Buergers Disease Treatment, ATI-1013, Receives Orphan Drug Designation


The FDA has granted an orphan drug designation to Antidote Therapeutics, Inc.’s ATI-1013 for the treatment of Buerger’s disease.

Antidote Therapeutics, Inc.’s fully human, anti-nicotine monoclonal antibody, ATI-1013, has been granted an orphan drug designation by the US Food and Drug Administration (FDA) for the treatment of Buerger’s disease.

“Buerger’s Disease is ideally suited to the nicotine-blocking mechanism of action of ATI-1013 because nicotine is the main driver of this debilitating, underserved disease,” said Matthew W. Kalnik, PhD, president, CEO, and director of Antidote Therapeutics Inc to Rare Disease Report®. “Our development approach is unique in targeting disease outcomes rather than long-term smoking abstinence per se. The Orphan Drug Designation further validates this approach and can help accelerate our time to market. We’re in a strong position for IND filing and clinical testing and are actively seeking investors so we can make this treatment available to patients as soon as possible.”

A proprietary compound that neutralizes nicotine in the blood, ATI-1013 has been shown to block nicotine-induced increases in blood pressure, reduce the vasoconstrictive peripheral effects of nicotine on blood vessels, and reduce nicotine levels in the brain by more than 90%.

“Currently there are no approved treatments for Buerger’s Disease, which is a distinct and very severe type of peripheral arterial disease (PAD),” added Matthew Kalnik, PhD, president and chief executive officer, Antidote Therapeutics, Inc in a recent statement. “This is an important milestone and we’re very pleased to receive Orphan Drug Designation from the FDA.”

A rare disorder, Buerger’s disease is characterized by blocked small blood vessels in the arms and legs, which are caused by cigarette smoking or ingested nicotine from other sources, like smokeless tobacco. Due to the reduced blood flow in the affected areas, pain, skin ulcers, and eventual severe tissue damage that can often cause gangrene and lead to the need for amputation.

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