Targacept has initiated two separate Phase II studies of its TC-6987 product candidate, one in patients with asthma and one in patients with type II diabetes.
It is hoped that the trials will help to guide the selection of the therapeutic indications for which TC-6987 is best suited for later-stage development.
The Phase II study in asthma is a multicentre, double-blind, placebo-controlled, randomised and parallel-group trial, which is being conducted in the US.
The study will enrol approximately 90 adults with mild-to-moderate asthma, who will be randomised to receive either TC-6987 or a placebo.
The primary efficacy outcome measure of the study is change in forced expiratory volume from baseline to end of dosing in patients receiving TC-6987 compared to the placebo.
The study will also assess safety, tolerability and pharmacokinetics of TC-6987.
The Phase II study in Type II diabetes is a multicentre double-blind, placebo-controlled, randomised, parallel-group trial being conducted in the US.
The study will enrol approximately 120 adult patients with type II diabetes, who will be randomised to receive either TC-6987 or a placebo.
The primary efficacy outcome measure of the study is change in fasting plasma glucose from baseline to end of dosing in patients receiving TC-6987 compared to the placebo.
The study will also evaluate safety, tolerability and pharmacokinetics of TC-6987.
TC-6987 is a modulator of the alpha7 neuronal nicotinic receptor. It has demonstrated a potent anti-inflammatory response in a variety of preclinical studies.
