Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MP-376 · 6 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 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) \[TOBI® Novartis Pharmaceuticals\] |
| Placebo | PLACEBO_COMPARATOR | Placebo inhaled twice daily via the PARI eFlow nebulizer for 5 consecutive days within a 28-day treatment cycle for up to 12 cycles |
| 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 |
| MP-376 | DRUG | MP-376 administered via inhalation for 5 consecutive days within 28-day treatment cycles for up to 12 cycles |
| Placebo | DRUG | same frequency as study drug using the same method of delivery |
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...
| 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 |
MP-376 is an investigational small molecule being developed by Amgen Inc. (AMGN) for respiratory conditions, specifically cystic fibrosis and chronic obstructive pulmonary disease (COPD). It has been studied in clinical trials for these indications, though it is not yet approved and remains in clinical development.
MP-376 is being developed by Amgen Inc., a biopharmaceutical company traded on NASDAQ under the ticker AMGN. Amgen has sponsored clinical trials of MP-376 in patients with cystic fibrosis and chronic obstructive pulmonary disease.
MP-376 has completed Phase 1 and Phase 2 clinical trials. It is an investigational drug and is not FDA approved. The most advanced completed trials are Phase 2 studies in cystic fibrosis and chronic obstructive pulmonary disease.
MP-376 has been studied in four completed clinical trials. These include NCT00503490, a Phase 1 study in cystic fibrosis; NCT00677365, a Phase 2 study in cystic fibrosis; NCT00739648, a Phase 2 study in COPD; and NCT00752414, a Phase 1b study in COPD.
MP-376 is an inhaled formulation of the antibiotic levofloxacin, developed for respiratory conditions. It has been evaluated in clinical trials for cystic fibrosis and chronic obstructive pulmonary disease, with the goal of delivering the drug directly to the lungs.