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S6G5T-3

Phase 3

Acne Vulgaris | Small molecule | Dermatology |Sol-Gel Technologies Ltd.|Last Updated: Dec 16, 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-BlindACTIVE_CONTROLLEDBiomarker
Total Trials4
Total Enrollment1,646
FDA Designations
No designations recorded
Clinical Trials (4)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03761784A Study of S6G5T-3 in the Treatment of Acne VulgarisPHASE3 COMPLETED 424Dec 21, 2018Dec 31, 2019Dec 16, 20211 United States
NCT03761810A Study of S6G5T3 in the Treatment of Acne VulgarisPHASE3 COMPLETED 434Dec 14, 2018Oct 23, 2019Dec 16, 20211 United States
NCT02661958Efficacy, Safety, and Tolerability of S6G5T-1 and S6G5T-3 for the Treatment of Acne VulgarisPHASE2 COMPLETED 726May 1, 2016Oct 1, 2017Sep 19, 201934 United States
NCT04059523MUSE Study to Evaluate the Pharmacokinetics, Safety and Tolerability of S6G5T-3PHASE1 COMPLETED 62Jun 27, 2019Feb 6, 2020Mar 18, 20202 United States
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Study Endpoints
Primary Endpoints
Percentage of Participants Achieving an IGA Score of Clear or Almost Clear and a Score ≥2 Grades Less Than Baseline
Baseline through Week 12

Percentage of participants in each treatment group achieving an acne severity IGA score of "clear (score=0)" or "almost clear (score=1)" and achieving an acne severity IGA score of at least 2 grades less than Baseline.

Change From Baseline in Inflammatory Lesion Counts on the Face at Week 12
Baseline, Week 12

Inflammatory lesions were characterized by papules, pustules, nodules, and cysts. Least squares means and standard deviations from an analysis of covariance (ANCOVA) with factors of treatment group and analysis center and the respective Baseline lesion count as a covariate. For the inflammatory lesion count analysis, the interaction of treatment by analysis center was included in the model based on the conclusion from the pooling analysis. Negative least squares means values represent decrease from Baseline.

Change From Baseline in Non-Inflammatory Lesion Counts on the Face at Week 12
Baseline, Week 12

Non-inflammatory lesions were characterized by open comedones (blackheads) and closed comedones (whiteheads). Least squares means and standard deviations from an ANCOVA with factors of treatment group and analysis center and the respective Baseline lesion count as a covariate. Negative least squares means values represent decrease from Baseline.

Investigator's Global Assessment (IGA)
week 12

Proportion of subjects with an assessment of clear or almost clear with at least a 2-grade improvement in IGA at Week 12

Absolute change in lesion count (separately for inflammatory and non-inflammatory)
baseline and week 12

Absolute change from Baseline in lesion count on the face at Week 12 (separately for inflammatory and non-inflammatory lesions)

Pharmacokinetics of S6G5T-3 as measured by the maximum observed plasma concentration
14 days

The degree of systemic exposure of S6G5T-3 compared to the Reference Listed Drug (RLD) when applied topically once daily for 14 days, under maximal use conditions in subjects with acne vulgaris. Cmax = Maximum plasma concentration will be calculated

Secondary Endpoints
Percent Change From Baseline in Non-Inflammatory Lesion Counts on the Face at Week 12
Baseline, Week 12
Percent Change From Baseline in Inflammatory Lesion Counts on the Face at Week 12
Baseline, Week 12
Percentage of Participants Achieving at Least a 4-Point Reduction on Item 1 (Pimple) of the Patient-Reported Evaluation of Facial Acne (Pre-Face)
Baseline and Week 12
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
S6G5T-3EXPERIMENTALParticipants will topically apply S6G5T-3 cream, once daily to face for 12 weeks.
S6G5T-8 Vehicle CreamPLACEBO_COMPARATORParticipants will topically apply S6G5T-8 vehicle cream, once daily to face for 12 weeks.
S6G5T-1EXPERIMENTALtopical cream
S6G5T-5ACTIVE_COMPARATORtopical cream
S6G5T-7ACTIVE_COMPARATORtopical cream
S6G5T-6ACTIVE_COMPARATORtopical cream
S6G5T-8PLACEBO_COMPARATORtopical cream
Retin-A® 0.1% CreamACTIVE_COMPARATORtopical cream
Interventions
NameTypeDescription
S6G5T-3DRUGOnce a day topical cream
S6G5T-8DRUGOnce a day topical cream
S6G5T-1DRUGonce a day topical cream
S6G5T-5DRUGonce a day topical cream
S6G5T-6DRUGonce a day topical cream
S6G5T-7DRUGonce a day topical cream
Retin-A® 0.1% CreamDRUGonce daily
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Eligibility Criteria
Age Range9 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Participant must sign an Institutional Review Board (IRB) approved written informed consent for this study. 2. Male and female 9 years of age and older. 3. Have 2 or fewer cysts or nodules. Exclusion Criteria: 1. More than 2 acne nodules or cysts (defined as an inflammatory...

Countries:United States
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