Pharvaris Angiodema Trials Placed on Clinical Hold

The FDA has placed a clinical hold on Pharvaris’s investigational drug PHA121 for treatment of patients with hereditary angioedema, a disorder characterized by recurrent episodes of severe swelling.

The agency placed the hold following a review of nonclinical data, the company said, adding that it is now in discussions with the FDA about how to proceed.

“We are fully committed to working closely with the FDA to address the agency’s concerns,” said Pharvaris CEO Berndt Modig.

PHA121 is a bradykinin B2 receptor antagonist that blocks bradykinin signaling through its B2 receptor. Bradykinin-mediated signaling plays a role in inflammation, chronic pain and several other conditions.