Targacept, Inc. (NASDAQ: TRGT), a clinical-stage biopharmaceutical company developing novel NNR Therapeutics™, today 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 (FEV 1) 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 FEV 1 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.
|Change in FEV 1 for Adjunct TC-6987 compared to Adjunct Placebofrom Baseline to:|
|Pre-Dose on Day 28||Two hours Post-Dose on Day 28|
|Delta||One-sided p-value||Delta||One-sided p-value|
|Original Analysis||51 ml||0.090||58 ml||0.070|
|Corrected Analysis||49 ml||0.142||79 ml||0.052|
“As I said previously, this exploratory study in asthma accomplished our goal of detecting in patients a signal of the potential of NNR Therapeutics in the treatment of disorders outside of the CNS. We are in the process of considering potential next steps for this compound and indication,” said J. Donald deBethizy, Ph.D., Targacept’s President and Chief Executive Officer. “We regret not having discovered the statistical analysis error initially.”
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