Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Deucrictibant · 5 trials · 18 indications
Time-normalized number of Investigator-confirmed AAE attacks during Treatment Phase
Time to symptom relief, Patient Global Impression of Change (PGI-C) rating of at least "better"
Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events of special interest (AESIs), and TEAEs leading to study drug discontinuation
Hematology, blood chemistry, and urinalysis. Descriptive in nature, no formal statistical hypothesis testing will be performed.
Digital triplicate 12-lead ECG. Descriptive in nature, no formal statistical hypothesis testing will be performed.
Descriptive in nature, no formal statistical hypothesis testing will be performed.
Systolic and diastolic blood pressure will be measured. Descriptive in nature, no formal statistical hypothesis testing will be performed.
Descriptive in nature, no formal statistical hypothesis testing will be performed.
hematology, blood chemistry, urinalysis
The primary endpoint of the study was the change of the VAS-3 (3-symptom composite visual analogue scale) score from pre-treatment to 4 hours post-treatment. The VAS-3 was calculated as the mean of the VAS scores of the 3 major HAE symptoms: skin swelling, skin pain, and abdominal pain. The VAS scores of the 3 major HAE symptoms (skin swelling, skin pain, and abdominal pain) could range between 0 (No swelling/No pain) and 100 (Extreme swelling/Excruciating pain)
| Arm | Type | Description |
|---|---|---|
| Part 1 - Arm 1 - Active | EXPERIMENTAL | - |
| Part 1 - Arm 2 - Placebo | PLACEBO_COMPARATOR | - |
| Part 2 - Arm 1 | EXPERIMENTAL | - |
| Part 2 - Arm 2 | EXPERIMENTAL | - |
| Part 3 - Open-label | EXPERIMENTAL | - |
| Deucrictibant | EXPERIMENTAL | Deucrictibant |
| Active | EXPERIMENTAL | Deucrictibant 40mg extended-release tablet by mouth once daily |
| Placebo | EXPERIMENTAL | Placebo 1 tablet by mouth once daily |
| Part A: Deucrictibant, blinded dose | EXPERIMENTAL | Participants will receive the dose of deucrictibant they were randomized to in the PHA022121-C201 study (low, medium, or high dose, each consisting of 3 capsules of deucrictibant or matching placebo) for oral use for on-demand treatment of HAE attacks. |
| Part B: Deucrictibant, open-label | EXPERIMENTAL | Participants will receive deucrictibant soft capsules for oral use for on-demand treatment of HAE attacks. |
| Low dose/placebo | OTHER | Single low dose of deucrictibant or placebo |
| Medium dose/placebo | OTHER | Single medium dose of deucrictibant or placebo |
| High dose/placebo | OTHER | Single high dose of deucrictibant or placebo |
| Name | Type | Description |
|---|---|---|
| Deucrictibant | DRUG | Part 1: Deucrictibant 40 mg extended-release tablet for once daily oral use |
| Placebo | DRUG | Part 1: Placebo Comparator tablet for once daily oral use |
Inclusion Criteria: * Provision of written informed consent * Male or female (sex at birth) aged ≥18 years * Diagnosis of AAE-C1INH * History of AAE-C1INH attacks prior to the Screening Visit: * Participants enrolling in Part 1 must have stable underlying disease of AAE-C1INH * The underlying co...
Deucrictibant is an investigational small molecule being developed for hereditary angioedema (HAE) and acquired angioedema due to C1-inhibitor deficiency (AAE-C1-INH). It is being studied as an oral extended-release tablet for prophylaxis against angioedema attacks and as an immediate-release capsule for on-demand treatment of attacks.
Deucrictibant targets the bradykinin pathway. It is designed to block bradykinin signaling, which is involved in the swelling attacks characteristic of hereditary angioedema and acquired angioedema due to C1-inhibitor deficiency.
Deucrictibant is being developed by Pharvaris N.V., a biopharmaceutical company traded on NASDAQ under the ticker PHVS. Pharvaris is conducting Phase 3 clinical trials of Deucrictibant for hereditary angioedema and acquired angioedema due to C1-inhibitor deficiency.
Deucrictibant is in Phase 3 clinical development. It is investigational and not yet approved by the FDA. The drug has received orphan drug designation from the FDA for its target indications.
Deucrictibant is being studied in several trials. NCT07266805 is a Phase 3 study in acquired angioedema due to C1-inhibitor deficiency. NCT06679881 and NCT06669754 are Phase 3 studies in hereditary angioedema for prophylaxis. NCT05396105 is a Phase 2 extension study for acute treatment of HAE attacks.
Yes, Deucrictibant is also known as PHA-022121. The Phase 2 extension study NCT05396105 refers to oral PHA-022121 for acute treatment of angioedema attacks in patients with hereditary angioedema, which is the same drug candidate.