Patient enrollment for deucrictibant CHAPTER-1 trial completed

Findings will aid study of PHVS719, an extended-release formulation

Patricia Inácio, PhD avatar

by Patricia Inácio, PhD |

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Pharvaris has completed patient enrollment for its proof-of-concept CHAPTER-1 clinical trial that will evaluate the safety and effectiveness of deucrictibant as a prophylactic, or preventive, treatment for adults with hereditary angioedema (HAE).

While the global Phase 2 CHAPTER-1 study (NCT05047185) is still on hold in the U.S., it’s now reached its target goal of about 30 patients.

The participants will be randomly assigned to receive a low (10 mg) or high (20 mg) dose of PHVS416, an immediate-release capsule, or a placebo, twice daily. The trial’s main goal is to assess the number of investigator-confirmed HAE attacks after 12 weeks, or nearly three months.

Top-line data are expected by year’s end, according to Pharvaris. The study’s findings will be used to design a Phase 3 study that will test PHVS719, a once-daily extended-release formulation.

“The completion of enrollment in our Phase 2 CHAPTER-1 prophylactic HAE study, provides momentum as Pharvaris prepares to announce our first in-patient prophylactic clinical data by the end of the year,” Berndt Modig, CEO of Pharvaris, said in a company business update.

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What is deucrictibant?

Deucrictibant is an oral therapy that works by preventing bradykinin, the signaling molecule that drives HAE swelling attacks, from interacting with the receptors it normally binds with to exert its effects.

The U.S. Food and Drug Administration (FDA) placed a clinical hold on the on-demand treatment last year, but this was lifted after interim data was reviewed from a 26-week nonclinical study that’s still underway.

After this, the company was allowed to resume RAPIDe-2 (NCT05396105), a long-term extension study of PHVS416 for the on-demand treatment of HAE. Pharvaris now plans to launch a Phase 3 trial for the on-demand treatment of HAE by the end of the year.

“Resolving the on-demand clinical hold of deucrictibant enables us to proceed with the clinical development of deucrictibant for the on-demand treatment of HAE; we intend to initiate our global Phase 3 on-demand study by the end the year,” Modig said.

Pharvaris has scheduled an end of Phase 2 meeting with the FDA, where it will discuss key elements of the study.

In the meantime, the FDA’s hold on clinical testing of deucrictibant as a prophylactic treatment remains in place pending the completion of the nonclinical study. Pharvaris expects to submit results to the FDA by the end of the year.

“We are focused on resolving the remaining clinical hold on deucrictibant for the long-term prophylactic treatment of HAE in the U.S.,” Modig said.