Targacept, a clinical-stage biopharmaceutical company, has reported the data from two separate exploratory Phase 2 studies of its product candidate TC-6987 conducted in asthma and type 2 diabetic patients.
TC-6987 is a modulator of the alpha7 neuronal nicotinic receptor (NNR) that demonstrated a potent anti-inflammatory response in a number of preclinical studies and was well tolerated in Phase 1 clinical trials.
The asthma study was a double blind placebo-controlled parallel group Phase 2 trial that randomised 93 adult patients with persistent mild to moderate asthma into one of two cohorts and received either placebo or oral TC-6987 once daily, together with the low-dose inhaled corticosteroid, for four weeks.
In the asthma study, oral TC-6987 met protocol-defined success criteria on both co-primary outcome measures, change from baseline in forced expiratory volume (FEV1) for adjunct TC-6987 compared to adjunct placebo.
The double blind placebo-controlled parallel group Phase 2 trial randomised 112 adult diabetic patients into one of two cohorts and received either TC-6987 or placebo once daily for four weeks.
In the type 2 diabetes study, TC-6987 has not met the primary outcome measure of change in fasting plasma glucose from baseline to the last day of the dosing period.
Professor of Medicine at the University of North Carolina, School of Medicine, Department of Medicine in Chapel Hill, James Donohue said the exploratory asthma trial of TC-6987 as an adjunct to a low-dose inhaled corticosteroid showed a drug effect that was seen at the first assessment point, 30 minutes after initial dosing, and was sustained throughout the duration of the study, suggesting that TC-6987 has promise and may also have benefit in a monotherapy setting.
Targacept president and chief executive officer Donald deBethizy said that with the positive outcome in TC-6987 asthma study, the company has accomplished its goal of detecting in patients a signal of the potential of NNR Therapeutics in the treatment of disorders outside of the CNS, while at the same time further establishing a favourable safety and tolerability profile for the alpha7-selective NNR Therapeutic.
Targacept develops NNR Therapeutics that selectively modulate the activity of specific neuronal nicotinic receptors, the proteins that regulate vital biological functions that are impaired in various disease states.