Sol-gel Technologies Ltd. · NASDAQ:SLGL
Sol-gel Technologies — Technical Presentation (January 2020)
23 slides from Sol-gel Technologies's technical presentation, Jan 8, 2020
Slide 1: Twyneo Phase 3 Results
S Sol 6el TWYNEO®* PHASE 3 RESULTS
Slide 2: 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 statements by terms such as “may,
Slide 3: Acne vulgaris and the Twyneo solution
A multifactorial disease of the pilosebaceous unit, involving abnormalities in sebum production, follicular epithelial desquamation, bacterial proliferation, and inflammation Topical BPO, retinoids, antibiotics, and their combinations; isotretinoin and antibiotics are mainstays of systemic therapy I
Slide 4: Twyneo Phase 3 study design
Co-Primary EndpointsProportion of subjects with an assessment of clear or almost clear and with at least a 2-grade improvement in IGA from baseline at Week 12Absolute change in inflammatory lesion counts from baseline at Week 12Absolute change in non-inflammatory lesion counts from baseline at Week
Slide 5: Baseline demographics and disease characteristics
Study 65-04 Study 65-05 Number of sites 32 31 Twyneo®(n=281) Vehicle (n=143) Twyneo®(n=290) Vehicle (n=144) Age, yearsMean (SD)Median (range) 20.9 (8.48)18.0 (11-67) 21.4 (8.62)18.0 (10-57) 20.1 (6.96)18.0 (10-51) 20.3 (6.67)18.5 (9-42) Sex, n (%)MaleFemale 106 (37.7%)175 (62.3%) 60 (42.0%)83 (58.0%
Slide 6: Low discontinuation rate across studies
Low discontinuation rate across studies Study 65-04 Study 65-05 Twyneo®(n=281) Vehicle (n=143) Twyneo®(n=290) Vehicle (n=144) Randomized Subjects Discontinued 32 12 48 12 Adverse events 4 (1.4%) 0 12 (4.1%) 0 Lost to follow-up 10 (3.6%) 7 (4.9%) 15 (5.2%) 7 (4.9%) Lack of efficacy 0 0 0
Slide 7: Co-primary endpoint: IGA treatment success at Week 12
Co-primary endpoint (itt) IGA Treatment Success at Week 12 Percent of subjects achieving IGA success at Week 12 P<0.001 Study 65-04 Vehicle(n=143) Vehicle P=0.017 Study 65-05 (n=290) (n=144) (n=281)
Slide 8: Co-primary endpoint: inflammatory lesions change at Week 12
Co-primary endpoint (itt) Absolute Mean Change From Baseline in Inflammatory Lesions at Week 12 P<0.001 P=0.018 Study 65-04 Study 65-05 Mean reduction in inflammatory lesion count from baseline at Week 12 Vehicle(n=143) (n=281) (n=290) Vehicle(n=144)
Slide 9: Co-primary endpoint: non-inflammatory lesions change at Week 12
Co-primary endpoint (itt) Absolute Mean Change From Baseline in Non-Inflammatory Lesions at Week 12 Mean reduction in non-inflammatory lesion count from baseline at Week 12 Study 65-04 Study 65-05 P<0.001 P<0.001 Vehicle(n=143) Vehicle(n=144) Twyneo®(n=281) Twyneo®(n=290)
Slide 10: Success in IGA in recent acne trials
SUCCESS IN IGA IN RECENT ACNE TRIALS* Trials With Highest Difference in IGA Between the Active Arm and the Vehicle Arm *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 dr
Slide 11: Success in IGA in moderate subjects
SUCCESS IN IGA IN MODERATE Subjects* Trials With Highest Difference in IGA Between the Active Arm and the Vehicle ArmModerate Subjects at Baseline Only Percent of subjects achieving IGA success at Week 12 normalized to vehicle Twyneo® *Sol-Gel did not conduct a head-to-head comparison trial or study
Slide 12: Supportive analysis: IGA treatment success over time
Twyneo®(n=281) Supportive efficacy analysis*(itt) IGA Treatment Success Over Time Percent of subjects achieving IGA success Week Week Study 65-04 Study 65-05 *Percent of subjects with an assessment of clear or almost clear and with at least a 2-grade improvement in IGA from baseline, at Weeks 2, 4
Slide 13: Supportive analysis: lesion count reduction over time
Supportive efficacy analysis* (itt) Mean Reduction in Non-Inflammatory Lesion Count Over Time Mean change from baseline in non-inflammatory lesion count Study 65-04 Study 65-05 Week Week Mean change from baseline in inflammatory lesion count Study 65-04 Study 65-05 Week Week Mean Reduction in Inflam
Slide 14: Safety & tolerability
Safety & tolerability Nearly all AEs were mild or moderate in severityTotal of 18 subjects discontinued from Studies 65-04 and 65-05 due to a TEAE: 18 (2%) in Twyneo® and 0 in vehicle No treatment-related SAEs were identified in either study2 subjects reported SAEs in Study 65-05; (1) Twyneo® subjec
Slide 15: Local skin tolerability assessment at week 12
Local Skin Tolerability assessment* at week 12 *Safety population Study 65-04 Study 65-05
Slide 16: Local skin tolerability assessments over time
Local skin tolerability assessments over time Safety population for Study 65-04 (n=274). Safety population for Study 65-04 (n=281). BL=baseline; 12W=12 weeks Erythema Scaling Pigmentation Dryness Itching Burning Stinging Percent of subjects BL 12W BL 12W BL 12W BL 12W BL 12W BL 12W BL 12W BL 12W BL
Slide 17: Twyneo Phase 3 results summary
Twyneo® phase 3 results Successfully met all primary efficacy endpoints demonstrating statistically significant improvements over vehicleNo treatment-related seriousadverse events Well-tolerated, with results similarto vehicle at 12 weeks
Slide 18: Introducing Hilary Baldwin, MD
Introducing Hilary baldwin, MD Past President of the American Acne and Rosacea Society, Clinical Associate Professor of Dermatology at Rutgers Robert Wood Johnson School of Medicine, and Director of the Acne Treatment and Research Center.
Slide 19: Twyneo IGA treatment success and lesion reduction: patient example
TWYNEO® IGA treatment success and significantreduction in Inflammatory Lesion Count TEAE definition: Subject: 417-004. Age: 19 years old. Gender: Male. Race: Hispanic or Latino, white Week 12 Baseline
Slide 20: Twyneo IGA treatment success and lesion reduction: patient example
TEAE definition: Subject: 518-010. Age: 18 years old. Gender: Female. Race: Hispanic or Latino, white Week 12 Baseline TWYNEO® IGA treatment success and significantreduction in Inflammatory Lesion Count
Slide 21: Per-protocol failure in IGA, success in lesion reduction
TEAE definition: Subject: 507-003. Age: 18 years old. Gender: Female. Race: Hispanic or Latino, white TWYNEO® Per-Protocol “Failure” in IGA and Success in Inflammatory Lesion Count Reduction Week 12 Baseline
Slide 22: Per-protocol failure in IGA, success in lesion reduction
TWYNEO® Per-Protocol “Failure” in IGA and Success in Inflammatory Lesion Count Reduction TEAE definition: Subject: 501-015. Age: 16 years old. Gender: Male. Race: Hispanic or Latino, white Week 12 Baseline
Slide 23: Questions
34 QUESTIONS
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