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FP01

Phase 2

Chronic Refractory Cough | Small molecule | Other |Avalo Therapeutics, Inc.|Last Updated: Nov 5, 2014

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-BlindCONTROLLEDBiomarker
Total Trials1
Total Enrollment83
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01703923An Exploratory Study of FP01 Lozenges in Subjects With Chronic Refractory CoughPHASE2 COMPLETED 83Nov 1, 2012Sep 1, 2013Nov 5, 20148 United States
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Study Endpoints
Primary Endpoints
Cough Count/Frequency
Day 0-1, Day 14-15; Day 28-29, Day 42-43

Change in start-to-end difference in cough count, active vs. placebo treatment periods

Secondary Endpoints
LCQ
Days 0, 14, 28, & 42
VAS Score
Days 1, 14, 28, & 42
Cough Severity Diary
Days 0, 14, 28, & 42
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
FP01 6mg or PlaceboEXPERIMENTALFP01 6mg Oral
FP01 12mg or PlaceboEXPERIMENTALFP01 12mg Oral
Interventions
NameTypeDescription
FP01DRUG -
placeboDRUG -
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersYes
Study Sites8

Inclusion Criteria: * Subject must sign an Institutional Review Board approved informed consent and agree to complete required clinic visits * Subjects must be able to read and write English * Subject must exceed a cough severity threshold (VAS) during screening visit (Cough Severity VAS Score ≥ 35...

Countries:United States
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