US-based clinical-stage biopharma company Targacept (Nasdaq: TRGT) plans to halt development of TC-5214 as a treatment for overactive bladder (OAB), after posting largely negative top-line results from a Phase IIb clinical trial of the compound. Adding to a string of failures, this latest news caused the firm’s shares to tumble nearly 30% in post-market trading yesterday.
In the trial, the high dose of TC-5214 demonstrated mixed results on the co-primary endpoints by providing a statistically-significant reduction in micturition frequency (p=0.033) and an improvement that did not reach statistical significance on episodes of urinary incontinence (p=0.379) per 24 hours, after 12 weeks of treatment. As a consequence of these results, Targacept is discontinuing further development of TC-5214 in OAB.
In this trial, TC-5214 was considered generally safe and well tolerated. However, there was a placebo corrected 15.1% rate of constipation and a 5.9% rate of urinary tract infection in the high dose group. Analyses of the full dataset from the trial are ongoing and Targacept plans to publish more detailed results.
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