ATI-1013 (Antidote Therapeutics), a fully human anti-nicotine monoclonal antibody, has been granted Orphan Drug Designation for the treatment of Buerger’s disease (thromboangitis obliterans). 

Buerger’s disease is a nonatherosclerotic, segmental inflammatory disorder that affects small and medium vessels of the upper and lower extremities and is strongly associated with tobacco exposure. ATI-1013 works by neutralizing nicotine in the blood. Animal studies have demonstrated that following an injection of nicotine, ATI-1013 blocked nicotine-induced increases in blood pressure, reduced nicotine levels in the brain by >90%, and reduced the vasoconstrictive peripheral effects of nicotine on blood vessels. 

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“Currently there are no approved treatments for Buerger’s disease, which is a distinct and very severe type of peripheral arterial disease,” says Matthew Kalnik, PhD, President and CEO, Antidote Therapeutics. “This is an important milestone and we’re very pleased to receive Orphan Drug Designation from the FDA.”

The Company is currently seeking partnership and funding for further clinical development. Research thus far has been partially funded by a grant from the National Institute of Health, National Institute on Drug Abuse. 

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