Deucrictibant Clinical Trials in HAE

Deucrictibant is a novel, potent, orally bioavailable small-molecule bradykinin B2 receptor antagonist designed to prevent the occurrence of bradykinin-mediated angioedema attacks and to treat the manifestations of attacks if/when they occur by inhibiting bradykinin signaling through the bradykinin B2 receptor, a proven mechanism for the treatment of attacks.

Pharvaris is currently evaluating the efficacy and safety of deucrictibant in a pivotal Phase 3 study for the prevention of HAE attacks (CHAPTER-3) and a pivotal Phase 3 study for the on-demand treatment of HAE attacks (RAPIDe-3).

People interested in participating in a clinical trial should speak with their physician.

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RAPIDe-3

Pivotal, phase 3, randomized clinical trial

Purpose – evaluating the efficacy and safety of an investigational oral drug, deucrictibant immediate-release capsule, compared to a placebo as a new therapeutic option to treat HAE attacks
Inclusion – people, aged 12 years or older, diagnosed with HAE, as well as other criteria

For more information:

RAPIDe-3 Website Clinical Trial

RAPIDe-2

Extension study

Purpose – evaluating the safety and efficacy of deucrictibant as a potential treatment for HAE attacks over a long period of time

For more information:

Clinical Trial

CHAPTER-3

Pivotal, phase 3, randomized clinical trial

Purpose – evaluating the efficacy and safety of an investigational once-daily oral drug, deucrictibant extended-release tablet, compared to a placebo as a new therapeutic option to prevent HAE attacks
Inclusion – people, aged 12 years or older, diagnosed with HAE, as well as other criteria

For more information, visit the links below:

CHAPTER-3 Website Clinical Trial

CHAPTER-4

extension study

Purpose – evaluating the safety and efficacy of deucrictibant as a potential preventative treatment for HAE attacks when it’s taken as a daily tablet over a long period of time

For more information, visit the links below:

CHAPTER-4 Website Clinical Trial

Learn more about the Expanded Access Policy

Expanded Access Policy

Pharvaris is committed to serving patients’ health needs by developing safe and effective therapies and making them available for use as quickly as possible. We believe that controlled clinical trials provide the best path for Pharvaris to generate the safety and efficacy information needed to obtain regulatory approval so that we can make our medicines available to all patients.

Pharvaris always seeks to provide the quickest and broadest access to its medicines, balancing benefit and risk to all patients. We support the principle of expanded-access programs consistent with the best standards for safe and effective use of an investigational therapy, as well as our ability to logistically provide a product. Pharvaris will consider requests for expanded access from qualified physicians, balancing multiple factors.

When evaluating potential use of an investigational therapy, we will consider several factors consistent with the U.S. Food and Drug Administration (FDA) and other regulatory agencies’ guidelines including both patient and scientific perspectives. Eligibility requirements include but are not limited to:

Sufficient scientific evidence to support both the safety and the efficacy of the compound’s mechanism for this indication.

A serious or life-threatening illness, with no other satisfactory treatment options (such as approved products or enrolling clinical trials).

Sufficient evidence that the potential benefit to the patient would likely outweigh the potential risks, based on all available safety and efficacy information.

Support that providing the investigational drug will not interfere with clinical trials that could support the investigational drug’s development or regulatory approval for the treatment indication, which could affect future patient access.

The evaluation of these, and other, questions may require additional investigation or interaction with  the requesting physician, other clinical investigators, or regulatory authorities. Favorable answers alone provide no guarantee that Pharvaris will be able to provide pre-approval access to an  experimental medicine.

Requests for access to investigational therapies must be made by a qualified and licensed physician to Pharvaris (expandedaccess@pharvaris.com) and will be evaluated by a core team. Pharvaris anticipates it will acknowledge receipt of such requests within five business days after receipt of an inquiry. Pharvaris may revise this policy at any time.