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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...
| 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 |
SLIT Amikacin is an investigational small molecule being developed for Cystic Fibrosis. It is designed as a single dose escalation study in participants with Cystic Fibrosis who have chronic infections of Pseudomonas aeruginosa. The drug is administered via Sustained Lipid Inhalation Technology (SLIT) and is currently in Phase 1 clinical development.
SLIT Amikacin is an amikacin formulation that targets Pseudomonas aeruginosa infections in patients with Cystic Fibrosis. Amikacin is an aminoglycoside antibiotic that works by inhibiting bacterial protein synthesis, thereby killing the bacteria. The SLIT technology provides sustained delivery of the drug to the lungs.
SLIT Amikacin is being developed by Insmed Incorporated, a biopharmaceutical company traded on NASDAQ under the ticker INSM. The company is conducting clinical trials to evaluate the safety and tolerability of this inhaled amikacin formulation in patients with Cystic Fibrosis.
SLIT Amikacin is in Phase 1 clinical development. A Phase 1 single dose escalation study has been completed, involving 18 participants with Cystic Fibrosis. The drug is investigational and has not been approved by regulatory authorities. Further clinical trials are needed to establish its safety and efficacy.
SLIT Amikacin has one completed clinical trial, NCT06238856, titled 'Single Dose Escalation Study of TR02 (Sustained Lipid Inhalation Technology [SLIT™] Amikacin) in Participants With Cystic Fibrosis (CF) Having Chronic Infections of Pseudomonas Aeruginosa.' This Phase 1 study enrolled 18 participants and was a randomized, double-blind, controlled trial.
Yes, SLIT Amikacin is also known as TR02. The clinical trial NCT06238856 refers to the drug as TR02 (Sustained Lipid Inhalation Technology [SLIT™] Amikacin). Both names refer to the same investigational amikacin formulation being developed by Insmed for Cystic Fibrosis.