The clinical-stage company Pharvaris B.V. which is focused on the discovery and development of novel oral B2-receptor antagonists for the treatment of HAE, has completed a 66 million USD Series B financing. In addition, the company announces its entry into clinical development with the initiation of a Phase 1 study of its lead compound, PHA121, in healthy volunteers.
“This financing and our outstanding syndicate of investors positions Pharvaris as a clinical leader for the development of oral treatments for patients with HAE,” said Berndt Modig, CEO and co-founder of Pharvaris. “Our experienced team is capitalizing on its deep knowledge of drug development and HAE as we progress in the clinic with PHA121, a new chemical entity targeting the same mechanism as icatibant, a leading therapy for the treatment of HAE attacks. The demands for less invasive routes of drug administration, more convenient dosing regimens, and additional treatment options support the development of an oral therapy to improve the quality of life of patients with HAE.”
The proceeds from the Series B financing will enable Pharvaris to expedite the clinical development of PHA121. The first subjects have been dosed in a Phase 1, randomized, double-blind, placebo-controlled, single-ascending-dose study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of PHA121 in healthy subjects. A multiple-ascending-dose study is anticipated to start in early 2020. In preclinical studies, PHA121 demonstrates oral bioavailability, selective antagonism of the B2 receptor, and potent and rapid activity in bradykinin-mediated disease models.
Jochen Knolle, Ph.D., Chief Scientific Officer and co-founder of Pharvaris, added, “Patients with HAE are eager for effective oral therapies. The development of a novel, oral B2-receptor antagonist could represent a new standard of care for the treatment and prevention of HAE. This first-in-human Phase 1 study is expected to yield important safety and tolerability data. In addition, we expect to demonstrate pharmacodynamics for blocking bradykinin signaling, which will inform the design of subsequent clinical trials.”
Dr Knolle is an inventor of icatibant and, as Chief Scientific Officer and Head of R&D at Jerini AG, was instrumental in the development and first approval of icatibant for treatment of HAE.