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FMX101 vehicle

Phase 1

Acne Vulgaris | Small molecule | Dermatology |VYNE Therapeutics Inc.|Last Updated: Apr 6, 2021

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-BlindCONTROLLED
Total Trials1
Total Enrollment12
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03743038A Study Comparing Two Topicals in the Treatment of Acne VulgarisPHASE1 COMPLETED 12Nov 20, 2018Feb 11, 2019Apr 6, 20211 United States
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Study Endpoints
Primary Endpoints
Number of Participants With 0 to 4 Investigator's Global Assessment Score at Week 6
At Week 6

Severity of acne vulgaris was assessed by Investigator Global Assessment (IGA). The IGA score is a static evaluation of the overall severity or "average" degree of severity of a participant's disease by the Blinded Evaluator taking into account all of the participant's facial acne lesions as the participant appears on the day of the evaluation. Overall severity of acne was assessed using a five-point scale where 0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate, and 4=Severe. Low score represented best outcome and higher score value indicated worst outcome.

Number of Participants Achieving Investigator's Global Assessments Treatment Success at Week 6
At Week 6

Severity of acne vulgaris was assessed by IGA. The IGA score is a static evaluation of the overall severity or "average" degree of severity of a participant's disease by the Blinded Evaluator taking into account all of the participant's facial acne lesions as the participant appears on the day of the evaluation. Overall severity of acne was assessed using a five-point scale where 0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate, and 4=Severe. The IGA treatment "success" was defined as at least a two-point improvement in IGA score relative to Baseline.

Absolute Change From Baseline to Week 6 in Inflammatory Lesion Count
Day 1/ Baseline and Week 6

Inflammatory lesion count (ILC) included papules (raised inflammatory lesions with no visible purulent material) and pustules (raised inflammatory lesions with visible purulent material).

Percentage Change From Baseline to Week 6 in Inflammatory Lesion Count
Day 1/ Baseline and Week 6

The ILC included papules (raised inflammatory lesions with no visible purulent material) and pustules (raised inflammatory lesions with visible purulent material).

Absolute Change From Baseline to Week 6 in Non-Inflammatory Lesion Count
Day 1/ Baseline and Week 6

The non-inflammatory lesion count (NILC) included open and closed comedones.

Percentage Change From Baseline to Week 6 in Non-Inflammatory Lesion Count
Day 1/ Baseline and Week 6

The NILC included open and closed comedones.

Change in Sebum Percentage Relative to Baseline Versus Weeks 2, 4, 6 and 7
Day 1/Baseline and Weeks 2, 4, 6 and 7

Sebum measurement was conducted on the right and left side of the face. The sebum measurement represented the sebum score of saturation of the film and had a range of 0 to 99, where 99 equated to very oily skin.

Change in Transepidermal Water Loss Relative to Baseline Versus Weeks 2, 4, 6 and 7
Day 1/Baseline and Weeks 2, 4, 6 and 7

Transepidermal Water Loss (TEWL) was conducted on the right and left side of the face.

Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
Day 1 until Week 7 (End of Study) and Unscheduled Visit

An adverse event is any untoward medical occurrence associated with the use of a drug in participants, whether or not considered drug related.

Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline
Day 1 until Week 7 (End of Study) or Unscheduled Visit

The local skin reactions (LSRs) included erythema, edema, scaling/dryness, burning/stinging, pruritus, erosion, and pain) were assessed. Erythema, edema, scaling/dryness, and erosion were assessed by the investigator and burning/stinging, pain, and pruritus were assessed by the participant. Assessments was made using a 4-point ordinal scale where 0=absent, 1=mild (slight, barely perceptible), 2=moderate (distinct presence), and 3=severe (marked, intense). Here, lower point represented no reaction and higher points represented severe reactions.The LSRs were assessed both before and 15 minutes following test article application.

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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
FMX101 vehicleEXPERIMENTALFMX101 hydrophobic oil based vehicle (Test Article A) topically applied daily for six weeks on one side of the face (in a split-face model)
Hydro-alcohol solution baseEXPERIMENTALHydro-alcohol solution based vehicle (Test Article B) topically applied daily for six weeks on the contralateral side of the face (in a split-face model)
Interventions
NameTypeDescription
FMX101 vehicleDRUGFMX101 vehicle - hydrophobic oil based vehicle (Test Article A)
Hydro-alcohol solutionOTHERHydro-alcohol solution based vehicle (Test Article B)
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Eligibility Criteria
Age Range12 Years — 40 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Has facial acne vulgaris with: 16 inflammatory lesions (papules, pustules) The inflammatory lesion count on the right and left side of the face should be similar IGA score of moderate (3) on both the right and left side of the face Exclusion Criteria: * Acne conglobata, a...

Countries:United States
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