Minerva Neurosciences, Inc · NASDAQ:NERV
Minerva Neurosciences — Technical Presentation (June 2020)
26 slides from Minerva Neurosciences's technical presentation, Jun 5, 2020
Slide 1: Roluperidone: Topline results from the Phase 3 trial
ROLUPERIDONE: Topline results from the Phase 3 trial: A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-Controlled, Monotherapy, 12-Week Study to Evaluate the Efficacy and Safety of 2 Fixed Doses of MIN-101 in Adult Patients with Negative Symptoms of Schizophrenia, Followed by 40-Week
Slide 2: Forward-Looking Statement Safe-Harbor
Forward-Looking Statement Safe-Harbor This presentation contains forward-looking statements which are subject to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts, reflect management
Slide 3: Webcast Agenda: Roluperidone Phase 3 Top-Line Results
Webcast Agenda: Roluperidone phase 3 Top-Line Results (TLR) Topic Assigned Introductions William Boni, VP IR Study Results Remy Luthringer, PhD, Chairman & CEO Results Discussion by KOL’s Phil Harvey, PhD Brian Kirkpatrick, MD Concluding remarks & next steps Remy Luthringer Q&A Michael Davidson, MD,
Slide 4: Study Design Schema & Key Study Elements
Study Design Schema & Key Study Elements
Slide 5: Phase 3: Study Design Schema and Key Study Elements
4-week screening phase including washout (Day -28 to Day -1) 12-week double-blind treatment phase (Day 1 to Week 12) 40-week open-label extension phase (Week 12 to Week 52) Placebo PO, QD MIN-101 32 mg PO, QD MIN-101 64 mg PO, QD Randomization Primary Analysis Crossover Phase 3: Study Design Schema
Slide 6: Patient Population, Procedures & Statistical Method
Phase 3 : Patient Population, Procedures & Statistical Method DSM-5 schizophrenia for at least 1 year Baseline score > 20 on the 7 items PANSS negative score 18 to 55 years of age Outpatient, symptomatically stable and manifesting negative symptoms for 6 months Withdrawn from depot antipsychotics fo
Slide 7: Disposition
Disposition O MINERVA
Slide 8: Phase 3: Disposition Flow Chart
Phase 3: Disposition Flow Chart 857 Patients screened 342 Patients screen failed Randomized (n=515) Safety population (n=513) ITT population (n=513) Per Protocol population (n=359) MIN-101 64 mg Safety population, n=171 ITT population, n=171 Per-protocol population, n=120 MIN-101 32 mg Safety popula
Slide 9: Primary Endpoint
Primary Endpoint O MINERVA
Slide 10: Phase 3: Marder's Negative Symptom Factor Score – Primary Endpoint
Phase 3: Marder’s Negative Symptom Factor Score – Primary Endpoint
Slide 11: Marder's Negative Symptom Factor Score by Study: Phase 2b & Phase 3
Phase 2b NSFS Phase 3 NSFS Factor Phase 2b Phase 3 Age at Baseline (yrs) 40 41 PANSS NS Subscore 27 27 PANSS Total Score 80 79 Placebo delta in PANSS NSFS (primary) 1.6 3.5 64 mg delta in PANSS NSFS (primary) 3.9 4.3 Marder’s Negative Symptom Factor Score by Study - comparison of Phase 2b & Phase 3
Slide 12: Phase 3: NSFS & Negative Symptom Dimensions
Phase 3: NSFS & Negative Symptom Dimensions1 1 Roluperidone demonstrated statistically significant superiority to placebo in improving emotional experience and emotional expression: Harvey et al., 2020; Schizophrenia Research
Slide 13: Phase 3: PANSS Negative Symptom Subscore
Phase 3: PANSS Negative Symptom Subscore – Sum of the 7 “N” items
Slide 14: Responder Analysis: PANSS Total & Marder NSFS
Responder Analysis: PANSS Total & Marder Negative Symptoms Factor Score (NSFS)
Slide 15: Phase 3: Responder Analysis of PANSS Total and Marder NSFS
Phase 3: Responder Analysis of PANSS Total and Marder Negative Symptoms Factor Score (NSFS)
Slide 16: Preliminary Primary Endpoint Integrated Analysis
Preliminary Primary Endpoint Integrated Analysis
Slide 17: Primary Endpoint Integrated Analysis: Phase 2b & Phase 3
Primary Endpoint Integrated Analysis: Marder’s Negative Symptom Factor Score from Phase 2b & Phase 3 Studies – Preliminary Results ES=0.37; ES=0.26
Slide 18: Key Secondary Endpoint
Key Secondary Endpoint O MINERVA
Slide 19: Phase 3: Personal and Social Performance Total Score
Phase 3: Personal and Social Performance Total Score – Key Secondary Endpoint
Slide 20: Efficacy Summary
Efficacy Summary O MINERVA
Slide 21: Phase 3: Summary of Efficacy Findings
Phase 3: Summary of Efficacy Findings
Slide 22: Phase 3: Summary Key Findings
Phase 3: Summary Key findings: Patient populations in the phase 2b and phase 3 are comparable Improvement of negative symptoms as measured by NSFS are similar in both studies Both doses show early separation from placebo at week 4 (both doses) and week 8 (64mg) Due to higher placebo response, rolupe
Slide 23: Results Discussion by KOL's Phil Harvey & Brian Kirkpatrick
RESULTS DISCUSSION BY KOL’S Phil Harvey & Brian Kirkpatrick
Slide 24: Concluding Remarks & Next Steps
CONCLUDING REMARKS & NEXT STEPS Remy Luthringer
Slide 25: Roluperidone (MIN-101) – Concluding Remarks & Next Steps
Roluperidone (MIN-101) – CONCLUDING REMARKS & NEXT STEPS Further data analyses will continue over the coming weeks: Complete understanding of the data Further explore placebo group and understand the difference seen between the phase 2b and 3 study To continue our dialogue with our regulatory adviso
Slide 26: Q&A
Q&A Michael Davidson Phil Harvey Brian Kirkpatrick Remy Luthringer Geoff Race Rick Russell Jay Saoud
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