Sol-gel Technologies Ltd. · NASDAQ:SLGL
Sol-gel Technologies — Technical Presentation (July 2019)
18 slides from Sol-gel Technologies's technical presentation, Jul 8, 2019
Slide 1: Epsolay Phase 3 Results
PY By Sol-Gel EPSOLAY® PHASE 3 Ria
Slide 2: Forward-looking statements
Forward-looking statements This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts are forward-looking statements. In some cases, you can identify forward-looking statem
Slide 3: Epsolay Phase 3 Study Design
EPSOLAY® PHASE 3 STUDY DESIGN Multicenter, parallel, double-blind, randomized, vehicle-controlled, 2:1 ratio, QDInclusion criteria:Male & female ≥ 18 years of age IGA score “moderate” to “severe”≥ 15 ≤ 70 inflammatory lesions≤ 2 nodules IGA Definition:“Clear”: Skin clear of inflammatory papules or p
Slide 4: Study Population & Discontinuation
STUDY POPULATION & DISCONTINUATION Study 54-02 Study 54-01 # of Patients Epsolay® Vehicle # of Patients
Slide 5: Patient Severity at Baseline
PATIENT SEVERITY AT BASELINE Study 54-01 Characteristic Epsolay® Vehicle IGA “Moderate”IGA “Severe” 210 (86.4%)33 (13.6%) 104 (88.1%)14 (11.9%) Mean lesion count (SD)Median lesion count (range) 25.7 (11.07)22.0 (15-69) 26.3 (12.45)21.0 (15-70) Study 54-02 Epsolay® Vehicle 227 (90.8%)23 (9.2%) 112 (9
Slide 6: Primary Endpoints (ITT)
PRIMARY ENDPOINTS (ITT) Study 54-02 Study 54-01 P-value < 0.001 P-value < 0.001 Success in IGA @ Week 12 Inflammatory Lesion Count Change from Baseline @ Week 12 P-value < 0.001 P-value < 0.001 Study 54-02 Study 54-01
Slide 7: Secondary Endpoint (ITT)
SECONDARY ENDPOINT (ITT) Study 54-02 Study 54-01 Inflammatory Lesion Percent Change from Baseline @ Week 12 P-value < 0.001 P-value < 0.001
Slide 8: Exploratory Endpoints (ITT)
EXPLORATORY ENDPOINTS (ITT) Study 54-02 Study 54-01 Success in IGA @ Week 2 Inflammatory Lesion Count Change from Baseline @ Week 2 P-value = 0.009 P-value = 0.017 P-value < 0.001 P-value < 0.001 Study 54-02 Study 54-01
Slide 9: Secondary Endpoints (ITT) Week 4
Success in IGA @ Week 4 Inflammatory Lesion Count Change from Baseline @ Week 4 P-value < 0.001 P-value = 0.009 P-value < 0.001 P-value < 0.001 SECONDARY ENDPOINTS (ITT) Study 54-02 Study 54-01 Study 54-02 Study 54-01
Slide 10: Secondary Endpoints (ITT) Week 8
SECONDARY ENDPOINTS (ITT) Success in IGA @ Week 8 Inflammatory Lesion Count Change from Baseline @ Week 8 P-value < 0.001 P-value = 0.006 P-value < 0.001 P-value < 0.001 Study 54-02 Study 54-01 Study 54-02 Study 54-01
Slide 11: Absolute Reduction in Lesion Count Over Time
ABSOLUTE REDUCTION IN LESION COUNT OVER TIME Statistical significant improvement in reducing inflammatory lesions as of Week 2 P-value < 0.001 P-value < 0.001
Slide 12: Success in IGA Over Time (ITT)
SUCCESS IN IGA OVER TIME (ITT) Statistical significant improvement in in getting patients to the stage of “clear” or “almost clear” P-value < 0.001 P-value < 0.001
Slide 13: Rapid efficacy of Epsolay vs Historical Soolantra Results
Rapid efficacy of Epsolay® (†) Sol-Gel did not conduct a head-to-head comparison trial or study. The results described above are for illustrative purposes only and should not be construed as conclusions to be drawn as if we conducted a head-to-head comparison trial or study SIDE-BY-SIDE WITH HISTORI
Slide 14: Side-by-Side with Other Historical Trial Results
Baseline Characteristics of Active Arm IGA Severe 33 23 82 113 26 65 0 51 71 Moderate 210 227 369 346 172 418 557 444 443 Mild 0 0 0 0 0 0 0 0 0 Inflammatory Lesions 25.7 29.8 31.0 33.3 21.6 21.7 18.3 28.5 30.0 Inflammatory Lesions – Mean Percent Change from Baseline @ Week 12 SIDE-BY-SIDE WITH OTHE
Slide 15: Lesion Count Improvement Over Time
LESION COUNT IMPROVEMENT OVER TIME
Slide 16: Skin Tolerability (Safety Population)
SKIN TOLERABILITY (SAFETY POPULATION) Study 54-01 Study 54-02 Itching Burning/Stinging Dryness Scaling Percent of Patients Epsolay® Vehicle Percent of Patients Itching Burning/Stinging Dryness Scaling
Slide 17: Treatment-Emergent Adverse Events (Safety Population)
No. (%) of Subjects Study 54-01 Epsolay® Vehicle Subjects reporting any TEAE 49 (20.5%) 17 (15.0%) Serious TEAE 1 (0.4%)1 Severe TEAE 2 (0.8%) Discontinuation 5 (2.1%) 1 (0.9%) Treatment-related 14 (5.9%) 3 (2.7%) Study 54-02 Epsolay® Vehicle 50 (20.2%) 22 (18.2%) 1 (0.4%)2 2 (0.8%)3 4 (1.6%) 1 (0.8
Slide 18: NASDAQ: SLGL www.sol-gel.com
NASDAQ: SLGLwww.sol-gel.com
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