Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CINRYZE with rHuPH20 · 2 trials · 1 indication
Angioedema attack was defined as the participant-reported indication of symptoms or signs such as swelling or pain at any location following a report of no swelling or pain on the previous day. Manifestations of an attack that progress from one site to another, prior to complete resolution, was considered a single attack. Attacks that began to regress and then worsened before complete resolution was also considered one attack. Participants who were dosed but did not have any attacks in the period were assigned a value of zero. The number of attacks was normalized for the number of days participants participated in a given period and expressed as the monthly frequency.
| Arm | Type | Description |
|---|---|---|
| SC CINRYZE with rHuPH20 Dose Level 1 followed by Dose Level 2 | EXPERIMENTAL | SC CINRYZE with rHuPH20 Dose Level 1 twice weekly (every 3 or 4 days) for 8 weeks followed by SC CINRYZE with rHuPH20 Dose Level 2 twice weekly (every 3 or 4 days) for 8 weeks. |
| SC CINRYZE with rHuPH20 Dose Level 2 followed by Dose Level 1 | EXPERIMENTAL | SC CINRYZE with rHuPH20 Dose Level 2 twice weekly (every 3 or 4 days) for 8 weeks followed by SC CINRYZE with rHuPH20 Dose Level 1 twice weekly (every 3 or 4 days) for 8 weeks. |
| 500 U CINRYZE (10-25 kg body weight) | EXPERIMENTAL | Single IV dose of 500 U CINRYZE |
| 1000 U CINRYZE (10-25 kg body weight) | EXPERIMENTAL | Single IV dose of 1000 U CINRYZE |
| 1000 U CINRYZE (>25 kg body weight) | EXPERIMENTAL | Single IV dose of 1000 U CINRYZE |
| 1500 U CINRYZE (>25 kg body weight) | EXPERIMENTAL | Single IV dose of 1500 U CINRYZE |
| Name | Type | Description |
|---|---|---|
| CINRYZE with rHuPH20 | BIOLOGICAL | - |
| CINRYZE | BIOLOGICAL | - |
Inclusion Criteria: * Be ≥12 years of age. * Have a confirmed diagnosis of Hereditary Angioedema. Exclusion Criteria: * Receipt of any C1 inhibitor (C1 INH) therapy or any blood products for treatment or prevention of an angioedema attack within 7 days before the first dose of study drug. * Be re...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Intellia Therapeutics, Inc. | NTLA | 3 | PHASE3 | NTLA-2002, Normal Saline Administration |
| BioCryst Pharmaceuticals, Inc. | BCRX | 2 | PHASE3 | Berotralstat |
| Ionis Pharmaceuticals, Inc. | IONS | 1 | PHASE3 | Donidalorsen |
| Pharvaris N.V. | PHVS | 1 | PHASE2 | deucrictibant |
| BioMarin Pharmaceutical Inc. | BMRN | 1 | PHASE1 | Dose 1 of BMN 331 |
| Astria Therapeutics, Inc. | ATXS | 1 | PHASE2 | STAR-0215 |
CINRYZE is used for the treatment and prevention of attacks of hereditary angioedema (HAE), a rare genetic disorder characterized by recurrent episodes of severe swelling. It is being studied in clinical trials for patients with HAE, including children under the age of 12.
CINRYZE is developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. Takeda is conducting clinical trials to evaluate the safety and efficacy of CINRYZE for hereditary angioedema.
CINRYZE is in Phase 2 clinical development. It is an investigational therapy for hereditary angioedema and has not yet been approved by regulatory authorities. Clinical trials are ongoing to assess its safety and effectiveness.
CINRYZE has been studied in several Phase 2 trials. These include NCT01095497, evaluating subcutaneous administration; NCT01095510, for children under 12; NCT01426763, testing subcutaneous delivery with recombinant human hyaluronidase; and NCT01756157, for prevention of angioedema attacks. All trials are completed.
Yes, CINRYZE is a monoclonal antibody. It is being developed as a treatment for hereditary angioedema, a condition marked by recurrent swelling episodes. Clinical trials have assessed its use in both adults and children.