DemeRx Awarded $1.7 Million National Institutes of Health Grant to Advance Potential First-in-Class Neuroplastogen Drug Candidate DMX-1001 for Alcohol Use Disorder (AUD)

DemeRx Awarded $1.7 Million National Institutes of Health Grant to Advance Potential First-in-Class Neuroplastogen Drug Candidate DMX-1001 for Alcohol Use Disorder (AUD)

  • DMX-1001 (noribogaine) is being developed to treat AUD through a potential novel mechanism that targets multiple areas of the central nervous system and promotes neuroplasticity
  • AUD impacts more than 29 million Americans1 and is a leading cause of preventable death
  • Phase 1b clinical trial for DMX-1001 completed; results to inform target dose selection for Phase 2 clinical trials

MIAMI–(BUSINESS WIRE)–DemeRx, Inc., a clinical-stage biopharmaceutical company dedicated to transforming addiction therapeutics, today announced it was awarded a $1.7 million Small Business Innovation Research (SBIR) Grant from the National Institute on Alcohol Abuse and Alcoholism (NIAAA) at the National Institutes of Health (NIH). This funding will help advance DemeRx’s promising neuroplastogen drug candidate, DMX-1001 (noribogaine), through the necessary IND-enabling studies and toward Phase 2 clinical trials for the treatment of Alcohol Use Disorder (AUD).

“We are immensely grateful to the NIAAA for their support of our work in developing DMX-1001,” said Deborah Mash, Ph.D., CEO and founder of DemeRx. “Alcohol use disorder affects many American families, and current therapeutic options remain limited. The high rates of relapse highlight the urgent need for effective treatments. This grant not only validates our therapeutic approach but also underscores the potential of DMX-1001 to offer a transformative solution for those seeking treatment.”

AUD affects more than 29 million people in the United States and is a leading cause of preventable death. 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

DMX-1001 represents a novel therapeutic approach by targeting multiple areas of the central nervous system. DMX-1001 aims for a rapid intervention that effectively reduces cravings and the compulsion to drink. It also promotes neuroplasticity, which may reverse the long-term detrimental effects of AUD and lower the risk of relapse by normalizing neurotransmitter signaling. In Phase 1 clinical trials, DMX-1001 was found to be safe and well-tolerated.

DemeRx has completed a Phase 1b clinical trial to evaluate the pharmacokinetics, pharmacodynamics, and safety of multiple ascending doses of DMX-1001 in healthy volunteers. The outcomes of this clinical trial will inform the progression of DMX-1001 into a Phase 2 study involving patients with AUD.

This grant is supported by the NIAAA under Award Number FAIN# R43AA032127.

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 (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.

Contacts

Media contact:
Greig Communications
Kathy Vincent
kathy@greigcommunications.com

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