U01DA058547

Ind-Enabling Studies in Support of First in Human Safety Studies of a Novel Anti-Nicotine Human Monoclonal Antibody

Tobacco use is the leading preventable cause of illness and death in the world today. Over 30 million Americans smoke tobacco. Nicotine is responsible for smokers becoming addicted to tobacco and keeps them addicted long-term. Currently available FDA-approved smoking cessation treatments have modest efficacy, and no novel pharmacotherapies have been approved since 2006. Development of new and more effective medications is needed to reduce tobacco smoking, which, despite dramatic progress, remains the single leading cause of addiction-related death and illness in the U.S.

The focus of this project is advancing the development of a first-in-class, nicotine-specific, human monoclonal antibody, ATI-1013, that has achieved pre-clinical proof-of-concept as a treatment for nicotine addiction. ATI-1013's development plan is aimed at smokers with an immediate medically recognized need to quit smoking to slow the progression of their disease: the over 5 million smokers in the U.S. who have smoking-attributable diseases (e.g., cardiovascular disease, lung and other cancers, respiratory disease). ATI-1013's mechanism of action reduces nicotine exposure without acting on nicotinic receptors, offering a novel strategy compared to existing smoking cessation medications.

The overarching objective of this proposal is to progress the development of ATI-1013 from its current "mid" pre-clinical development stage to an approved IND for subsequent conduct of a First in Human (FIH) Phase 1 clinical trial. The specific aims are focused on completing IND-enabling safety studies, manufacturing of clinical drug supply, and preparation/filing and approval of the IND with the FDA for the FIH clinical trial of ATI-1013 in healthy normal non-smokers and smokers. Thus, the key goals are to complete all the requisite preclinical safety studies, assay development, CMC processes, production of high-quality drug product, and clinical trial requirements needed to initiate the Phase 1 study upon IND approval.

Antidote Therapeutics

TO SUPPORT BASIC, CLINICAL, TRANSLATIONAL, AND IMPLEMENTATION RESEARCH IN THE FIELD OF SUBSTANCE USE. TO DEVELOP NEW KNOWLEDGE AND APPROACHES FOR THE PREVENTION, DIAGNOSIS, AND TREATMENT OF DRUG USE, MISUSE, AND ADDICTION, DRUG OVERDOSE, AND RELATED HEALTH OUTCOME, INCLUDING HIV/AIDS. TO SUPPORT RESEARCH TRAINING AND RESEARCH SCIENTIST DEVELOPMENT. TO SUPPORT DISSEMINATION OF RESEARCH FINDINGS. SMALL BUSINESS INNOVATION RESEARCH (SBIR) LEGISLATION IS INTENDED TO EXPAND AND IMPROVE THE SBIR PROGRAMS TO EMPHASIZE AND INCREASE PRIVATE SECTOR COMMERCIALIZATION OF TECHNOLOGY DEVELOPED THROUGH FEDERAL SBIR RESEARCH AND DEVELOPMENT; INCREASE SMALL BUSINESS PARTICIPATION IN FEDERAL RESEARCH AND DEVELOPMENT; AND FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN THE SBIR PROGRAM. THE SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) LEGISTLATION IS INTENDED TO STIMULATE AND FOSTER SCIENTIFIC AND TECHNOLOGICAL INNOVATION THROUGH COOPERATIVE RESEARCH AND DEVELOPMENT CARRIED OUT BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS; FOSTER TECHNOLOGY TRANSFER BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS; INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT; AND FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN TECHNOLOGICAL INNOVATION.

93.279 - Drug Abuse and Addiction Research Programs

National Institute on Drug Abuse (NIDA) [HHS - NIH]

Sykesville, Maryland 217848213 United States

Single Zip Code

Grand Opportunity in Medications Development for Substance-Use Disorders (U01 Clinical Trial Optional) (PAR-19-327)

Amendment Since initial award the End Date has been extended from 04/30/26 to 04/30/27 and the total obligations have increased 226% from $4,026,705 to $13,125,765.