Drugs

Pharvaris Clinical Hold Lifted

FDA has lifted a clinical hold against a Pharvaris IND for deucrictibant, an investigational therapy for the prophylactic treatment of hereditary angioedema (HAE) attacks. The agency action follows its review of data from a 26-week rodent toxicology study, the company says.

The original hold has placed 8/2022. In 6/2023, the agency removed the clinical hold for deucrictibant on-demand treatment of HAE in the U.S. after FDA reviewed data from a preplanned interim analysis of a 26-week rodent toxicology study, the company says. Meanwhile, Pharvaris last month announced positive top-line clinical data from the Phase 2 CHAPTER-1 study of deucrictibant for the prophylactic treatment of HAE attacks.

“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.,” Pharvaris says. “We are pleased to have worked collaboratively with the FDA to address the requests of the agency with the submission of additional nonclinical data, and we appreciate the agency’s comments and recommendations regarding study conduct. 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.”

Deucrictibant is described as a potent, selective, and orally available antagonist of the bradykinin B2 receptor. “By inhibiting bradykinin signaling through the bradykinin B2 receptor, deucrictibant has the potential to treat the clinical signs of an HAE attack and to prevent the occurrence of attacks,” Pharvaris says.

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