Research and Markets (http://www.researchandmarkets.com/research/g8jxmm/targacepts) has announced the addition of the "Targacept's TC-5619 - The prospects for this fully-owned alpha-7 neuronal nicotinic receptor agonist" report to their offering.
In 2011, Targacept reported that its phase II proof of concept study of TC-5619 in cognitive dysfunction in schizophrenia (CDS) met the pre-specified primary endpoint, while the trial in ADHD missed the primary endpoint but showed signals of drug activity. However, AstraZeneca subsequently decided not to exercise its option to license TC-5619, and Targacept retains full rights to the compound. The company plans to continue its development with a new phase IIb trial but with a slight change in direction.
In this report, we review the scientific rationale, the early safety and activity data as a means to gauge TC-5619's prospects in what is a huge market opportunity with a significant unmet need.
Key Topics Covered:
INTRODUCTION AND BACKGROUND
- Clinical picture
- Disease mechanisms
- Current treatments focus on neurotransmitters
- Potential mechanisms and treatments under investigation
- Non-pharmacologic approaches to treatment
TC-5619 - an alpha-7 NNR agonist
1. Mechanism of action and rationale
2. Favorable evidence in animal models
3. Adequate preclinical safety
4. Phase I
5. Phase II proof-of-concept study in cognitive dysfunction in schizophrenia
6.TC-5619 in other indications
- Phase II in attention deficit/hyperactivity disorder
- Phase I in Alzheimer's Disease
1. The MATRICS initiative:
- Inclusion criteria:
- Add-on Design:
- Outcome measures:
- Cognitive outcome:
- Functional outcome:
- Outcomes measures - International issues
1. Concens about the choice of endpoints
2. Statistical concerns
3. Dosing concerns
4. Functional Outcomes - required in the setting of cognition
5. Secondary Endpoint - what do they show?
6. Differential Effect In Smokers Vs. Non-Smokers
7. Geographical Imbalances
8. Concomitant Medications
9. Safety And Adverse Events
10. Challenges For Phase III Trials
MARKET OPPORTUNITY AND COMPETITION
1. The market opportunity
- Neuronal nicotinic receptor agonists
- Drugs with other mechanisms of action
For more information visit http://www.researchandmarkets.com/research/g8jxmm/targaceptsBusiness Wire
Last updated on: 07/01/2013
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