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news.Pharvaris has secured orphan designation from the European Commission (EC) for deucrictibant, an investigational drug for treating bradykinin-mediated angioedema.
The company develops oral bradykinin B2 receptor antagonists for addressing the bradykinin-mediated angioedema types. Credit: Trnava University on Unsplash.
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This announcement follows the US Food and Drug Administration’s (FDA) orphan drug designation granted to deucrictibant for the same indication in March 2022.
According to the company, this oral small-molecule bradykinin B2 receptor antagonist is presently undergoing clinical development.
The drug claims to inhibit the signalling of bradykinin via the bradykinin B2 receptor, and it may prevent the bradykinin-mediated angioedema attack occurrence and treat its manifestations.
The company is developing two oral formulations of the drug, which include an extended-release tablet for “sustained” efficacy and absorption as a prophylactic treatment.
Deucrictibant is also being developed as an immediate-release capsule for a quick onset of activity for on-demand treatment.
Pharvaris develops oral bradykinin B2 receptor antagonists for addressing the bradykinin-mediated angioedema types.
The company is assessing the drug’s efficacy and safety in pivotal Phase III trials for both the prevention and on-demand treatment of hereditary angioedema (HAE) attacks, building on positive data from Phase II prophylaxis and on-demand trials in HAE.
Pharvaris chief medical officer Peng Lu said: “Today, we are diligently executing our phase III development programme 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.
“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.”
