TC-5619 is a novel small molecule that is highly selective for the alpha7 neuronal nicotinic receptor, which Targacept refers to as NNR. It was discovered by Targacept scientists using Targacept’s proprietary drug discovery platform known as Pentad. Targacept expects this Phase 2 trial of TC-5619 to complete in the first half of 2011.
The multi-center Phase 2 clinical proof of concept ADHD trial is a double-blind, placebo controlled, randomised, parallel group study being conducted in the US. The trial is planned to enroll up to 125 patients ages 18 to 65.
As with Targacept’s ongoing Phase 2 clinical proof of concept trial of TC-5619 in cognitive dysfunction in schizophrenia (CDS), the trial design provides for patients to be randomly assigned to one of two cohorts, TC-5619 or placebo, and dosed over a 12-week period.
Patients randomised to the TC-5619 arm is expected to be up-titrated every four weeks and tested on each of three doses of TC-5619. The primary efficacy outcome measure of the trial is change from baseline on the Conners Adult ADHD Rating Scale, a multimodal questionnaire assessment of symptoms and behaviors associated with ADHD in adults aged 18 and older.
Targacept said that ADHD trial is part of a recently expanded development program for TC-5619 that also includes its ongoing Phase 2 clinical proof of concept trial in CDS and other studies planned to be conducted by each of Targacept and its strategic collaborator AstraZeneca to support the potential advancement of TC-5619 into Phase 2 clinical development for Alzheimer’s disease.
AstraZeneca has the future right to license TC-5619 for various cognitive disorders under the parties’ December 2005 collaboration agreement.