Pharvaris N.V. has announced two poster presentations that revealed positive results from the RAPID-e1 phase 2 study of PHVS416 (deucrictibant immediate-release capsules) for acute attacks of hereditary angioedema (HAE).

The presentations, announced via news release, were included in the “Flash Talks on Angioedema” session at the European Academy of Allergy & Clinical Immunology (EAACI) Hybrid Congress 2023, that took place in Hamburg, Germany, this June.

“The results from the Phase 2 RAPIDe-1 clinical study show that treatment of an HAE attack with PHVS416 resulted in rapid and clinically meaningful improvement in symptoms as compared to placebo,” said Peng Lu, M.D., Ph.D., chief medical officer of Pharvaris. “The study met the primary and all key secondary endpoints, providing evidence for the efficacy and tolerability of PHVS416 in treating HAE attacks and supports its further development as a potential on-demand therapy for HAE.”

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Patients with HAE and their physicians report that the most important factor in therapy selection is speed of symptom relief and that patients are anxious about injections and treatment effectiveness. Therefore, new oral therapies that work quickly and provide complete symptom relief are being investigated.

Read more about HAE therapies

PHVS416 is a highly potent and specific competitive antagonist of the bradykinin B2 receptor that is orally bioavailable.

The RAPIDe-1 study is a phase 2, randomized, double-blind and placebo-controlled trial of PHVS416 being conducted on 74 patients with HAE at centers in Canada, Europe, Israel, the UK, and the United States. One hundred forty-seven qualifying HAE attacks were treated with the study drug at 10, 20, or 30 mg doses or with placebo.

The presentations highlighted that the PHVS416 capsules met primary and key secondary endpoints, showing improved symptoms and shortened the time to symptom relief and HAE attack resolution along with an acceptable safety profile.  

Reference

Data of deucrictibant for the on-demand treatment of HAE attacks presented at the EAACI Congress 2023. News release. Pharvaris N.V.; June 10, 2023.

dermatologists deucrictibant IR Gastroenterologists immunologists Pharvaris PHVS416 RAPID-e1 study