The Phase II studies are designed to offer valuable insights 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 parallel group trial, which is being conducted in the US.
The study will enroll approximately 90 adult patients 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 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 enroll 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 placebo.
The study will also evaluate safety, tolerability and pharmacokinetics of TC-6987.
TC-6987 is a modulator of the alpha7 neuronal nicotinic receptor, and it had demonstrated a potent anti-inflammatory response in a variety of preclinical studies conducted by the company.