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EcoNail

Phase 2

Onychomycosis | Small molecule | Other |Abeona Therapeutics Inc.|Last Updated: Sep 3, 2020

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 Enrollment40
FDA Designations
ORPHAN_DRUG
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00385502A Trial of the Safety and Efficacy of EcoNail™ in the Treatment of Fungus Infections of the Great ToenailPHASE2 COMPLETED 40Sep 1, 2006Jun 1, 2008Sep 3, 20203 United States
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Study Endpoints
Primary Endpoints
Determine effectiveness of EcoNail™ lacquer, as determined by effects on nail mycology and appearance, when applied daily for 48 weeks to diseased great toenails in subjects with onychomycosis.
Week 48
Secondary Endpoints
Evaluate the safety and local tolerability of EcoNail™ lacquer under the same circumstances.
Week 56
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
EcoNail™EXPERIMENTALeconazole 5%/SEPA® 18% nail lacquer
Interventions
NameTypeDescription
EcoNail™ (econazole 5%/SEPA® 18% nail lacquer)DRUGnail lacquer applied daily for 48 weeks
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * Subjects who are men and women greater than or equal to 18 years of age and less than or equal to 65 years of age. * Female subjects who are post-menopausal (amenorrheic for at least 1 year), surgically sterile, have a partner with a vasectomy, or routinely using an acceptable...

Countries:United States
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