CAMBRIDGE, Mass.--(BUSINESS WIRE)--Ethismos Research Inc. a clinical-stage pharmaceutical company focused on addiction and depression founded by Anthony McKinney, today announced its acquisition of the intellectual property assets of Euthymics Bioscience Inc. This is comprised of twelve families of patents and patent applications including those underlying amitifadine, a serotonin-preferring triple reuptake inhibitor previously under phase 2 development by Euthymics. Amitifadine is believed to offer improved efficacy as a medication for smoking cessation (along with standard behavioral therapy). With more than a billion smokers worldwide, nicotine addiction is a serious problem since current smoking cessation treatments have modest efficacy with over 90% of those attempting to quit suffering relapse and returning to their old ways.
In the United States, only 7% of adult smokers who attempt to quit are successful.(1) There are approximately 40 million US adults who smoke cigarettes daily and over half attempt to quit each year. Of these over one third use medications to help them stop smoking. In Europe and China there are over 100 million and 200 million daily smokers, respectively. In all territories, the vast majority of smokers attempting to quit will relapse, most within days or weeks of the attempt and often due to mood/anxiety or giving in to impulsive urges when encountering a smoking cue.
“We want to help smokers break the bonds of tobacco,” said Anthony McKinney, Ethismos’ Founder and CEO. “At Ethismos we are working to develop amitifadine as a novel smoking cessation medication with potentially higher efficacy than standard medications because amitifadine has pharmacology to address the primary reasons that smokers relapse. We hope to demonstrate that a decrease in withdrawal effects, less impulsive smoking in response to behavioral cues, and preventing post-cessation weight gain lead to less relapse.”
Amitifadine is a well-characterized Triple Reuptake Inhibitor that addresses the factors that drive relapse. Modulation of serotonin addresses the mood component of withdrawal such as the depression that frequently develops post-quit. Dopamine reuptake inhibition addresses the craving for nicotine and may also help with the lack of pleasure developing during withdrawal (anhedonia). Modulation of norepinephrine is believed to decrease impulsivity to smoke when encountering cues and may help with post-quit anxiety. And norepinephrine and dopamine reuptake inhibition combine to combat the weight gain that frequently accompanies smoking cessation.
Mr. McKinney has a strong background working with amitifadine since he was founding CEO of Euthymics starting in 2010. He also served as founding CEO of Neurovance that was spun out from Euthymics as a sister company to advance centanafadine, a norepinephrine-preferring triple for ADHD. In March 2017 Otsuka acquired Neurovance for $250m in near-term and development milestones.
Mr. McKinney added, “At Ethismos, we are reassembling many of the personnel that completed and analyzed the centanafadine phase 2b trial and assembled the End of Phase 2 package for the FDA.”
The Ethismos phase 2 smoking cessation clinical trial program will be led by Jed Rose, PhD, Director of the Rose Research Center and a leader in the smoking cessation field who is co-inventor of the nicotine skin patch as well as e-cigarette technologies. Dr. Rose states, "Current smoking cessation treatments have only modest long-term success rates, so new pharmacotherapies that address the multiple components of addiction are urgently needed."
Beyond smoking cessation, there are additional opportunities to develop amitifadine to address alcohol use disorder and other substance use disorders. Ethismos will also consider amitifadine for use in treatment resistant depression. Clinical trials have previously demonstrated that amitifadine is well tolerated with favorable outcomes on weight and sexual function.
The word “ethismos” is a concept from ancient Greece that relates to the customs we are taught and the habits we develop as we go through life. More information is available at www.ethismos.com.
(1)Babb S, Malarcher A, Schauer G, Asman K, Jamal A. Quitting Smoking Among Adults — United States, 2000–2015. MMWR Morb Mortal Wkly Rep 2017;65:1457–1464.
