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FMX101

Phase 1

Healthy | Small molecule | Other |VYNE Therapeutics Inc.|Last Updated: Sep 11, 2019

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 Trials4
Total Enrollment363
FDA Designations
No designations recorded
Clinical Trials (4)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04070755Dermal Photo Allergic Skin ReactionPHASE1 COMPLETED 56Sep 21, 2016Dec 18, 2016Aug 28, 2019 -
NCT04052711A Randomized, Controlled Study to Evaluate the Sensitizing Potential of FMX-101 in Healthy Volunteers Using a Repeat Insult Patch Test DesignPHASE1 COMPLETED 233Sep 8, 2016Dec 19, 2016Aug 21, 2019 -
NCT04064125Dermal Cumulative Irritant Patch StudyPHASE1 COMPLETED 42Sep 1, 2016Oct 28, 2016Aug 28, 2019 -
NCT04070742Dermal Phototoxicity StudyPHASE1 COMPLETED 32Aug 17, 2016Oct 1, 2016Sep 11, 2019 -
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Study Endpoints
Primary Endpoints
Assessment of photoallergic skin reactions (numerical equivalent scoring of erythema and edema) after periodic exposure to IP on irradiated and non-irradiated skin
6 weeks
Assessment of recurrence of a cutaneous response at Rechallenge equivalent to or more severe than that observed at Challenge.
8 weeks
Comparison of mean cumulative irritation over time for IP versus controls using a dermal irritation numerical equivalent grading tool.
3 weeks
Comparison between Test and Vehicle sites of the post-irradiation erythema severity at 96 hours post-application using a dermal response numerical equivalent score
4 days
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
FMX-101EXPERIMENTAL -
Interventions
NameTypeDescription
FMX-101DRUG -
FMX101DRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersYes

Inclusion Criteria: * Healthy male or female who were 18 years of age or older * Had uniformly-colored skin on the lower thoracic area of the back which allowed discernment of erythema, and were Fitzpatrick Skin Types I, II or III Exclusion Criteria: * Had any visible skin disease at the applicat...

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