Enter the text here that is the new abstract information for your application. This section must be no longer than 30 lines of text.

Cigarette smoking is the leading cause of death and morbidity from any addictive drug, responsible for 400,000 deaths per year in the US, and direct healthcare costs exceeding $170 billion/yr. Only ~20% of smokers achieve long-term abstinence using standard of care pharmacotherapies and there have been no FDA authorized anti-smoking treatments with a novel mechanism of action (MOA) since 2006. Following a recent pre- IND meeting with the FDA for ATI-1013 (an anti-nicotine human monoclonal antibody with a novel MOA that has achieved pre-clinical proof-of-concept), this project is focused on completing the remaining preclinical drug development and regulatory work in accordance with the specific FDA recommendations received to obtain an approved IND and begin clinical testing.