WE WANT TO

HELP SMOKERS

BREAK THE BONDS OF

TOBACCO

 

 

ETHISMOS is a concept from ancient Greece and relates to the customs we are taught and the habits we develop as we go through life.  Our team develops medications to help achieve a change in habits, to support those returning to a life free of smoking.

 

ETHISMOS

WHO

We are developing a novel smoking cessation medication with potentially higher efficacy than standard medications. We hope to show less craving, fewer withdrawal effects, less impulsive smoking in response to behavioral cues, and less weight gain resulting in the possibility of less relapse

 

 

OUR TEAM

We have years of development experience with the triple reuptake inhibitor amitifadine and recent success with a related triple centanafadine, a research-stage NE-preferring triple for ADHD.*  We are reassembling the same team that completed and analyzed the centanafadine phase 2b trial and prepared the End of Phase 2 package for the FDA**

 

 

ANTHONY MCKINNEY

Founder & CEO

 

Anthony has held senior positions in several

emerging and established biotechnology companies

including Novazyme and Genzyme. He was a

founding executive with Orexigen, and founding

CEO with Ethismos’ predecessor companies,

Euthymics and Neurovance

 

 

 

 

 

 

John McKinney, MA, Clinical Operations Manager (full-time)

 

Katherine Laessig, MD, consulting CMO, Senior VP, Reg Affairs & Med Safety, RRD Int’l Former Deputy Director, Food & Drug Administration

 

Maryann Krane, Development/Regulatory consultant, RRD Int’l, former Genetics Institute, Ariad

 

Jennifer DiGiacinto, PharmD, Clinical Pharmacology consultant, RRD Int’l, Former clinical pharmacology, Food & Drug Administration

 

Jürgen Venitz, MD, PhD, Professor, Virginia Commonwealth, ADME/PK consultant

 

Professor David Heal, Clinical Pharmacology consultant, RenaSci

 

Edward M. Sellers, MD, PhD, Abuse liability consultant, DL Global Partners Inc.

 

Robert van Lier, PhD, consulting toxicologist - President at Strategic Toxicology Consulting, LLC, former Senior Research Advisor Eli Lilly

 

 

 

 

* Amitifadine acquired from Euthymics. In 2011 Neurovance was spun out from Euthymics as a sister company to advance centanafadine, a research-stage NE-preferring triple for ADHD. In March, 2017 Otsuka acquired Neurovance for $250m in up-front and near-term development milestones

**Consultants will come on board once fund-raising has been completed

 

> 1 billion smokers worldwide: 300m in China, 170M IN EUROPE, 100M IN INDIA: 60M IN US, 25M IN JAPAN, 23M IN BRAZIL ...

Tobacco Use Disorder: Relapse is the Major Risk

 

In many territories, a substantial number of smokers (up to half or more of smokers) attempt to quit each year, however, only 7% succeed (i.e, the vast majority will relapse)

 

HIGHER DEPENDENCE MAKES IT HARDER TO QUIT

 

According to the ITC Project China, 29% of smokers in China light up within 5 minutes of waking indicating a level of nicotine dependence higher than in any other territory. Patients attempting to quit with higher levels of dependence may find it more difficult and be more prone to relapse

 

 

 

EXISTING MARKET

 

Millions of smokers across the globe have made the decision to use medications to help them quit

 

Current medications address the craving. At ETHISMOS we are developing a treatment that addresses the cravings, and also addresses the depression, impulsivity to smoke, and weight gain that may accompany withdrawal and lead to relapse.

 

 

 

US

 

Approximately 40 million US adults smoke cigarettes daily; 55% of American smokers attempt to quit annually; 30% of those attempting to quit use medications to help them stop smoking

 

 

 

CHINA

 

Approximately 230 million Chinese adults smoke cigarettes daily; 22% of Chinese smokers attempt to quit annually; 11% of those attempting to quit use medications

 

 

 

 

EUROPE

 

Approximately 127 million European adults smoke cigarettes daily; 32% of Europeans attempt to quit annually; 28% of European smokers making quit attempts use medications to quit

 

 

 

 

 

WHY

 

HOW

Relapse is often due to new onset depression, craving, impulsivity to smoke, and weight gain in the months following smoking cessation

 

These withdrawal effects often occur following discontinuation of a drug of abuse. Withdrawal symptoms are often observed in many forms of addiction

 

 

 

 

 

 

 

 

 

Serotonin addresses the mood component of withdrawal such as new onset depression

 

Dopamine addresses the craving for nicotine

 

Dopamine may also help with the anhedonia or lack of pleasure during withdrawal

 

Norepinephrine addresses the impulsivity to resume smoking, e.g., when encountering a behavioral cue such as seeing someone else smoking

 

Norepinephrine and Dopamine combine to combat the weight gain that frequently accompanies smoking cessation

 

 

 

Amitifadine is a well-characterized Triple Reuptake Inhibitor that addresses why many people relapse

 

PREVIOUS HUMAN EXPERIENCE

 

 

  • Ten trials have evaluated amitifadine in 654 patients/subjects
  • Phase 1 and Phase 2 studies utilized doses ranging from 25 to 600 mg/day
  • Pilot Phase 2 study showed efficacy and safety in Major Depressive Disorder at 100 mg per day 6 weeks
  • A major Phase 2/3 study showed good tolerability in MDD at 100 mg per day for up to 12 weeks

 

 

 

 

 

ETHISMOS SMOKING CESSATION PROGRAM

 

 

  • Led by Dr. Jed Rose, Director of the Rose Research  Center and co-inventor of the nicotine skin patch and the e-cigarette
  • Guided by leaders in the field including Dr. Edward Sellers and Professor David Heal
  • Will seek to corroborate preclinical data and demonstrate compelling efficacy, safety and payer narrative
  • Smoking cessation trials will utilize doses of 150/200 mg/day

 

 

 

 

 

 

OTHER LONG-TERM OPPORTUNITIES

 

 

Treatment Resistant Depression – clinical trial demonstrated amitifadine is well tolerated with low incidence of sexual dysfunction and no weight gain. Potential for efficacy in TRD at higher doses and in combination with rapid acting agents

 

Substance Use Disorder – Same paradigm that helps to reduce withdrawal effects in Tobacco Use Disorder is expected to apply here

NEWS

 

ETHISMOS RESEARCH INC. CLOSES DEAL TO ACQUIRE THE INTELLECTUAL PROPERTY ASSETS OF EUTHYMICS BIOSCIENCE INC.

 

–Will Develop Amitifadine, a Serotonin-Preferring Triple Reuptake Inhibitor for Smoking Cessation and other Applications in Addiction and Depression–

 

Cambridge, MA – November 1, 2017

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