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Also known as TR02
SLIT Amikacin · 1 trial · 1 indication
Safety and tolerability of three active doses of nebulized amikacin in a SLIT™ formulation.
| Arm | Type | Description |
|---|---|---|
| Cohort 1: Amikacin Dose 1 + Placebo | EXPERIMENTAL | Participants will receive a single dose of SLIT™ amikacin at Dose 1 or matching placebo by inhalation on Day 0. |
| Cohort 2: Amikacin Dose 2 + Placebo | EXPERIMENTAL | Participants will receive a single dose of SLIT™ amikacin at Dose 2 or matching placebo by inhalation on Day 0 upon initiation of Cohort 2. |
| Cohort 3: Amikacin Dose 3 + Placebo | EXPERIMENTAL | Participants will receive a single dose of SLIT™ amikacin at Dose 3 or matching placebo by inhalation on Day 0 upon initiation of Cohort 3. |
| Name | Type | Description |
|---|---|---|
| SLIT™ Amikacin | DRUG | Amikacin administered via the Pari LC STAR™ nebulizer. |
| Placebo | DRUG | Nebulized saline. |
Inclusion Criteria: * Study participants must produce sputum that is positive for Pseudomonas aeruginosa. * Confirmed diagnosis of CF (positive sweat chloride \>60 milliequivalents (mEq)/liter (by pilocarpine iontophoresis) and/or a genotype with two identifiable mutations consistent with CF accomp...
Top 6 of 7 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Vertex Pharmaceuticals Incorporated | VRTX | 8 | PHASE3 | Alyftrek, Trikafta, Ivacaftor, VX-581, VX-272 |
| 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 |
| Roivant Sciences Ltd. | ROIV | 1 | PHASE1 | SP-101 |
SLIT Amikacin is an investigational inhaled antibiotic developed by Insmed Incorporated for cystic fibrosis. It uses Sustained Lipid Inhalation Technology, or SLIT, to deliver amikacin, and it is also written as SLIT™ Amikacin. It is a small molecule in Phase 1 development and has been studied in people with cystic fibrosis who have chronic Pseudomonas aeruginosa infections.
SLIT Amikacin is being developed for cystic fibrosis in patients who have chronic infections of Pseudomonas aeruginosa. The single completed Phase 1 trial enrolled 18 adults aged 18 years and older with cystic fibrosis and these chronic infections. It is investigational and has not been approved for any use.
SLIT Amikacin is developed by Insmed Incorporated, which trades on the Nasdaq under the ticker INSM. Insmed is the sponsor of the Phase 1 study of the asset, which is also referred to as TR02 in that trial.
SLIT Amikacin is in Phase 1 development. One Phase 1 trial has been completed, and no active trials are ongoing. The drug is investigational and has not been approved by the FDA for cystic fibrosis or any other indication.
SLIT Amikacin has been studied in one completed Phase 1 trial, NCT06238856. That trial was a single dose escalation study of TR02, also called SLIT™ Amikacin, in participants with cystic fibrosis who have chronic Pseudomonas aeruginosa infections. It was randomized, double blind, and controlled, and it enrolled 18 participants.
Yes. SLIT Amikacin and SLIT™ Amikacin refer to the same investigational asset from Insmed Incorporated. The trial listing for NCT06238856 uses the name TR02 along with Sustained Lipid Inhalation Technology, or SLIT, Amikacin, so TR02 is another name used for this program.