GAITHERSBURG, Md.--(BUSINESS WIRE)--Sep 5, 2018--Antidote Therapeutics, Inc., a biopharmaceutical company developing novel nicotine-blocking therapies to treat diseases caused or worsened by nicotine, announced today that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for ATI-1013, a fully human, anti-nicotine monoclonal antibody for the treatment of Buerger’s Disease.

Buerger’s Disease (thromboangitis obliterans) is a rare disorder that is caused by cigarette smoking or ingesting nicotine from other sources (such as smokeless tobacco) in which small blood vessels in the arms and or legs become blocked. This condition reduces blood flow to the affected areas, causing pain, skin ulcers and eventual severe tissue damage that often leads to gangrene and the need for amputation. Buerger’s Disease largely affects young or middle-aged cigarette smokers.

“The mechanism by which smoking induces Buerger’s disease is not known, but nicotine plays the most important role in initiation and progression of this vascular disease,” says Jeffrey W. Olin, DO, FACC, FAHA, Professor of Medicine at Icahn School of Medicine at Mount Sinai Hospital. “While some patients are able to stop smoking or using tobacco in other forms, many are not, therefore a human monoclonal antibody that blocks the effects of nicotine may be a major advance in the treatment of patients with Buerger’s disease.”

ATI-1013 is a proprietary compound that neutralizes nicotine in the blood. Studies in animals have shown that following an injection of nicotine, ATI-1013 blocks nicotine-induced increases in blood pressure, reduces nicotine levels in the brain by more than 90%, and reduces the vasoconstrictive peripheral effects of nicotine on blood vessels. Research into ATI-1013 has been partially funded by a grant from the National Institute of Health, National Institute on Drug Abuse. 2

“Currently there are no approved treatments for Buerger’s Disease, which is a distinct and very severe type of peripheral arterial disease (PAD),” says Matthew Kalnik, Ph.D., President and Chief Executive Officer, Antidote Therapeutics, Inc. “This is an important milestone and we’re very pleased to receive Orphan Drug Designation from the FDA.”

The Orphan Drug Act grants orphan status to drugs and biologics which are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases and disorders that affect fewer than 200,000 people in the U.S. Under the Act, the FDA may provide grant funding toward clinical trial costs, tax advantages, FDA user-fee benefits, and seven years of market exclusivity in the United States following marketing approval by the FDA.

About Antidote Therapeutics, Inc.

Antidote Therapeutics, Inc. is a biotechnology company with a portfolio of first-in-class nicotine-blocking drugs to treat diseases caused or worsened by nicotine. In addition to Buerger’s Disease, ATI-1013 is also being investigated for Critical Limb Ischemia and nicotine addiction, and the company has other product candidates that neutralize or eliminate nicotine in the blood. Results of a preclinical, proof-of-concept study of its nicotine-degrading enzyme, NicA2, were published recently in the journal, BMC Biotechnology2, and validate the approach of using a nicotine-degrading enzyme to treat nicotine addiction and prevent relapse.

Unlike FDA-approved smoking cessation treatments, Antidote’s candidates do not contain nicotine or interact with nicotine-receptors in the brain or body. Instead, they are designed to trap or eliminate nicotine in the blood, having the dual benefit of preventing nicotine from reaching the brain and neutralizing nicotine’s direct, harmful effects and, which reduces the addictiveness of nicotine from cigarettes, e-cigarettes and smokeless tobacco. For further information, please visit www.antidotetx.com.

Antidote Therapeutics is advancing ATI-1013 for clinical development and is currently seeking partnerships and funding. Interested parties may contact the company for further information.

1 R01DA038877 Lead Optimization and Preclinical Development of Human Nicotine-Specific mAbs

2https://bmcbiotechnol.biomedcentral.com/articles/10.1186/s12896-018-0457-7

View source version on businesswire.com:https://www.businesswire.com/news/home/20180905005618/en/

CONTACT: For Antidote Therapeutics, Inc.

Investor Relations

ir@intodotetx.com

or

Partnerships

bd@antidotetx.com

or

Media

Peggy Ballman, 908-310-7721 (mobile)

margaretballman@comcast.net

KEYWORD: UNITED STATES NORTH AMERICA MARYLAND

INDUSTRY KEYWORD: HEALTH BIOTECHNOLOGY CLINICAL TRIALS PHILANTHROPY RESEARCH OTHER SCIENCE OTHER PHILANTHROPY FDA SCIENCE FOUNDATION FUND RAISING GENERAL HEALTH

SOURCE: Antidote Therapeutics, Inc.

Copyright Business Wire 2018.

PUB: 09/05/2018 10:30 AM/DISC: 09/05/2018 10:30 AM

http://www.businesswire.com/news/home/20180905005618/en