Bermuda-based Celtic Pharmaceuticals Holdings, a private equity investment firm focused on the biotechnology and drug industries, says that enrollment has been completed in a US Phase IIb trial of its nicotine vaccine, TA-NIC.
The firm explained that the study, which is a dose-ranging, placebo-controlled assessment, is designed to examine the drug's effect on smoking abstinence rate after six months. The program is powered to provide 90% confidence of detecting a doubling of the abstinence rate achieved in the control group. To date, more than half of the participants have received the full seven-dose treatment course, and the drop out rate is less than 10%.
Celtic Pharma said that initial data is expected in the second quarter of next year, at which point it intends to sell the product as a Phase III-ready candidate.
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