Transforming the Possible in Neuroscience
Topline Data for Phase 1b Trial of CVL-231 in Schizophrenia
June 2021
Forward-Looking Statements
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Forward-looking statements in this presentation include, but are not limited to: statements about the potential attributes and benefits of our product candidates, including with respect to receptor subtype selectivity, activity, side effect and tolerability profile and relevant indications; the format and timing of our product development activities and clinical trials, including the design of clinical trials and the timing of initiation, completion and data readouts for clinical trials; statements about the advancement of CVL-231 into a Phase 2 program in schizophrenia and plans to explore additional related; the timing and outcome of IND submissions and other regulatory interactions; the ability to compete with other companies currently marketing or engaged in the development of treatments for relevant indications; the size and growth potential of the markets for product candidates and ability to serve those markets; the rate and degree of market acceptance of product candidates, if approved; the potential effects of the business combination; the amount and timing of payments we may receive pursuant to the tavapadon financing transaction; the sufficiency of our financial resources, including to fund the tavapadon Phase 3 development program through NDA submission and to allocate capital to earlier stage assets; and our cash runway.
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In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame, or at all. The forward-looking statements in this presentation represent our views as of the date of this presentation. We anticipate that subsequent events and developments will cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we have no current intention of doing so except to the extent required by applicable law. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this presentation.
© Cerevel Therapeutics Holdings, Inc. | 2 |
Agenda
Introduction
Overview
Matthew Calistri
Vice President, Investor Relations
Tony Coles, M.D.
Chairperson & Chief Executive Officer
CVL-231 Background and MOA
John Renger, Ph.D.
Chief Scientific Officer
Trial Design & Results
Raymond Sanchez, M.D.
Chief Medical Officer
Q&A | All |
© Cerevel Therapeutics Holdings, Inc. | 3 |
Summary of Topline Results
• Both doses of CVL-231 demonstrated clinically meaningful improvements in
PANSS Total Score:
o 30 mg QD: -19.5 pts at week 6
- 20 mg BID: -17.9 pts at week 6
- Statistically significant difference in PANSS Total Score versus placebo*:
- 30 mg QD: -12.7 pts (p=0.023) at week 6
- 20 mg BID: -11.1 pts (p=0.047) at week 6
- Clinically meaningful improvements in both PANSS Positive and PANSS Negative subscales
- Generally well-tolerated:
- Discontinuation rates similar between treatment and placebo (22% for each arm including placebo)
- Not associated with extrapyramidal side effects or weight gain
- Gastrointestinal (GI) side effects were infrequent and were similar between treatment and placebo
- Serious adverse events included COVID-19, accidental overdose, and exacerbation of schizophrenia (one instance of each)
- Data support advancing CVL-231 into Phase 2 program in schizophrenia and evaluating the potential for this mechanism in additional indications, including dementia-related psychosis
*Trial originally designed to be 59% powered to detect 7 point difference in PANSS total score vs. placebo
© Cerevel Therapeutics Holdings, Inc. | 4 |
Cerevel's M4 PAM is a Potential Next Generation Antipsychotic
M4 PAM (CVL-231) | Opportunity for Innovation in Schizophrenia |
Potential New Standard of Care | Current Standard of Care Uses Same |
Mechanism of Action (MOA) as Therapies from the 1950s |
Potential First-in-Class | Large | ~20M | >$9B | ~3.5% | |||||||||||
Market | Patients | Revenues in | Growth | ||||||||||||
Therapy | |||||||||||||||
Worldwide | 2018 | per year | |||||||||||||
with Novel MOA | |||||||||||||||
M4 Selective | |||||||||||||||
Limited | High | ||||||||||||||
Targeted Muscarinic Activity | Significant | Lead to | Compliance | Relapse Rates | |||||||||||
Side Effect and | 60% | 77% | 90% | ||||||||||||
Need for New | |||||||||||||||
Improved Tolerability | at 1 year | at 2 years | |||||||||||||
Treatment | Tolerability Issues | Progression and | |||||||||||||
Option | |||||||||||||||
Lead to | worsening of disease | Lead to | |||||||||||||
High Discontinuation | |||||||||||||||
74% | |||||||||||||||
Within 18 months |
Debilitating side effects of atypicals often lead to discontinuation and relapse, driving a vicious cycle of disease progression
Source: World Health Organization, DRG Market Research, Global Data | © Cerevel Therapeutics Holdings, Inc. | 5 |
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Cerevel Therapeutics Holdings Inc. published this content on 29 June 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 29 June 2021 10:43:02 UTC.