Targacept/GSK’s Nicotinic Receptor Modulator Fails Phase II Pain Study
This article was originally published in The Pink Sheet Daily
Executive Summary
Experimental pain killer performed no better than placebo, failing a proof-of-concept study for post-operative pain.
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Targacept's lead neuronal nicotinic receptor modulator candidate, TC-2696, provided no better pain relief than placebo in a Phase II study of patients who had their wisdom teeth extracted, the firm reported Dec. 4. TC-2696, a modulator of alpha-4-beta-2 NNRs, failed to meet the primary endpoints of superior pain relief at four and six hours after dosing compared to placebo, Targacept said in a release. The results "suggest that TC-2696 is not a viable therapeutic candidate for acute post-operative pain." In the proof-of-concept trial, 181 patients received a single dose of one of three strengths of the experimental pain killer, ibuprofen or placebo following third molar extraction surgery. Researchers found no clinically meaningful differences in the incidence of adverse events between the TC-2696 groups and the placebo group and reported no unexpected or serious adverse events. Winston-Salem, N.C.-based Targacept and GlaxoSmithKline announced in July that they would collaborate to develop TC-2696 and other NNR candidates in five therapeutic areas (1 (Also see "Targacept NNR Drug Development Is Smokin’ After GSK Cash Infusion" - Pink Sheet, 27 Jul, 2007.)). Targacept continues to analyze the data and will consider next steps regarding TC-2696 development along with GSK, the firm said. A second candidate under the collaboration, TC-6499, also an alpha-4-beta-2 NNR modulator, is in development for neuropathic pain. Targacept noted in its Nov. 8 third quarter 2007 earnings report that it had received authorization from French regulators to initiate clinical development of the candidate and expected to begin dosing "in the next few weeks." Targacept also has an NNR collaboration with AstraZeneca. Under an agreement inked in 2005, the firms are developing Targacept's NNR compounds to treat Alzheimer's disease, cognitive deficits in schizophrenia and other cognitive disorders (2 (Also see "AstraZeneca Licenses Nicotinic Alzheimer’s Treatment From Targacept" - Pink Sheet, 28 Dec, 2005.)). In August, AstraZeneca initiated a Phase IIb trial of TC-1734 (AZD3480), a modulator of alpha-4-beta-2 NNRs, for cognitive deficits in schizophrenia. The study is expected to finish by the end of 2008. That study is a double-blind, placebo-controlled trial randomizing 400 patients in the U.S. and Canada currently taking atypical antipsychotics. Patients will receive one of three doses of the experimental NNR or placebo for 12 weeks. The primary outcome measure is scores on the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) battery of cognitive tests. AstraZeneca also is conducting a Phase IIb study of the compound in patients with mild to moderate Alzheimer's that is expected to finish by the end of 2008. Targacept announced in November that AstraZeneca has an option on TC-5619, the lead compound in its alpha-7 NNR program. The candidate entered Phase I clinical development for cognitive disorders in July. - Shirley Haley ([email protected]) [Editor's Note: Look for an interview with Targacept CEO Donald deBethizy in an upcoming issue of "The Pink Sheet" DAILY.] |