Targacept (TRGT) Reports ID Error in Revised Top-Line Results from TC-6987 Phase 2
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Targacept, Inc. (NASDAQ: TRGT), announced revised top-line results from its exploratory Phase 2 clinical study of TC-6987 in asthma.
Following identification of an error in the application of the agreed statistical analysis plan, a reanalysis of the data was undertaken. As shown in the table below, as compared to the initially reported values, the reanalysis revealed a 2 ml 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.
Following identification of an error in the application of the agreed statistical analysis plan, a reanalysis of the data was undertaken. As shown in the table below, as compared to the initially reported values, the reanalysis revealed a 2 ml 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.
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