Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Aeroquin · 1 trial · 1 indication
The start of the exacerbation was determined by the earliest date at which a participant concurrently met at least 4 of the 12 modified Fuchs symptoms/signs; discontinued from the study early; died; or received an antipseudomonal agent for an event that did not meet modified Fuchs criteria but was determined to be an exacerbation by the Blinded Exacerbation. Fuchs symptoms/signs; * Change in sputum * New or increased hemoptysis * Increased cough * Increased dyspnea * Malaise, fatigue or lethargy * Temperature above 38oC * Anorexia or weight loss * Sinus pain or tenderness * Change in sinus discharge * Change in physical examination of the chest * Decrease in pulmonary function by 10 percent or more from a previously recorded value * Radiographic changes indicative of pulmonary infection Median and 95%Ci were estimated using Kaplan Meier estimates.
| Arm | Type | Description |
|---|---|---|
| Aeroquin 240 mg | EXPERIMENTAL | Participants received 240 milligrams (mg) of Aeroquin by inhalation route twice daily (BID) for a period of 28 days. |
| Placebo | PLACEBO_COMPARATOR | Participants placebo matching Aeroquin by inhalation route, BID for a period of 28 days. |
| Name | Type | Description |
|---|---|---|
| Aeroquin | DRUG | Inhalation Solution |
| Placebo | DRUG | Inhalation Solution |
Inclusion Criteria (selected): * \>/= 12 years of age * Confirmed Diagnosis of Cystic Fibrosis * Positive sputum culture for P. aeruginosa at screening and within the past 12 months * Patients are able to elicit an FEV1 \>/= 25% but \</= 85% of predicted value at screening * Have received at least ...
| 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 |
Aeroquin is an investigational small molecule being developed for the treatment of cystic fibrosis. It is a formulation of levofloxacin for inhalation, intended to deliver the antibiotic directly to the lungs. Aeroquin is currently in Phase 3 clinical development and is not yet approved by regulatory authorities.
Aeroquin contains levofloxacin, a fluoroquinolone antibiotic that targets bacterial DNA gyrase and topoisomerase IV, enzymes essential for bacterial DNA replication. By inhibiting these targets, Aeroquin is designed to treat lung infections in patients with cystic fibrosis. The drug is administered via inhalation to achieve high local concentrations in the airways.
Aeroquin is being developed by Amgen Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol AMGN. Amgen is conducting clinical trials to evaluate the safety and efficacy of Aeroquin in patients with cystic fibrosis. The drug is currently in Phase 3 development.
Aeroquin is in Phase 3 clinical development for the treatment of cystic fibrosis. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. A Phase 3 trial has been completed, and the drug remains under evaluation for potential regulatory submission.
Aeroquin has one completed Phase 3 clinical trial, identified as NCT01180634, titled 'MP-376 (Aeroquin™, Levofloxacin for Inhalation) in Patients With Cystic Fibrosis.' This randomized, double-blind, placebo-controlled trial enrolled 330 participants aged 12 years and older across the United States, Australia, Canada, Israel, and New Zealand.
Yes, Aeroquin is the brand name for levofloxacin for inhalation, also known as MP-376. The drug is a formulation of the antibiotic levofloxacin designed to be inhaled directly into the lungs. It is being developed specifically for the treatment of cystic fibrosis and is currently in Phase 3 clinical trials.