Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as MP-376 (Levofloxacin solution for Inhalation), Levofloxacin inhalation solution, Aeroquin
MP-376 · 7 trials · 3 indications
An AE was defined as any unfavorable or unintended sign, symptom, or disease temporally associated with the use of a Study Drug, whether or not considered related to the Study Drug. An AE could potentially be a new disease, any untoward event, or an exacerbation of a pre-existing condition. AEs included, but were not limited to: Any symptom not previously reported by the patient (medical history) An exacerbation of a pre-existing illness An increase in frequency or intensity of a pre-existing episodic event or condition A condition first detected or diagnosed after Study Drug administration even though the condition may have been present before the start of the study Overdose of Study Drug
FEV1 was the volume of air exhaled in first second of a forced expiration as measured by spirometer. Least squares (LS) mean and standard error (SE) were determined from an analysis of covariance model with terms for treatment, region (US, non-US), and age (12 to 18 years, \> 18 years), and Baseline FEV1 (\< 55%, . 55%).
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.
The number of acute exacerbations per patient-year of study participation, where an acute exacerbation was defined as a deterioration in respiratory symptoms that required treatment with antibiotics, corticosteroids, hospitalization or a combination of those treatments.
Patients were required to cough deeply and then spit sputum into a sterile container. The bacteria contained in the sputum sample was incubated in a laboratory and the number of P. aeruginosa colony forming units per gram of sputum (CFU/g) was determined. The difference in CFUs/g were then compared from baseline to the conclusion of the 28 day treatment period
| Arm | Type | Description |
|---|---|---|
| Aeroquin | EXPERIMENTAL | Aeroquin, Inhaled Levofloxacin (MP-376) |
| TIS | ACTIVE_COMPARATOR | Tobramycin Inhalation solution (TIS) \[TOBI® Novartis Pharmaceuticals\] |
| 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. |
| MP-376 240 mg Twice Daily (BID) | EXPERIMENTAL | MP-376 240 mg BID inhaled via the PARI eFlow nebulizer for 5 consecutive days within a 28-day treatment cycle for up to 12 cycles |
| MP-376 120 mg QD | EXPERIMENTAL | MP-376 120 mg inhaled Once Daily (QD) via the PARI eFlow nebulizer for 28 days |
| MP-376 240 mg QD | EXPERIMENTAL | MP-376 240 mg inhaled QD bia the PARI eFlow nebulizer for 28 days |
| MP-376 240 mg BID | EXPERIMENTAL | MP-376 240 mg inhaled twice daily (BID) via the PARI eFlow nebulizer for 28 days |
| 1 | EXPERIMENTAL | CF PATIENTS 6-11 YEARS OF AGE |
| 2 | EXPERIMENTAL | CF PATIENTS 12-16 YEARS OF AGE |
| Name | Type | Description |
|---|---|---|
| MP-376 (Levofloxacin Solution for Inhalation) | DRUG | MP-376 (Aeroquin, Levofloxacin solution for Inhalation) 240 mg administered BID for 28-days treatment followed by 28 days off treatment |
| TIS (Tobramycin Inhalation Solution) | DRUG | Tobramycin Inhalation Solution administered BID over 3 consecutive cycles of 28-days treatment followed by 28 days off treatment |
| Aeroquin | DRUG | Inhalation Solution |
| Placebo | DRUG | Inhalation Solution |
| MP-376 | DRUG | MP-376 administered via inhalation for 5 consecutive days within 28-day treatment cycles for up to 12 cycles |
Inclusion Criteria (selected): * \> 12 years of age * Confirmed Diagnosis of Cystic Fibrosis * Positive sputum culture for P. aeruginosa within the past 12 months * Patients are able to elicit an FEV1 \>/= 25% but \</= 85% of predicted value at screening * Have received at least 3 courses of inhale...
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 |
MP-376 is an inhaled levofloxacin solution developed by Amgen Inc. (ticker AMGN) as a small molecule therapy for respiratory conditions. It is also known as MP-376 (Levofloxacin Solution for Inhalation). The drug has been studied in cystic fibrosis and chronic obstructive pulmonary disease and remains in clinical development.
MP-376 has been studied in cystic fibrosis and chronic obstructive pulmonary disease. In cystic fibrosis, it was tested against tobramycin inhalation solution. In COPD, it was evaluated to prevent acute exacerbations. Both indications were explored in completed clinical trials, and the drug is not approved for either use.
MP-376 is developed by Amgen Inc., which trades on Nasdaq under the ticker AMGN. Amgen is the sponsor associated with the clinical development program for this inhaled levofloxacin formulation across cystic fibrosis and chronic obstructive pulmonary disease studies.
MP-376 is in Phase 2 development. Four clinical trials have been completed, including Phase 1, Phase 1b, Phase 2, and Phase 3 studies, and none are currently active. The drug is investigational and has not been approved by the FDA for any indication.
MP-376 has completed four trials: NCT01270347, a Phase 3 study of Aeroquin versus tobramycin inhalation solution in cystic fibrosis; NCT00840333, a Phase 1 pediatric cystic fibrosis study; NCT00752414, a Phase 1b COPD study; and NCT00739648, a Phase 2 COPD exacerbation prevention study. All are completed.
MP-376 is also known as MP-376 (Levofloxacin Solution for Inhalation). The Phase 3 cystic fibrosis trial NCT01270347 refers to the study drug as Aeroquin. These names refer to the same inhaled levofloxacin formulation developed by Amgen Inc. for respiratory indications.