European Commission Grants Orphan Designation to Pharvaris' Deucrictibant for Bradykinin-Mediated Angioedema
Key Insights
The European Commission has granted orphan designation to Pharvaris' investigational drug deucrictibant for treating bradykinin-mediated angioedema (search), following similar FDA designation in 2022.
Deucrictibant, an oral bradykinin B2 receptor (search) antagonist, is currently in Phase 3 clinical trials for hereditary angioedema (search) (HAE (search)) with potential to address broader bradykinin-mediated angioedema (search) conditions.
Pharvaris is developing two oral formulations of deucrictibant: an extended-release tablet for prophylactic treatment and an immediate-release capsule for on-demand therapy of angioedema attacks.
Pharvaris announced today that its investigational drug deucrictibant has received orphan designation from the European Commission (EC) for the treatment of bradykinin-mediated angioedema (search). This designation follows the U.S. Food and Drug Administration's (FDA) orphan drug designation granted to deucrictibant in March 2022 for the same indication.
Deucrictibant is a novel, oral bradykinin B2 receptor (search) antagonist being developed to address unmet needs in bradykinin-mediated diseases such as hereditary angioedema (search) (HAE (search)) and acquired angioedema due to C1 inhibitor deficiency (search) (AAE-C1INH (search)).
"By granting deucrictibant orphan designation for the treatment of bradykinin-mediated angioedema (search), the European regulators are acknowledging deucrictibant's ability as a bradykinin B2 receptor (search) 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.
Clinical Development Program
Pharvaris is currently executing a comprehensive Phase 3 development program evaluating deucrictibant's efficacy and safety in HAE (search). The company is conducting two pivotal Phase 3 studies:
- CHAPTER-3: Evaluating deucrictibant for the prevention of HAE attacks
- RAPIDe-3: Assessing deucrictibant for the on-demand treatment of HAE attacks
These studies follow positive results from earlier Phase 2 trials in both prophylactic and on-demand settings for HAE (search).
Dr. Lu emphasized the drug's potential broader applications: "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 (search) diseases, beyond HAE (search)."
The company is also in discussions with regulators regarding a pivotal trial in AAE-C1INH (search) to further explore deucrictibant's potential in treating additional bradykinin-mediated conditions.
Innovative Dual Formulation Strategy
Based on deucrictibant's chemical properties, Pharvaris is developing two distinct oral formulations:
- An extended-release tablet designed for sustained absorption and efficacy as prophylactic treatment
- An immediate-release capsule engineered for rapid onset of activity for on-demand treatment
This dual approach aims to provide patients with flexible treatment options that could potentially replace current injectable therapies with oral alternatives that maintain efficacy while improving convenience and quality of life.
Addressing Unmet Needs in Angioedema
Bradykinin-mediated angioedema (search) encompasses several conditions characterized by recurrent episodes of severe swelling affecting various body parts, including the face, throat, extremities, and gastrointestinal tract. These attacks can be painful, debilitating, and potentially life-threatening, particularly when affecting the airways.
Current treatment options for these conditions often involve injectable therapies, which can present challenges related to administration, convenience, and quality of life. Pharvaris aims to address these limitations by developing oral therapies that could potentially provide injectable-like efficacy with improved convenience.
About Pharvaris
Pharvaris (Nasdaq: PHVS) is a late-stage biopharmaceutical company focused on developing novel, oral bradykinin B2 receptor (search) antagonists to potentially address all types of bradykinin-mediated angioedema (search). The company's goal is to provide injectable-like efficacy with the convenience of oral therapy for both prevention and treatment of bradykinin-mediated angioedema attacks.
Headquartered in Zug, Switzerland, Pharvaris continues to advance its clinical programs with the aim of bringing new treatment options to patients living with these challenging conditions.