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Aeroquin

Phase 3

Cystic Fibrosis | Small molecule | Respiratory |Amgen Inc.|Last Updated: Dec 18, 2024

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment330
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01180634MP-376 (Aeroquin™, Levofloxacin for Inhalation) in Patients With Cystic FibrosisPHASE3 COMPLETED 330Nov 4, 2010May 7, 2012Dec 18, 2024112 United States, Australia +3
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Study Endpoints
Primary Endpoints
Time to an Exacerbation
Baseline to end of study (up to 59 days)

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.

Secondary Endpoints
Absolute Change in Percent Predicted Forced Expiratory Volume in One Second (FEV1)
Baseline, day 28
Change From Baseline in Pseudomonas Aeruginosa Sputum Density
Baseline, Day 28
Change From Baseline in the Respiratory Domain of the Cystic Fibrosis Questionnaire Revised (CFQ-R)
Baseline, Day 28
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Aeroquin 240 mgEXPERIMENTALParticipants received 240 milligrams (mg) of Aeroquin by inhalation route twice daily (BID) for a period of 28 days.
PlaceboPLACEBO_COMPARATORParticipants placebo matching Aeroquin by inhalation route, BID for a period of 28 days.
Interventions
NameTypeDescription
AeroquinDRUGInhalation Solution
PlaceboDRUGInhalation Solution
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Eligibility Criteria
Age Range12 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites112

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 ...

Countries:United StatesAustraliaCanadaIsraelNew Zealand
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