Targacept (TRGT) Reports Split Results from Two Phase 2s of TC-6987
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Targacept, Inc. (Nasdaq: TRGT), has announced top-line results from two separate exploratory Phase 2 studies of its product candidate TC-6987 conducted in the United States, one in asthma and one in type 2 diabetes.
In the asthma study, oral TC-6987 met protocol-defined success criteria (one-sided p < 0.1) on both co-primary outcome measures, change from baseline in forced expiratory volume for adjunct TC-6987 compared to adjunct placebo measured at two time points on day 28 (51ml and 58ml). In the type 2 diabetes study, the primary outcome measure, change in fasting plasma glucose, was not met, and Targacept will not pursue further development of TC-6987 as a treatment for diabetes. TC-6987 is a modulator of the alpha7 neuronal nicotinic receptor (NNR) discovered by Targacept scientists using Pentad™, the company’s proprietary drug discovery platform.
TC-6987 was generally well tolerated in both studies reported today. There were no clinically meaningful changes in cardiovascular parameters in either study, an important finding that differentiates TC-6987 from many other alpha7 modulators. There were no treatment-emergent adverse events that led to discontinuation in the TC-6987 dose group in the asthma study and no clinically significant difference in the number of treatment-emergent adverse events that led to discontinuation between the TC-6987 and placebo dose groups in the type 2 diabetes study. Adverse events reported in at least five percent of patients in the TC-6987 dose group and at least twice as often as in the placebo dose group occurred only in the type 2 diabetes study and were hyperglycemia (5%) and dizziness (5%). There was one serious adverse event in each dose group in the asthma study, and one serious adverse event in the TC-6987 dose group in the type 2 diabetes study. All were deemed by the investigator to be not related to study drug.
There were multiple secondary outcome measures in the asthma study, with no consistent trends between TC-6987 and placebo observed. Analyses of the full datasets from both studies are ongoing.
In the asthma study, oral TC-6987 met protocol-defined success criteria (one-sided p < 0.1) on both co-primary outcome measures, change from baseline in forced expiratory volume for adjunct TC-6987 compared to adjunct placebo measured at two time points on day 28 (51ml and 58ml). In the type 2 diabetes study, the primary outcome measure, change in fasting plasma glucose, was not met, and Targacept will not pursue further development of TC-6987 as a treatment for diabetes. TC-6987 is a modulator of the alpha7 neuronal nicotinic receptor (NNR) discovered by Targacept scientists using Pentad™, the company’s proprietary drug discovery platform.
TC-6987 was generally well tolerated in both studies reported today. There were no clinically meaningful changes in cardiovascular parameters in either study, an important finding that differentiates TC-6987 from many other alpha7 modulators. There were no treatment-emergent adverse events that led to discontinuation in the TC-6987 dose group in the asthma study and no clinically significant difference in the number of treatment-emergent adverse events that led to discontinuation between the TC-6987 and placebo dose groups in the type 2 diabetes study. Adverse events reported in at least five percent of patients in the TC-6987 dose group and at least twice as often as in the placebo dose group occurred only in the type 2 diabetes study and were hyperglycemia (5%) and dizziness (5%). There was one serious adverse event in each dose group in the asthma study, and one serious adverse event in the TC-6987 dose group in the type 2 diabetes study. All were deemed by the investigator to be not related to study drug.
There were multiple secondary outcome measures in the asthma study, with no consistent trends between TC-6987 and placebo observed. Analyses of the full datasets from both studies are ongoing.
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