Soleno Therapeutics, Inc. · NASDAQ:SLNO
Soleno Therapeutics — Technical Presentation (June 2020)
13 slides from Soleno Therapeutics's technical presentation, Jun 8, 2020
Slide 1: DESTINY PWS Top-Line Data Call
DESTINY PWS Top-Line Data Call June 8, 2020 | Soleno Therapeutics Exhibit 99.1
Slide 2: Certain Notices and Disclaimers
| © 2020 Soleno Therapeutics Certain Notices and Disclaimers Forward-Looking Statements This presentation contains forward-looking statements that are subject to many risks and uncertainties. Forward looking statements appear in a number of places throughout this presentation and include statements
Slide 3: Phase III Program Design
| © 2020 Soleno Therapeutics Phase III Program Design C601 (DESTINY PWS): Multi-center, randomized, double-blind, placebo-controlled, parallel arm study in patients with PWS (Phase III) C602: Open-label safety extension study 2-week Run-in C601 13-Week Double-blind Treatment C602 Open-label Extensio
Slide 4: C601 Demographics and Baseline Characteristics (ITT Population)
C601 Demographics and Baseline Characteristics (ITT Population) Parameter DCCR (N = 82) Placebo (N = 42) Overall (N = 124) Mean Age (years) (SD) 13.4 (6.82) 13.6 (7.37) 13.5 (6.98) Gender, n (%) Male 36 (43.9) 19 (45.2) 55 (44.4) Female 46 (56.1) 23 (54.8) 69 (55.6) Country, n (%) United Kingdom 19
Slide 5: C601 Primary Analysis – Change From Baseline in Hyperphagia to Visit 7
C601 Primary Analysis – Change From Baseline in Hyperphagia to Visit 7 | © 2020 Soleno Therapeutics DCCR (N = 82) Placebo (N = 42) LS Mean (SE) -5.94 (0.879) -4.27 (1.145) 95% CI (-7.68, -4.20) (-6.53, -2.00) LS Mean Difference [DCCR-Placebo] (SE) -1.67 (1.294) 95% CI (-4.24, 0.89) p-value 0.1983
Slide 6: Changes from Baseline in HQ-CT at Visit
Changes from Baseline in HQ-CT at Visit 7 | © 2020 Soleno Therapeutics n = 82 n = 42 n = 19 n = 42
Slide 7: Key Secondary Endpoints
Key Secondary Endpoints Endpoint p-value Clinical Global Impression of Improvement at Visit 7 (CGI-I) 0.029 Mean Change From Baseline in Body Fat Mass (DXA) 0.025 Caregiver Global Impression of Change at Visit 7 (CGI-C) 0.409 | © 2020 Soleno Therapeutics
Slide 8: C601 Changes in Body Composition
C601 Changes in Body Composition | © 2020 Soleno Therapeutics Endpoint p-value Lean Body Mass to Fat Mass Ratio 0.001 n = 42 n = 82 n = 36 n= 59 n = 36 n = 60
Slide 9: Changes in HQ-CT after Weeks of DCCR Treatment in C601 and C602
Changes in HQ-CT after 13 or 26 Weeks of DCCR Treatment in C601 and C602 | © 2020 Soleno Therapeutics
Slide 10: PWS Outcomes Assessment – Interim Analysis
PWS Outcomes Assessment – Interim Analysis “Minor” includes improvements classified as between major and minor, as well as mixed. | © 2020 Soleno Therapeutics Caregiver interviews at the end of C601 Positive improvements in all 3 domains reported for a significant proportion of DCCR patients (~48%);
Slide 11: C601 Safety Summary of Adverse Events
C601 Safety | © 2020 Soleno Therapeutics Summary of Adverse Events TEAEs in >5% of DCCR Subjects Number (%) of subjects with at least one: DCCR (N=84) n (%) Placebo (N=42) n (%) Preferred Term DCCR (N=84) n (%) Placebo (N=42) n (%) TEAE 70 (83.3) 31 (73.8) Hypertrichosis 30 (35.7) 6 (14.3) TEAE resu
Slide 12: DCCR Safety Profile
DCCR Safety Profile The safety profile of DCCR in C601 was generally consistent with the known profile of diazoxide and prior experience with DCCR. Most events were Grade 1 in severity, including all events of hypertrichosis (except one Grade 2 in the placebo group). No Grade 4 or higher events were
Slide 13: DESTINY PWS Top-Line Data Call
DESTINY PWS Top-Line Data Call June 8, 2020 | Soleno Therapeutics
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