Pharvaris Expanding PHVS416 Trial to US, Launching 2nd Study

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by Marisa Wexler MS |

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PHVS416 trial expanding to US/angioedemanews.com/Pharvaris-sponsored Phase 2 trial

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RAPIDe-1, a Phase 2 clinical trial testing Pharvaris’ investigational oral therapy PHVS416 as an on-demand treatment for swelling attacks in people with hereditary angioedema (HAE), will expand its enrollment this year to include patients in the U.S.

“We are encouraged by positive feedback from clinical sites and look forward to expanding [RAPIDe-1] to provide the opportunity for U.S. patients to participate,” Berndt Modig, co-founder and CEO of Pharvaris, said in a press release.

The company said it also plans to launch a second Phase 2 trial of the oral therapy later this year. That trial, CHAPTER-1, will test PHVS416 as a prophylactic, or preventive, treatment for HAE.

Topline data from both trials are expected to be reported in 2022, Modig said.

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Both enrollment and dosing of patients in RAPIDe-1 (NCT04618211) began earlier this year. Participants currently are being recruited in Canada, Israel, and several European countries, including Spain, France, and Czechia. The study aims to enroll around 54 adults with HAE type 1 or 2. No information is available yet on U.S. recruiting sites.

Sponsored by Pharvaris, the RAPIDe-1 trial is being conducted in two phases. In the first, participants who are not experiencing a swelling attack will be given a single dose of PHVS416 at a study center to assess the safety and pharmacokinetics of the experimental therapy. Pharmacokinetics is the study of how a medication is taken up, processed, and then eliminated from the body

In the second phase, patients will be given either PHVS416 or a placebo to treat three swelling attacks at home.

While RAPIDe-1 is focused on PHVS416 as an on-demand treatment, Chapter-1 will test the same therapy for preventive use. Authorization for this PHVS416 trial was granted back in April by the U.S. Food and Drug Administration. While no start date has yet been announced, Pharvaris said it will launch in 2021.

“We look forward to initiating the prophylactic study of PHVS416 as the first step in our plans to bring forward a new option for oral prophylaxis of HAE,” Modig said in a separate press release.

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Swelling in HAE is caused by the excessive levels of a signaling molecule called bradykinin, which triggers swelling episodes by binding to specific protein receptors found in body tissues. PHVS416 is a soft gel capsule formulation of PHA121, a small molecule that is able to bind and block one of these protein receptors, called bradykinin B2 receptor.

In addition to PHVS416, Pharvaris is developing an extended-release tablet formulation of PHA121 called PHVS719, also as a potential preventive treatment for HAE. The company is planning to initiate a Phase 1 clinical trial to test PHVS719’s pharmacokinetics by the end of this year.

Pharvaris recently presented Phase 1 clinical trial data showing that multiple doses of PHA121 were well-tolerated and capable of rapidly reaching therapeutic levels in healthy volunteers.

According to Modig, these data “continue to demonstrate the compelling [pharmacokinetic/pharmacodynamic] and safety profiles of PHA121, which is the active ingredient in PHVS416 and PHVS719.” Of note, pharmacodynamics studies the effects a medication has on the body.

Notably, both PHVS416 and PHVS719 are designed to be oral therapies, which sets them apart from most other medications used to treat HAE, which are administered through injections.

“Patients are seeking oral alternatives to existing therapies, and we are eager to continue our evaluation of products based on PHA121 for both on-demand and prophylactic settings,” Modig said.