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Pharvaris to present PHVS416, PHVS719 clinical data
The Fly

Pharvaris to present PHVS416, PHVS719 clinical data

Pharvaris announced it will be presenting two in-person "ePoster – Meet the Author" presentations at the American College of Allergy, Asthma & Immunology, ACAAI, Annual Scientific Meeting 2022, being held from November 10-14, 2022, in Louisville, Ky. Title: Development of PHVS719: an Oral Extended-Release Bradykinin B2 Receptor Antagonist to Prevent Hereditary Angioedema Attacks. Pharmacokinetic properties of PHA121 were evaluated to support the intended therapeutic use of PHVS719 for the prophylactic treatment of HAE attacks using preclinical and clinical experimental models. In rodents, plasma concentrations following oral and intracolonic administrations of PHA121 were comparable, providing evidence that PHA121 can be systemically absorbed by colonic mucosa. In humans, high oral bioavailability and low fecal excretion further indicate almost-complete absorption in the gastrointestinal tract. Title: Pharmacokinetics of PHVS719, extended-release tablet formulation of PHA121, a first-in-class oral human bradykinin B2-receptor antagonist. In the Phase 1 pharmacokinetic study of PHVS719, 10 healthy subjects received, in a randomized order, two different doses of PHVS719 extended-release tablets, in fasting and in fed conditions, and one dose of PHVS416 20 mg in fasting conditions. Measurement of time-to-reach-therapeutic-exposure-levels for PHA121 above the EC85 of 13.8 ng/mL showed that after administration of XR1 and XR2, therapeutic plasma concentrations were achieved within approximately two hours. Food intake did not have significant effects on the time to reach therapeutic exposure of PHA121 nor on the time at which concentrations remained at therapeutic levels. Administration of both PHVS719 and of PHVS416 were well tolerated. No severe nor serious treatment-emergent adverse events were reported, with no specific safety pattern or trend in number or type of events.

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