercial dosage, or placebo, once daily for 24 weeks. Pharvaris anticipates announcing topline data of CHAPTER-3 in the second half of 2026."

P3 data: top line • Hereditary Angioedema

CHAPTER-4: Long-Term, Open-label Study of Oral Deucrictibant Extended-Release Tablet for Prophylaxis Against Angioedema Attacks in Adolescents and Adults With HAE (clinicaltrials.gov) - P3 | N=130 | Recruiting | Sponsor: Pharvaris Netherlands B.V. | Not yet recruiting ➔ Recruiting

Enrollment open • Cardiovascular • Complement-mediated Rare Disorders • Hereditary Angioedema

CHAPTER-3: Study of Oral Deucrictibant Extended-Release Tablet for Prophylaxis Against Angioedema Attacks in Adolescents and Adults With HAE (clinicaltrials.gov) - P3 | N=81 | Recruiting | Sponsor: Pharvaris Netherlands B.V. | Not yet recruiting ➔ Recruiting

Enrollment open • Cardiovascular • Complement-mediated Rare Disorders • Hereditary Angioedema

CHAPTER-4: Long-Term, Open-label Study of Oral Deucrictibant Extended-Release Tablet for Prophylaxis Against Angioedema Attacks in Adolescents and Adults with HAE (clinicaltrials.gov) - P3 | N=130 | Not yet recruiting | Sponsor: Pharvaris Netherlands B.V.

New P3 trial • Cardiovascular • Complement-mediated Rare Disorders • Hereditary Angioedema

CHAPTER-3: Study of Oral Deucrictibant Extended-Release Tablet for Prophylaxis Against Angioedema Attacks in Adolescents and Adults with HAE (clinicaltrials.gov) - P3 | N=81 | Not yet recruiting | Sponsor: Pharvaris Netherlands B.V.

New P3 trial • Cardiovascular • Complement-mediated Rare Disorders • Hereditary Angioedema

An open-label, multiple dose study to compare the single-dose nand steady-state pharmacokinetics of a 40 mg PHA-022121 nextended-release (XR) tablet administered once daily between nhealthy Japanese, Chinese, and Caucasian volunteers. (ANZCTR) - P1 | N=36 | Completed | Sponsor: Pharvaris Netherlands B.V. | Not yet recruiting ➔ Completed

Trial completion • Cardiovascular • Complement-mediated Rare Disorders • Hereditary Angioedema

An open-label, multiple dose study to compare the single-dose nand steady-state pharmacokinetics of a 40 mg PHA-022121 nextended-release (XR) tablet administered once daily between nhealthy Japanese, Chinese, and Caucasian volunteers. (ANZCTR) - P1 | N=36 | Not yet recruiting | Sponsor: Pharvaris Netherlands B.V.

New P1 trial • Cardiovascular • Complement-mediated Rare Disorders • Hereditary Angioedema

Prophylactic treatment with PHA-022121 in patients with acquired angioedema Onderhoudsbehandeling met PHA-022121 voor patiënten met verworven angio-oedeem (clinicaltrialsregister.eu) - P2 | N=5 | Ongoing | Sponsor: Academisch Medisch Centrum

New P2 trial • Cardiovascular • Hereditary Angioedema • Rheumatology

Pharmacokinetics of PHVS719, extended-release tablet formulation of PHA121, a first-in-class oral human bradykinin B2-receptor antagonist (ACAAI 2022) - "The observed pharmacokinetic of PHVS719 is consistent with the extended-release formulation designed to provide long-term exposure to PHA121. PHVS719 appears to be suitable for once-daily prophylactic dosing in HAE."

PK/PD data • Cardiovascular • Complement-mediated Rare Disorders • Hereditary Angioedema

Development of PHVS719: an Oral Extended-Release Bradykinin B2 Receptor Antagonist to Prevent Hereditary Angioedema Attacks (ACAAI 2022) - "Together these data provide evidence that PHVS719 is optimally suited to serve as a once-daily oral pill. Conclusion The active ingredient PHA121 is under clinical investigation in the form of two therapeutic treatment modalities: PHVS416 softgel capsule providing quick absorption for fast symptom relief and PHVS719 once-daily extended-release tablet providing 24 hours coverage to prevent attacks from occurring."

Cardiovascular • Complement-mediated Rare Disorders • Gastrointestinal Disorder • Hereditary Angioedema