A Bermuda-registered company has received approval in the US to conduct a large, randomised study to track the effectiveness of a vaccine being developed to help smokers break their addiction to nicotine.

Celtic Pharma has been given clearance for a Investigational New Drug application (IND) for its vaccine TA-NIC.

The vaccine is said to work by causing nicotine that enters a patient’s bloodstream to encounter and then be bound by the TA-NIC vaccine, which creates an antibody too large to cross the blood-brain barrier and therefore reduces or eliminates any pleasure-giving stimulation from the nicotine.

The treatment is designed to curb the craving for nicotine and lead to smokers giving up the habit.

Previously the vaccine has been tested in 120 smokers in the UK, where it showed a level of effectiveness without any unexpected adverse events.

The new US study, under the IND, is designed to assess the efficacy and safety of TA-NIC in managing smoking cessation when given in conjunction with standard support treatments. It is a double-blind, multi-centre dose-ranging trial, enrolling up to 200 patients in each of three treatment arms. The primary endpoint of the study is the abstinence rate at six months.

Michael Earl, commercial director at Celtic Pharma Development Services, said: “There is an urgent need for a more effective treatment for nicotine addiction with nearly 5 million people dying each year from tobacco use, according to the World Health Organisation.

“With more than 1.2 billion people globally still smoking, the WHO predicts half of those will eventually be killed by tobacco. TA-NIC has the potential to be a key driver in the treatment of nicotine addiction. Given the potential of this product, we are already seeing considerable interest from pharmaceutical companies who may want to acquire this product when the results of this study are available.”

Stephen Evans-Freke and John Mayo, managing general partners of Celtic Pharma, which is based in Bermuda with offices in New York and London, said: “This is a significant milestone in the development of an effective treatment for all smokers wanting to quit. There are several nicotine addiction vaccines in development, but TA-NIC is the first to enter a robust randomised study to evaluate the effectiveness of TA-NIC as a treatment for nicotine addiction.”