Phase 2 Study Update of TC-6987 for Asthma
Targacept, Inc. announced revised top-line results from its Phase 2 trial of TC-6987 in asthma.
Following identification of an error in the application of the agreed statistical analysis plan, a reanalysis revealed a 2mL decrease in the change in forced expiratory volume (FEV1) from baseline to pre-dosing on day 28, which resulted in TC-6987 no longer achieving the study's protocol-defined success criteria on that co-primary endpoint. However, TC-6987 continued in the reanalysis to meet protocol-defined success criteria on the study's other co-primary endpoint, change in FEV1 from baseline to two hours post-dosing on day 28. Reanalysis of the post-dose measure revealed an incrementally stronger signal of a drug effect than the initial analysis.
TC-6987 is a modulator of the alpha7 neuronal nicotinic receptor.
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