Pharvaris N.V. PHVS, a Netherlands-based clinical-stage company, announced that the FDA has lifted the clinical hold on the investigational new drug application for deucrictibant for the prophylactic treatment of hereditary angioedema (HAE) attacks.

A rare genetic disease, HAE, is marked by severe and potentially fatal swelling of the arms, legs, face and throat. The hold was lifted after the FDA reviewed data from a 26-week rodent toxicology study conducted by the company.

Pharvaris’ novel investigational candidate, deucrictibant, is an oral bradykinin B2 receptor antagonist to treat and prevent HAE attacks. The company is developing two formulations of deucrictibant, an immediate-release capsule formulation to enable rapid onset of activity for acute treatment and an extended-release tablet to enable sustained absorption and efficacy in prophylactic treatment. The extended-release formulation of the drug is being evaluated in a phase I study for the prophylaxis treatment of HAE.

The company is gearing up to progress the global development of deucrictibant for long-term prophylaxis after the FDA lifted the clinical hold in the United States. Pharvaris also plans to resume the open-label portion of its phase II proof-of-concept CHAPTER-1 study of deucrictibant for the prevention of HAE attacks in the country.

PHVS also expects to request a meeting with the FDA soon to align on key elements of the anticipated global phase III CHAPTER-3 study of deucrictibant extended-release tablets for the prophylactic treatment of HAE attacks.

The company’s stock rose 6.3% on Jan 22, in response to the news. In the past year, shares of Pharvaris have skyrocketed 186.8% against the industry’s 14.1% decline.

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We remind the investors that in August 2022, the FDA had placed clinical studies of deucrictibant, including the mid-stage CHAPTER-1 study, on hold. The clinical hold in the United States did not, however, affect the regulatory status of deucrictibant outside the country.

Consequently, in June 2023, the FDA removed the clinical hold of deucrictibant for the on-demand treatment of HAE in the United States. The decision was reached after the regulatory body reviewed the data from a preplanned interim analysis of a 26-week rodent toxicology study.

Recently, the company also announced positive top-line results from its phase II CHAPTER-1 study of deucrictibant for the prophylactic treatment of HAE attacks.

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