SAN CARLOS, Calif., Jan. 3, 2013 /PRNewswire/ -- Savant HWP, Inc. today announced the receipt of a three-year grant to support the development of 18-MC (18-methoxycoronaridine) as a potential orally active treatment for drug addiction, obesity and other forms of compulsive behavior. The grant, Award Number U01DA034986 given by the National Institute on Drug Abuse (NIDA) of the National Institutes of Health (NIH), provides a total of $6,486,657 to support IND-enabling studies and GMP Scale-Up of 18-MC for use in clinical trials. Savant expects to begin human clinical safety studies of 18-MC in Brazil in early 2013, where the drug will also be studied as a potential treatment for leishmaniasis, and to begin U.S. clinical development in addiction in 2014.
"Unlike current treatments for drug addiction and nicotine abuse, 18-MC uniquely targets the central dopamine "reward" pathway involved in all forms of addictive "pleasure-seeking" behaviors, including over-eating," said Stephen L. Hurst, Savant HWP Chairman and Chief Executive Officer. "Years of preclinical research using a variety of addiction models, by Savant's scientific founder, Stanley D. Glick, PhD, MD, Director of the Center for Neuropharmacology and Neuroscience at Albany Medical College, suggests this compound has the potential to bring a major treatment advance to the fields of addiction medicine and obesity therapy."
"18-MC is likely to be the first of a new generation of agents effective against a broad spectrum of addictions—from hard drugs such as heroin and cocaine, to alcohol, nicotine and even sugary, high-fat foods, possibly reducing obesity rates," said Dr. Glick, who has studied the neurobiology of addiction for 40 years. "We're also hopeful that this drug will provide the additional benefit of relief for a completely unrelated disorder, leishmaniasis, which creates painful skin lesions as well as damaging internal organs."
18-MC is an alpha-3-beta-4 nicotinic receptor antagonist that modulates excessive dopamine fluctuations in the mesolimbic system of the brain. This mechanism of action differs from all current medications used to treat addiction that are either agonists or antagonists for the addiction substance's primary receptor site.
Data from animal models have shown 18-MC efficacy in a broad array of substance addictions. 18-MC has been studied in models of a broad array of substance addictions, including cocaine, opiate, methamphetamine, nicotine and alcohol. It has also shown activity in animal models of obesity. 18-MC has been uniquely shown to block cue-induced reinstatement of addictive behaviors, suggesting it may help to not only halt addiction but also help prevent drug relapses longer term.
18-MC and similar proprietary compounds, to which Savant holds exclusive rights, are orally active, synthetic organic molecules designed around a common coronaridine chemical backbone. Such a molecular backbone is also common to a number of plant-based medicinal compounds including ibogaine, a substance that has been used outside the United States to treat addiction with anecdotal reports that a single dose can end heroin withdrawal and craving in humans, but which has cardiovascular and other toxicities including hallucinations. 18-MC was the result of rational drug design program aimed at generating a molecule with anti-addictive properties that lacked the toxicities seen with ibogaine.
The Substance Abuse and Mental Health Services Administration estimates that over 22.6 million Americans (2010 data) had a chemical substance dependence or abuse problem, whose health and social cost to society exceeds $500 billion annually. While approved treatments exist for certain drugs, there are no treatments for craving for either cocaine or meth-amphetamine addiction, and no approved drug significantly affects drug craving longer term for any form of addiction. Thus an effective drug that helps to end the cycle of withdrawal and relapse by targeting craving could potentially capture a significant portion of a multi-billion dollar market.
About Savant HWP, Inc.
Savant HWP, Inc., based in San Carlos, CA, is a privately held, health, wellness and prevention company currently focused on unmet medical needs in addiction medicine and selected other global health issues. The company's lead program is focused on the development of 18-MC, a novel compound that targets the dopamine "reward" pathway in the brain that drives pleasure-seeking behaviors associated with addiction, obesity and many forms of compulsive behavior. Savant expects to begin Phase 1 clinical trials of 18-MC in Brazil in early 2013 and to file a U.S. Investigational New Drug application to begin U.S. trials of 18-MC in 2014. For more information, please visit our web site at http://www.savanthwp.com.