Press Release

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

1. Schizophrenia

- Epidemiology

- Clinical picture

- Diagnosis

- 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

- Activity

- Safety

6.TC-5619 in other indications

- Phase II in attention deficit/hyperactivity disorder

- Phase I in Alzheimer's Disease

REGULATORY BACKGROUND:

1. The MATRICS initiative:

- Inclusion criteria:

- Add-on Design:

- Duration:

- Outcome measures:

- Cognitive outcome:

- Functional outcome:

- Outcomes measures - International issues

OPINION

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

2. Pipeline

- Neuronal nicotinic receptor agonists

- Drugs with other mechanisms of action

CONCLUSIONS

For more information visit http://www.researchandmarkets.com/research/g8jxmm/targacepts

Last updated on: 07/01/2013 16:00:07