Minerva Neurosciences, Inc · NASDAQ:NERV
Minerva Neurosciences — Technical Presentation (April 2020)
23 slides from Minerva Neurosciences's technical presentation, Apr 1, 2020
Slide 1: Roluperidone: A potential novel mechanism to treat the negative symptoms of schizophrenia
Roluperidone: A potential novel mechanism to treat the negative symptoms of schizophrenia William Carpenter MD John Kane MD Steven Marder MD Ofer Agid MD Remy Luthringer PhD Hosted by Minerva Neurosciences (Nasdaq: NERV) Tuesday, March 31, 2020 Exhibit 99.1
Slide 2: Forward-Looking Statement Safe-Harbor
All trademarks, trade names and service marks appearing in this presentation are the property of their respective owners. Forward-Looking Statement Safe-Harbor This presentation contains forward-looking statements about Minerva Neurosciences which are subject to the safe harbor provisions of the Pri
Slide 3: Agenda
Agenda KOL discussion of the frequently asked questions about negative symptoms Roluperidone: an update
Slide 4: Input from KOLs about the frequently asked questions regarding negative symptoms
William Carpenter MD John Kane MD Steven Marder MD Ofer Agid MD Input from KOLs about the frequently asked questions regarding negative
Slide 5: 1: Incidence of schizophrenia with negative symptoms
Question 1: incidence of schizophrenia with negative symptoms How many patients with schizophrenia live in the US? How many are diagnosed and are getting treatment? How many have negative symptoms? How many do not have negative symptoms at all? Are there different sub-categories of patients among th
Slide 6: 2: What is the right trial design for a novel drug to treat negative symptoms?
Question 2: What is the right trial design for a novel drug to treat negative symptoms? How can we be sure we have a specific effect versus a pseudo-effect? Assuming that experienced investigators are well-trained in patient selection and use of scales, how likely it is that: Regional differences in
Slide 7: 3: Different attributes of the NS scales extracted from the PANSS scale
Question 3: Can you comment about the different attributes of the different NS scales which can be extracted from the PANSS scale? What are the specifics of the Marder score? N1. Blunted affect N2. Emotional withdrawal N3. Poor rapport N4. Passive/apathetic social withdrawal N5. Difficulty in abstra
Slide 8: 4: Understanding of Negative Symptoms and cognitive impairment
Question 4: Can you comment on our current understanding of Negative Symptoms and cognitive impairment? How are the recent publications around roluperidone helping? References: Harvey et al., 2020. Effects of Roluperidone (MIN-101) on two dimensions of the negative symptoms factor score: Reduced emo
Slide 9: 5: Do currently available drugs have a beneficial effect specific for negative symptoms?
Question 5: Do currently available drugs have a beneficial effect which is specific for negative symptoms? Has the FDA ever approved a drug specifically targeting negative symptoms? Are antidepressants effective to treat primary, deficit, negative symptoms? Reference: Fusar-Poli et al., 2014. Treatm
Slide 10: 6: Would a drug which improves function or is better tolerated enhance compliance?
Question 6: Would a drug which improves function and/or is better tolerated enhance compliance? About 2/3 of the schizophrenic patients do not adhere to medication as prescribed 1,2 Although lack of insight is often mentioned, poor response and adverse effects are the main reasons for non-adherence
Slide 11: 7: Current landscape of drugs under development for negative symptoms
Question 7: What is the current landscape of drugs under development for negative symptoms? How do you see the future research directions? “With myriad programs expecting near-term readouts and what we view as a favorable regulatory body for drug approvals in the mood disorder space, drug developmen
Slide 12: 8: How will roluperidone be prescribed in clinical practice?
Question 8: How will roluperidone be prescribed in clinical practice? Can doses of anti-psychotics be reduced or even stopped in some sub-groups of patients? Reference: Huhn M et al., 2020. Reducing antipsychotic drugs in stable patients with chronic schizophrenia or schizoaffective disorders: a ran
Slide 13: 9: Can treatment of negative symptoms benefit at-risk youngsters?
Question 9: Can Rx of negative symptoms benefit “at risk” youngsters and affect the rate of transition to schizophrenia ? Would first episode patients also benefit? References: Yung et al., 2019. Persistent negative symptoms in individuals at Ultra High Risk for psychosis. Schizophrenia Res. Addingt
Slide 14: 10: Do Negative Symptoms manifest beyond schizophrenia?
Question 10: Do Negative Symptoms manifest beyond schizophrenia? Are they comparable to the one seen in schizophrenia? 1.Schizophrenia 2. Schizoaffective Disorder 3. Schizophreniform Disorder 4. Schizotypal Personality Disorder 5. Schizoid Personality Disorder 6. Paranoid Personality Disorder 7. Avo
Slide 15: Roluperidone: An update
Roluperidone: An update Remy Luthringer PhD CEO & Executive Chairman Minerva Neurosciences
Slide 16: Roluperidone (MIN-101 C07): Pivotal phase 3 study design
Roluperidone (MIN-101 C07): Pivotal phase 3 study to evaluate efficacy and safety in 515 schizophrenic patients with negative symptoms 4 week screening phase including washout (day -28 to day -1) 12 week double-blind treatment phase (day 1 to day 84) 40 week open label extension phase (day 85 to day
Slide 17: Roluperidone Pivotal Phase 3 trial update
Enrollment completed – 515 patients randomized On track to report topline results from the 12-week, double-blind portion of the study in the second quarter of 2020 COVID-19 update: As the situation is continuously evolving, we are, with our CRO, in constant contact with the clinical sites to identif
Slide 18: Results of the Phase 2b trial
We observed a significant effect on depression, and a significant effect on negative symptoms is maintained after controlling for Calgary depression scores. Roluperidone demonstrated a statistically significant reduction in negative symptoms and total PANSS score: Results of the Phase 2b trial Sourc
Slide 19: Overall Phase 2b study results
Overall Phase 2b study results: Both doses of Roluperidone demonstrated statistically significant superiority to placebo in improving negative symptoms: Davidson et al., 2017; AJP Roluperidone was demonstrated to be superior on both PANSS-derived negative symptoms sub-scale as well on the BNSS, a sc
Slide 20: How many patients diagnosed with schizophrenia could benefit from roluperidone if approved?
How many patients diagnosed with schizophrenia could benefit from roluperidone if approved? 15%2,3 weighted-average 6-month relapse rate among patients with varying severity of negative symptoms 69% of patients have negative symptoms: ≈42%2,3 predominant/ prominent symptoms; ≈27%4 mild symptoms Prev
Slide 21: Decision Resources Group estimates roluperidone could account for 22% of schizophrenia market by 2027
Decision Resources Group estimates roluperidone could account for 22% of schizophrenia market by 2027 LAI – long-acting injectable. Other drug classes include oral, LAI, short-acting IM injections, and other formulations of typical antipsychotics; short-acting IM injections and other formulations of
Slide 22: Paradigm shift? Best strategy to help patients with negative symptoms?
Paradigm shift? Best strategy to help patients with negative symptoms? Earlier-better? Severity of Illness Chronic Progression of Negative Symptoms & Cognitive Impairment Youth 0-18 Adult 18-40 Mature >40 Cognitive Symptoms Negative Symptoms Positive Symptoms Intermittent acute episodes of positive
Slide 23: Additional Questions from Participants?
Additional Questions from Participants?
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