Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ARIKACE · 1 trial · 1 indication
Changes in chemistry and hematology lab tests (clinically significant value of CTCAE grade ≥ 3).
| Arm | Type | Description |
|---|---|---|
| Cohort 1 - 280 mg ARIKACE™ | EXPERIMENTAL | Subjects in this cohort will receive 280 mg of ARIKACE™ |
| Cohort 1 - Placebo | PLACEBO_COMPARATOR | Subjects in this arm of cohort 1 will receive matching placebo |
| Cohort 2 - 560 mg ARIKACE™ | EXPERIMENTAL | Subjects in this cohort will receive 560 mg of ARIKACE™ |
| Cohort 2 - Placebo | PLACEBO_COMPARATOR | Subjects in this arm of cohort 2 will receive matching placebo |
| Name | Type | Description |
|---|---|---|
| ARIKACE™ | DRUG | Study start date is before Jan 18, 2017. |
| Placebo | DRUG | Study start date is before Jan 18, 2017. |
Inclusion Criteria: * Written informed consent obtained from patient or designated legal guardian prior to the performance of any study related procedures. * Male or female study subjects ≥6 years of age or older * Confirmed diagnosis of CF * History of chronic infection with P. aeruginosa * Study ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Vertex Pharmaceuticals Incorporated | VRTX | 8 | PHASE3 | VX-121/TEZ/D-IVA |
| Sionna Therapeutics, Inc. | SION | 2 | PHASE2 | SION-719 |
| BiomX Inc. | PHGE | 1 | PHASE2 | BX004 |
| 4D Molecular Therapeutics, Inc. | FDMT | 1 | PHASE2 | 4D-710 |
| Arcturus Therapeutics Holdings, Inc. | ARCT | 1 | PHASE2 | ARCT-032 |
| Krystal Biotech, Inc. | KRYS | 1 | PHASE1 | KB407 |
| Illumina, Inc. | ILMN | 1 | - | Undisclosed |
ARIKACE is an investigational small molecule being developed for Cystic Fibrosis. It is a liposomal amikacin formulation for inhalation, intended to deliver the antibiotic directly to the lungs. As of the available data, it is in Phase 1 clinical development and has not been approved by regulatory authorities.
ARIKACE is a liposomal formulation of amikacin, an aminoglycoside antibiotic. Amikacin works by binding to the bacterial 30S ribosomal subunit, which interferes with protein synthesis and leads to bacterial cell death. This mechanism is relevant for treating lung infections in Cystic Fibrosis patients.
ARIKACE is being developed by Insmed Incorporated, a biopharmaceutical company. Insmed's stock is traded under the ticker symbol INSM. The company is conducting clinical trials to evaluate the safety and tolerability of ARIKACE in patients with Cystic Fibrosis.
ARIKACE is in Phase 1 clinical development. A Phase 1 trial has been completed, which studied multidose safety and tolerability with dose escalation of liposomal amikacin for inhalation. The drug remains investigational and is not yet approved for any use.
ARIKACE has one completed clinical trial registered as NCT00777296, titled 'Multidose Safety and Tolerability Study of Dose Escalation of Liposomal Amikacin for Inhalation (ARIKACE™)'. This Phase 1 study enrolled 66 participants with Cystic Fibrosis across multiple European countries, including Belgium, Hungary, North Macedonia, Poland, Serbia, Slovakia, and Ukraine.
Yes, ARIKACE is a brand name for liposomal amikacin for inhalation. The clinical trial NCT00777296 refers to it as 'Liposomal Amikacin for Inhalation (ARIKACE™)'. This formulation is designed for aerosol delivery to treat respiratory infections in Cystic Fibrosis patients.