18-MC Well Tolerated by Subjects in Development Partner’s Study

SAN CARLOS, CA, USA I September 23, 2014 I Savant HWP, Inc., a privately held drug development company, today confirmed the initiation of human safety testing of 18-MC, an experimental treatment for many forms of addiction. A single dose of 18-MC, administered as part of a double-blind, placebo-controlled human safety study conducted by Savant’s South American partner, was well tolerated by healthy volunteers receiving the experimental drug. Savant HWP plans to develop 18-MC as a treatment for many forms of addiction and compulsive behavior, with an initial focus on cocaine and opiate dependencies. The company’s South American partner is developing 18-MC for the treatment of leishmaniasis, a parasitic disease that is widespread in parts of the tropics, subtropics, and southern Europe.

“It is particularly rewarding to announce the initiation of human safety testing for 18-MC during National Alcohol and Drug Addiction Recovery Month,” said Scott Freeman, M.D., Savant HWP co-founder, chairman, and chief medical officer. “I am pleased with our partner’s progress with the trial and that 18‑MC has been well tolerated in the volunteers who received the drug to date. Safety and dose-ranging studies are continuing, and we expect to present detailed results at medical meetings and in scientific publications at the conclusion of the trial.”

“This initial human study is the culmination of many years of preclinical testing in the Albany Medical College laboratory of 18-MC’s co-inventor, Stanley D. Glick, M.D., Ph.D., Professor Emeritus, Center for Neuropharmacology and Neuroscience at Albany Medical College,” said Stephen L. Hurst, J.D., Savant HWP president and chief executive officer. “Dr. Glick’s work has shown the potential of 18-MC to treat addiction to a wide range of substances in animal models, including cocaine, methamphetamine, opiates, nicotine and in compulsive over-eating of fatty and sugary foods.”

About 18-MC

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, 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 relapse 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. 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 these plant-based medicinal compounds. To date, Savant has received approximately $6.8 million in grant funding from the National Institute on Drug Abuse in support of 18-MC’s pre-clinical development.

About Savant HWP

Savant HWP, Inc., is a privately held pharmaceutical development company focused on unmet medical needs in addiction medicine and selected other global health issues including Chagas disease. 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.

SOURCE: Savant HWP