Sienna Biopharmaceuticals Inc · OTC:SNNAQ
Sienna Biopharmaceuticals — Technical Presentation (December 2018)
14 slides from Sienna Biopharmaceuticals's technical presentation, Dec 3, 2018
Slide 1: SNA-120 Phase 2b Trial Top-Line Results
SNA-120 Phase 2b Trial Top-Line Results December 3, 2018 March 2017 Exhibit 99.2
Slide 2: Forward Looking Statements
Forward Looking Statements This presentation contains forward-looking statements. All statements other than descriptions of historical facts contained in this presentation, including statements regarding future operational and financial results and positions, business strategy, prospective products,
Slide 3: Agenda
Agenda SNA-120 Phase 2b Executive Summary Study Design Demographics Top-Line Results Primary Endpoint Key Secondary Endpoints Safety and Tolerability Q&A Topical by Design™ Mechanism of Action of SNA-120
Slide 4: SNA-120 Phase 2b Trial Executive Summary
These data were not entirely as we would have expected We began this study with data suggesting we had a pruritus drug with a positive impact on psoriasis We now have data indicating we have a potential psoriasis drug with a positive impact on pruritus We had a substantial 58% reduction on itch in t
Slide 5: Executive Summary (cont'd)
We now have data in 500+ subjects treated with SNA-120, demonstrating that it is well tolerated and has an acceptable safety profile, and further validating our Topical by Design™ platform We intend to have an End-of-Phase 2 meeting with the FDA and then begin Phase 3 trials for psoriasis in 2H19 We
Slide 6: SNA-120 Phase 2b Study Design
Multicenter, randomized, double-blind, Vehicle-controlled study Enrolled 208 subjects over the age of 18 with mild-to-moderate psoriasis and at least moderate itch Treated each subject twice daily for 12 weeks with either SNA-120 (0.05% or 0.5% ointment) or Vehicle Primary endpoint: Change in previo
Slide 7: Important Changes from Previous Phase 2b Study
Refined population in this study: Included only itchy subjects with at least moderate itch (> 5 on the I-NRS) Excluded severe psoriasis subjects Longer treatment duration: 12 weeks (instead of 8 weeks) Only two SNA-120 doses: High (0.5%) and low (0.05%) concentrations from previous study I-NRS daily
Slide 8: Demographics
Characteristic SNA-120 (0.05%) n=70 SNA-120 (0.5%) n=69 Vehicle n=69 Age (years) mean (SD1) 49.5 (15.3) 53.8 (13.4) 49.7 (14.5) Male, n (%) 35 (50.0) 34 (49.3) 29 (42.0) Race, n (%) Asian Black/African American White Other 3 (4.3) 4 (5.7) 59 (84.3) 4 (5.7) 4 (5.8) 4 (5.8) 59 (85.5) 2 (2.8) 4 (5.8) 1
Slide 9: Primary Endpoint: Reduction in mean I-NRS not differentiated from vehicle
Treatment Group Baseline Week 1 Week 8 (Primary) Week 12 (EoT1) SNA-120 (0.05%) Mean (SD) CFB2 (SD) p value vs Vehicle 7.3 (1.31) 5.7 (1.53) -1.6 (1.51) p=0.212 3.0 (1.96) -4.3 (2.41) p=0.244 2.6 (2.10) -4.6 (2.44) p=0.231 SNA-120 (0.5%) Mean (SD) CFB (SD) p value vs Vehicle 7.4 (1.24) 5.8 (1.63) -1
Slide 10: Secondary Endpoints: PASI 50 and PASI 75
Treatment Group Week 8 Week 12 PASI 50 SNA-120 (0.05%) proportion of subjects p value vs Vehicle 30 (49.2%) p=0.130 32 (54.2%) p=0.057 SNA-120 (0.5%) proportion of subjects p value vs Vehicle 20 (31.7%) p=0.636 25 (41.7%) p=0.562 Vehicle proportion of subjects 23 (35.9%) 22 (36.7%) PASI 75 SNA-120 (
Slide 11: Secondary Endpoint: IGA
Treatment Group Week 8 Week 12 IGA ≥ 2-grade and ‘Clear’/‘Almost Clear’ SNA-120 (0.05%) proportion of subjects p value vs Vehicle 10 (16.4%) p=0.518 17 (28.8%) p=0.036* SNA-120 (0.5%) proportion of subjects p value vs Vehicle 2 (3.2%) p=0.053 3 (5.0%) p=0.119 Vehicle proportion of subjects 8 (12.5%)
Slide 12: SNA-120 was well-tolerated with no serious treatment-related AEs
Treatment-related AEs were observed in only 2 subjects and included dermatitis (0.5% group) and pain and pruritus (Vehicle group) Most common AEs (≥ 2 subjects) in any group were nasopharyngitis, nausea, diarrhea, cellulitis and urinary tract infection Majority of TEAEs2 were mild to moderate There
Slide 13: Large Market Opportunity for SNA-120 in United States
7.5 million Total psoriasis patient population1 6.0 million Mild-to moderate psoriasis patients1 $500-$950/month Price range for 60-gram tube of current topical psoriasis therapies3 American Academy of Dermatology. Skin conditions by the numbers. Accessed November 2018. Pruritus in Chronic Plaque Ps
Slide 14: Pipeline and Anticipated Milestones
Regulated as a drug pursuant to a new drug application (NDA) regulatory pathway Regulated as a Class II medical device under 510(k) marketing clearance pathway TrkA = tropomyosin receptor kinase A JAK3 = Janus kinase 3 Top-line acne data for 1064 nm and 810 nm did not show statistical significance o
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