FDA Clears Pharvaris' Trial For Investigational Drug For Swollen Blood Vessels, Stock Jumps

Pharvaris NV PHVS announced that the FDA has lifted the clinical hold on the Investigational New Drug (IND) application for deucrictibant for the prophylactic (used to prevent a disease or condition) treatment of hereditary angioedema (HAE) attacks following a review of data from a 26-week rodent toxicology study.

HAE affects the blood vessels. An HAE attack can result in rapid swelling of the hands, feet, limbs, face, intestinal tract, larynx (voicebox), or trachea (windpipe).

“The lift of the clinical hold in the U.S. enables us to progress the global development of deucrictibant for long-term prophylaxis, including resuming the open-label portion of CHAPTER-1, our Phase 2 proof-of-concept study of deucrictibant for the prevention of HAE attacks, in the U.S.,” said Berndt Modig, Chief Executive Officer of Pharvaris.

“We will request an End-of-Phase 2 meeting with the FDA to align on key elements of CHAPTER-3, the anticipated global Phase 3 study of deucrictibant extended-release tablets (PHVS719) for the prophylactic treatment of HAE attacks,” Modig added.

In August 2022, the FDA placed deucrictibant clinical studies, including CHAPTER-1, on hold. 

In June 2023, Pharvaris announced the FDA’s removal of the clinical hold of deucrictibant for the on-demand treatment (used to stop the progression of the swelling and to relieve the symptoms) of HAE in the U.S. following an FDA review of data from a preplanned interim analysis of a 26-week rodent toxicology study.

In December 2023, Pharvaris announced top-line clinical data from the Phase 2 CHAPTER-1 study of deucrictibant for the prophylactic treatment of HAE attacks.

Price Action: PHVS shares are up 6.30% at $29.01 on the last check Monday.