Minerva Neurosciences, Inc · NASDAQ:NERV
Minerva Neurosciences — Corporate Update (April 2022)
17 slides from Minerva Neurosciences's corporate update, Apr 13, 2022
Slide 1: Roluperidone Update Webcast
Roluperidone Update Webcast: Wednesday, April 13, 2022, at 11:00 ET To participate, please dial (877) 312-5845 (domestic) or (765) 507-2618 (international) and refer to conference ID 2489714. The live webcast can be accessed under “Events and Presentations” in the Investors and Media section of Mine
Slide 2: Disclaimer
Disclaimer 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’s expectations as of the d
Slide 3: Participants
Participants Philip D. Harvey, PhD Dr Harvey is Leonard M. Miller Professor of Psychiatry and director of the Division of Psychology at the University of Miami Miller School of Medicine, as well as a senior Research health Scientist at the Department of Veterans Affairs. He is the author of over 1,0
Slide 4: The proposed indication
The proposed indication Minerva is developing roluperidone as a monotherapy for patients diagnosed with schizophrenia with moderate to severe negative symptoms and stable positive symptoms Why? There are no approved treatments for negative symptoms in the US We are not developing another antipsychot
Slide 5: Summary of outcomes from Type C meeting held March 2nd 2022
Summary of outcomes from Type C meeting held March 2nd 2022 Topics discussed during the meeting: Can Minerva reliably identify patients who may benefit from roluperidone as monotherapy? Does roluperidone interfere with the safety and efficacy of antipsychotics when used to treat recurrence of positi
Slide 6: Identification of patients with negative symptoms who may benefit from roluperidone in monotherapy
Identification of patients with negative symptoms who may benefit from roluperidone in monotherapy
Slide 7: Schizophrenia is a heterogeneous condition: One size therapy does not fit all
Schizophrenia is a heterogeneous condition: “One size therapy does not fit all” Schizophrenia is a heterogeneous syndrome in which some patients manifest: A single episode of psychosis Infrequent, intermittent and self-limiting episodes of psychosis while on or off antipsychotic medication Continuou
Slide 8: Can Minerva reliably identify patients who do not need antipsychotics?
Can Minerva reliably identify patients who do not need antipsychotics? In the Phase 2b and Phase 3 studies Minerva enrolled participants from a subgroup of patients with moderate to severe negative symptoms of schizophrenia who: Are readily identifiable by clinicians Have been identified and enrolle
Slide 9: This patient sub group improved in all key efficacy parameters
This patient sub group improved in all key efficacy parameters: Phase 3 Double-Blind & Open-Label Extension – Study Baseline PANSS MARDER Negative Score (NSFS) (Primary Endpoint) PSP Total Score (Key secondary endpoint) PANSS Positive Symptoms Score PANSS Total Score
Slide 10: Relapse rate in the Double-Blind Phase and Open-Label Extension
Relapse* rate in the Phase 3 Double-Blind Phase and Open-Label Extension * Relapse is defined as worsening of schizophrenia symptoms that lead to permanent discontinuation from the study Study Phase Placebo (N=172) MIN-101 32 mg (N=170) MIN-101 64 mg (N=171) Double-Blind # of Patients 8 (4.7%) 18 (1
Slide 11: Significant unmet medical need: large patient group and no approved treatments
SZ=schizophrenia. 1.Wu et al. Psychol Medicine. 2006; 2. Millier et al. J Market Acc Health Policy. 2017; 3.Haro et al. Schizophr Research. 2015; 4. Nordstroem et al. J Social Psychiatry. 2017 15%2,3 weighted-average 6-month relapse rate among patients with varying severity of negative symptoms 69%
Slide 12: Does treatment with roluperidone interfere with the safety and efficacy of antipsychotics?
Does treatment with roluperidone interfere with the safety and efficacy of antipsychotics?
Slide 13: Prospective labeling is intended to specifically exclude adjunctive treatment with antipsychotics
Prospective labeling is intended to specifically exclude adjunctive treatment with antipsychotics Roluperidone is anticipated to be prescribed only for patients who: Manifest significant negative symptoms (anhedonia, amotivation, or asociality) Absent or minimal agitation No substance use disorder S
Slide 14: Did roluperidone interfere with the efficacy of antipsychotics in Minerva's studies?
Did roluperidone interfere with the efficacy of antipsychotics in Minerva’s studies? Table 1: Median Time (Days) to Symptom Resolution by Treatment Group (Phase 2b and Phase 3) after Study Drug is Withdrawn and Patients are Treated with Antipsychotics Double-Blind Phase Parameter Placebo Roluperidon
Slide 15: Potential Route to NDA
QXMINERVA __ Potential Route to NDA
Slide 16: Minerva's plans for 2022
Minerva’s plans for 2022 Finalization of the roluperidone NDA package is estimated to be complete summer 2022, including further analyses to support topics discussed with FDA; Demonstrate that patients who would benefit from roluperidone can be reliably identified and described Discuss a clear label
Slide 17: Q&A
©) MINERVA Q&A
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