Targacept announces negative top-line results from exploratory study of TC-6499 in diabetic gastroparesis

Targacept, a company focused on developing NNR Therapeutics™ to treat patients suffering from serious nervous system and gastrointestinal/genitourinary diseases and disorders, has announced top-line results from a Phase 1/2 exploratory study of TC-6499 as a treatment for diabetic gastroparesis, a chronic disorder that slows or stops the passage of food from the stomach to the small intestine.

The Phase 1/2 exploratory study was a double-blind, placebo-controlled, randomised, four-way crossover study conducted at seven sites in the United States. A total of 21 subjects with diabetic gastroparesis completed the study and received one of four treatments (2mg, 5mg and 10mg of TC-6499 and placebo) in a randomised, crossover manner on each of four treatment visits, with each dosing period separated by approximately seven days. The primary endpoint of the study was change in gastric emptying half-time (BT_t1/2), as measured by a carbon (13C) labelled gastric emptying breath test, for each active treatment relative to placebo. The study also assessed the safety, tolerability and pharmacokinetics of TC-6499.

Results do not support further development of TC-6499 in diabetic gastroparesis

In the trial, TC-6499 did not meet the primary endpoint of the study, change in gastric emptying half-time (BT_t1/2), as measured by a carbon (13C) labelled gastric emptying breath test, relative to placebo.

“The results we saw do not support the prior signal we had seen suggesting that TC-6499 might increase gastric motility in this patient population,” said Dr. Stephen A. Hill, Targacept’s President and Chief Executive Officer. “While TC-6499 did demonstrate a positive safety and tolerability profile in this study, these results do not warrant further development of TC-6499 in this therapeutic area.”

For more information about Targacept, please visit www.targacept.com.