Research and Markets: Cypress Bioscience's and BioLineRx's CYP1020 - Will it improve cognitive function?
Research and Markets (http://www.researchandmarkets.com/research/3xpzqn/cypress) has announced the addition of the "Cypress Bioscience's and BioLineRx's CYP1020 - Will it improve cognitive function?" report to their offering.
Cypress Bioscience recently acquired CYP-1020 from BioLineRx. It is in phase II development for use in schizophrenia. When metabolized, CYP-1010 becomes perphenazine (an approved 'typical' antipsychotic) and GABA (a neurotransmitter active at its corresponding receptor). The sponsors hope that the GABA 'tail' on the molecule will improve cognition and also lessen side effects. Current therapies do not address cognition deficits, which are the most predictive of poor social functioning. In this report, we review the early data for CYP-1020 relative to antipsychotic and cognition effects. We also discuss the path to market in order to secure an improved cognition claim, the antipsychotic market, and the potential commercial implications should CYP-1020 live up to its early promise.
Key Topics Covered:
INTRODUCTION AND BACKGROUND
- Clinical picture
- Disease mechanisms
- Current treatments focus on neurotransmitters
1. Rationale for use and preclinical data
2. Phase I
3. Phase II
- Effective Anti-psychosis via GABA Level Enhancement (EAGLE)
4. Future plans
CLINICAL AND REGULATORY DISCUSSION
1. Observations related to the early clinical data
2. The regulatory environment
- General issues of clinical trial design and overall NDA content
- Guidance relative to cognitive function claims
- Precedents illustrate FDA's approach to balancing risk and benefit
- In summary
3. What do we know about perphenazine and GABA that informs CYP-1020?
- Under Review
- Phase III
- Phase II
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