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Interferon alpha lozenge

Phase 2

Respiratory Tract Diseases | Small molecule | Respiratory |Ainos, Inc.|Last Updated: Apr 20, 2012

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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment18
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01442779Clinical Trial of Low Dose Oral Interferon Alpha in Idiopathic Pulmonary FibrosisPHASE2 COMPLETED 18Sep 1, 2000May 1, 2007Apr 20, 20121 United States
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Study Endpoints
Primary Endpoints
Minimal/no Progression (1 yr) by High Resolution Computed Tomography (HRCT) & Pulmonary Function
1 yr

Disease progression was determined by comparing results of the High Resolution Computed Tomography(HRCT) and pulmonary function at one year to the baseline HRCT \& pulmonary function. The same radiologist did the comparsion for all subjects.

Minimal/no Change in Quality of Life
12 months
Secondary Endpoints
Participants With Change in Cough
1 month
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Interventions
NameTypeDescription
Interferon alpha oral lozengeDRUGdose form - oral lozenge dose - 150 International Units (IU) frequency - 3 times a day duration - at least 1 year
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Eligibility Criteria
Age Range50 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * The only subjects to be included in this study are those diagnosed with Idiopathic Pulmonary Fibrosis with diagnosis based on the criteria published by the American Thoracic Society in the International Consensus Statement. 1. Exclusion of other known causes of interstitial...

Countries:United States
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