Pharvaris: EU orphan designation granted for treatment of bradykinin-mediated angioedema

Pharvaris (Nasdaq: PHVS), a late-stage biopharmaceutical company developing novel, oral bradykinin B2 receptor antagonists to help address unmet needs of those living with bradykinin-mediated diseases such as hereditary angioedema (HAE) and acquired angioedema due to C1 inhibitor deficiency (AAE-C1INH), today announced that the European Commission (EC) has granted orphan designation to its investigational drug, deucrictibant, for the treatment of bradykinin-mediated angioedema.

The U.S. Food and Drug Administration (FDA) previously granted orphan drug designation to deucrictibant for the treatment of bradykinin-mediated angioedema in March 2022.

“Today, we are diligently executing our phase 3 development program evaluating the efficacy and safety of deucrictibant in HAE. By granting deucrictibant orphan designation for the treatment of bradykinin-mediated angioedema, the European regulators are acknowledging deucrictibant’s ability as a bradykinin B2 receptor antagonist to address the unmet needs associated with any bradykinin-mediated angioedema condition,” said Peng Lu, M.D., Ph.D., Chief Medical Officer of Pharvaris. “By blocking the effects of bradykinin, the ultimate culprit inducing angioedema attacks, regardless of its source, deucrictibant has the potential to offer a broader-acting option to address the unmet need associated with bradykinin-mediated angioedema diseases, beyond HAE. To provide further evidence for that hypothesis, we are currently discussing a pivotal trial in AAE-C1INH with regulators.”

About Deucrictibant
Deucrictibant is a novel, potent, oral small-molecule bradykinin B2 receptor antagonist currently in clinical development. By inhibiting bradykinin signaling through the bradykinin B2 receptor, deucrictibant is being investigated for its potential to prevent the occurrence of bradykinin-mediated angioedema attacks and to treat the manifestations of attacks if/when they occur. Based on its chemical properties, Pharvaris is developing two formulations of deucrictibant for oral administration: an extended-release tablet to enable sustained absorption and efficacy as prophylactic treatment, and an immediate-release capsule to enable rapid onset of activity for on-demand treatment. Deucrictibant has been granted orphan drug designation by the U.S. Food and Drug Administration and orphan designation by the European Commission.