DemeRx Announces Successful Completion of Multiple Ascending Dose Clinical Trial of DMX-1001 for the Treatment of Alcohol Use Disorder (AUD)

• Phase 1 data for DMX-1001 (noribogaine) support advancement into Phase 2 clinical trial in AUD

• AUD affects more than 29 million Americans and is a leading cause of preventable death; about 60 percent of patients treated for AUD relapse to hazardous drinking within six months

MIAMI--(BUSINESS WIRE)--DemeRx, Inc., a clinical-stage biopharmaceutical company dedicated to transforming addiction therapeutics, today announced positive results from its Phase 1 multiple ascending dose (MAD) study of DMX-1001 (oral noribogaine) for the treatment of alcohol use disorder (AUD). The results demonstrated safety, tolerability, and pharmacokinetics that support advancing DMX-1001 to Phase 2 clinical trials in people with AUD.

The Phase 1 clinical trial was a double-blind, placebo-controlled study evaluating DMX-1001 in a total of 55 healthy volunteers randomized to receive multiple ascending doses from 20 mg up to 80 mg daily dose. Results showed DMX-1001 was safe and well-tolerated. Cardiac safety assessments showed normal vitals and a dose-related effect of the drug on the heart-rate corrected QT interval which was not considered clinically relevant.

“Alcohol use disorder is a national public health concern. The treatment landscape for AUD is desperate for a disruptive therapeutic that offers durability,” said Deborah Mash, Ph.D., CEO and founder of DemeRx. ”With DMX-1001, we aim to break the cycle of relapse by providing a neurorestorative treatment for patients. We are not just treating symptoms but aiming to restore brain health.”

“These results from our MAD study give us confidence that we have the safety data needed to de-risk Phase 2 development of DMX-1001. We look forward to progressing the clinical program for DMX-1001 in AUD to provide better medicines for patients struggling with addiction to alcohol and drugs,” said Dr. Mash.

DMX-1001 represents a novel therapeutic approach that uniquely combines neuroplasticity and polypharmacology mechanisms of action. It acts as a neuroplastogen, increasing glial-derived neurotrophic growth factor (GDNF), which helps regulate dopamine levels to restore balance in the brain's reward system. Additionally, DMX-1001 has rapid antidepressant and anti-anxiety effects. AUD is often associated with mental health disorders, including depression and anxiety which increase the risk of relapse for people in early recovery.

Alcohol use disorder affects more than 29 million people in the United States and is a leading cause of preventable death. Alarmingly, fewer than five percent of those suffering from AUD receive medication, and approximately 60 percent of treated patients relapse to hazardous drinking within six months.^1,2,3,4

About DemeRx, Inc.

DemeRx, Inc. is a pioneering clinical-stage biopharmaceutical company dedicated to transforming addiction therapeutics and improving outcomes for individuals facing substance use disorders. Leveraging advanced scientific research and strategic clinical initiatives, DemeRx focuses on DMX-1001 (oral noribogaine) as a groundbreaking solution for alcohol use disorder. For more information about DemeRx, please visit http://www.demerx.com.

Sources

1. 2023 National Survey on Drug Use and Health (NSDUH) SAMHSA, Center for Behavioral Health Statistics and Quality. 2022 National Survey on Drug Use and Health. Table 5.9A—Alcohol use disorder in past year: among people aged 12 or older; by age group and demographic characteristics, numbers in thousands, 2022 and 2023. [cited 2024 Aug 2]. Available from: https://www.samhsa.gov/data/report/2023-nsduh-detailed-tables
2. CDC. Alcohol and Public Health: Alcohol-Related Disease Impact. [Table], Annual average for United States 2020–2021 alcohol-attributable deaths due to excessive alcohol use, all ages. [cited 2024 Mar 13]. Available from: https://nccd.cdc.gov/DPH_ARDI/Default/Report.aspx?T=AAM&P=F1F85724-AEC5-4421-BC88-3E8899866842&R=EACE3036-77C9-4893-9F93-17A5E1FEBE01&M=7F40785C-D481-440A-970F-50EFBD21B35B&F=&D=
3. NIAAA: https://www.niaaa.nih.gov/alcohols-effects-health/alcohol-topics/alcohol-facts-and-statistics/alcohol-treatment-united-states#:~:text=Among%20an%20estimated%2028.9%20million,AUD%20in%20the%20past%20year.&text=Among%20an%20estimated%20757%2C000%20youth,AUD%20in%20the%20past%20year.&text=Among%20an%20estimated%2028.1%20million,AUD%20in%20the%20past%20year.&text=According%20to%20the%20Substance%20Abuse,Definitions%20report%20for%20more%20details
4. Stillman M, Sutcliff J. Predictors of relapse in alcohol use disorder: identifying individuals most vulnerable to relapse. Addict Subst Abus. 2022;1(1):3–8. doi: 10.46439/addiction.1.002.