DemeRx’s Neuroplastogen Candidate Signals New Alcohol Use Disorder Approach

Stop alcohol concept. Person refuse to drink alcohol. | Image Credit: © Pormezz - stock.adobe.com

Miami-based clinical-stage biopharmaceutical company DemeRx has been awarded a $1.7 million Small Business Innovation Research grant from the National Institute on Alcohol Abuse and Alcoholism, part of the United States National Institutes of Health, aimed at advancing DemeRx’s neuroplastogen drug candidate DMX-1001 (noribogaine) (1). The funding, according to an Oct. 7, 2025 press release, is designed to move DemeRx’s candidate through necessary investigational new drug-enabling studies and toward Phase II clinical trials for treatment of alcohol use disorder (AUD).

How does the noribogaine treatment work?

DemeRx said that its noribogaine candidate takes a novel therapeutic approach of targeting multiple central nervous system areas, with a desired result of rapid intervention that reduces not only cravings, but also the compulsion to drink alcohol (1). Because the treatment additionally promotes neuroplasticity, it works to normalize neurotransmitter signaling, lowering a risk of relapse and potentially reversing long-term effects of AUD.

A Phase Ib trial evaluating the pharmacokinetics, pharmacodynamics, and safety of multiple ascending doses of DMX-1001 has been completed, DemeRx said (1). In previous Phase I trials, it was well-tolerated and found to be safe.

What is AUD, and who is affected?

According to multiple sources cited by DemeRx, AUD impacts more than 29 million people in the US and is a leading cause of preventable death (1). While fewer than 5% of the population said to be affected by AUD receives medication, approximately 60% of those who are treated relapse to a hazardous level of drinking within six months.

"Alcohol use disorder affects many American families, and current therapeutic options remain limited,” Deborah Mash, PhD, CEO and founder of DemeRx, said in the company’s press release (1). “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."

What uses have other neuroplastogen treatments had?

In June 2025, news came that two other neuroplastogen candidates were advancing. Psilera, a biotechnology company with a focus on developing therapies for difficult-to-treat neurological disorders, and Hesperos, which specializes in organ-on-a-chip technology, announced a strategic agreement to accelerate preclinical development of Psilera’s lead compound, PSIL-006, which integrates next-generation neuroplastogen to target frontotemporal dementia (2).

Elsewhere, the Franco-Belgian biotech venture Elkedonia raised €11.25 million (US$13.1 million) in an oversubscribed seed round to advance a first-in-class neuroplastogen that targets the intracellular protein Elk1, aiming to restore neuroplasticity—without the drawbacks of current options like psychedelics or ketamine derivatives—to address the challenge of treatment-resistant depression (3).

DemeRx expects that the outcomes of its Phase Ib trial, which was conducted in healthy volunteers, will inform the progression of its noribogaine candidate into its Phase II study, involving patients with AUD (1).

References

1. DemeRx. 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). Press Release. Oct. 7, 2025.
2. Hesperos. Psilera Collaborates with Drug Development Leader Hesperos to Advance Preclinical Modeling of PSIL-006 for Frontotemporal Dementia. Press Release. June 9, 2025.
3. Cole, C. Elkedonia Raises €11.25M Seed Round to Advance Neuroplastogen Therapy for Depression. PharmTech.com, June 11, 2025.