Minerva Neurosciences, Inc · NASDAQ:NERV
Minerva Neurosciences — Corporate Update (May 2017)
9 slides from Minerva Neurosciences's corporate update, May 15, 2017
Slide 1: MIN-101 Development Update Post EOP2 Meeting with FDA
MIN-101 DEVELOPMENT UPDATE POST EOP2 MEETING WITH FDA May 16, 2017 Nasdaq: NERV Exhibit 99.3
Slide 2: Forward-looking statements
This presentation contains forward-looking statements about Minerva Neurosciences 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’s expecta
Slide 3: Phase 3 efficacy study: confirmatory study design (1)
Phase 3 efficacy study: confirmatory study design (1) 3 months double-blind + 9 months open-label ~500 patients randomized 1:1:1 to two doses of MIN-101 vs placebo, mono-therapy Symptomatically stable patients for several months with moderate to severe negative symptoms (>20 PANSS negative), mild po
Slide 4: Phase 3 efficacy study: confirmatory study design (2)
Phase 3 efficacy study: confirmatory study design (2) Primary outcome Marder cluster of negative symptoms (N1, N2, N3, N4, N6, G7, G16) Secondary outcomes CGI and PSP together with G16 will highlight effect on social functioning ~1/3 of the patients to be recruited in the US, with the remainder from
Slide 5: Phase 3 efficacy study: Safety and tolerability aspects
Phase 3 efficacy study: Safety and tolerability aspects Vital signs ECGs (triplicate; centralized reading) Regular lab testing including prolactin Pharmacokinetics samples for MIN-101 levels & un-allowed treatments
Slide 6: Key activities in parallel to efficacy study
Phase 3: Key activities in parallel to efficacy study Standard clinpharm studies for NDA, including: DDI studies tQt study Population at risk (renal impaired patients) Complete carcinogenicity package CMC package Toxicological package completion* * 6 and 9 months toxicological package completed
Slide 7: Other strategic considerations (1): Pediatric plan
Other strategic considerations (1): Pediatric plan Conduct trial in Ultra High Risk adolescents (premorbid schizophrenia, early onset schizophrenia) large population predominant manifestation of negative symptoms poor benefit/risk ratio of antipsychotics and major ethical dilemma few subjects progre
Slide 8: Other strategic considerations (2): Phase 4, additional trials in schizophrenia
Other strategic considerations (2): Phase 4, additional trials in schizophrenia Relapse prevention trials in non-acutely exacerbated patients Demonstrate better tolerability and improved patient satisfaction No EPS and no metabolic AE compared to D2 blocker hence potential for better compliance lowe
Slide 9: Other strategic considerations (3): Phase 3 trials in additional indications
Other strategic considerations (3): Phase 4 trials in additional indications Schizophrenia spectrum disorder and DSM-5 recognized diagnostic category of socially and vocationally impaired individuals with considerable negative symptoms and no current Rx available Apathy and avolition in brain degene