“The goal of the trial is to gather data on the safety, tolerability, and how the body processes the medication in healthy individuals. This study will help determine if DMX-1001 could be a well-tolerated treatment for Alcohol Use Disorder,” said CEO Deborah Mash, Ph.D.

Miami - July 29, 2024 - DemeRx NB, Inc., a company dedicated to developing new medications for alcohol and drug addiction, has started enrollment of healthy volunteers in an oral dose study of a potential treatment for Alcohol Use Disorder (AUD). DemeRx is testing a medication called DMX-1001 in a Phase 1 clinical trial. DMX-1001, also called noribogaine, is a patented molecule that is an active drug metabolite of ibogaine. Noribogaine is different from ibogaine in that it does not have the observed psychedelic side effects that risk diversion, misuse and other safety concerns. 

In this study, the first group of participants will take either a 10 mg dose of DMX-1001 or a placebo twice a day for a week. The total number of subjects will be up to 60, divided into four groups. The maximum daily dose of DMX-1001 in the study will be 80 mg. Dr. Deborah Mash, CEO of DemeRx NB, stated that this study will provide important information for planning the next phase of research.

“The goal of the trial is to gather data on the safety, tolerability, and how the body processes the medication in healthy individuals. This study will help determine if DMX-1001 could be a well tolerated treatment for AUD,” said CEO Deborah Mash, Ph.D.

About AUD

The significance of this study lies in the potential public health implications of a new, effective treatment for Alcohol Use Disorder. Alcohol Use Disorder (AUD) is a significant public health concern in the United States, with alcohol-related causes contributing to a staggering  95,000 deaths annually, according to data from the Substance Abuse and Mental Health Services Administration (SAMHSA)

AUD is often associated with various comorbidities, such as mental health disorders, liver disease, cardiovascular problems, and increased risk of accidents and injuries. SAMHSA data shows that individuals with AUD are more likely to experience co-occurring mental health issues, further complicating their overall health and well-being.

The economic burden of Alcohol Use Disorder is substantial, with healthcare costs related to the disorder estimated to be in the range of billions of dollars annually. SAMHSA data indicates that the healthcare expenses for treating AUD, including medical interventions, rehabilitation programs, and hospitalizations, place a significant financial strain on the healthcare system.

Furthermore, the indirect costs of AUD, such as lost productivity in the workforce, are also considerable. SAMHSA data highlights the impact of AUD on workplace productivity, absenteeism, and reduced efficiency, resulting in billions of dollars in lost productivity costs each year. Addressing the scale and scope of AUD in the USA not only requires a focus on improving individual health outcomes but also necessitates comprehensive strategies to mitigate the economic and societal consequences of this pervasive disorder.

Public Health Implications of DM-1001

Despite the scale and urgency of the public health problems caused by AUD, new therapeutic agents have not progressed, and relapse rates in patients are high. This study of DMX-1001 represents a current shift in therapeutic strategy for complex brain disorders to focus less on rectifying single target “chemical imbalances” and more towards selective modulation of neural circuits. DMX-1001 interacts with two or more CNS targets simultaneously and the drug has demonstrated predictive validity in animal models of AUD.

By targeting specific brain circuits involved in addiction, if successful, DMX-1001 could provide hope for those struggling with Alcohol Use Disorder and help reduce the burden of alcohol addiction on individuals and society as a whole. The availability of a new and effective treatment for AUD would have a profoundly positive effect on public health, reducing suffering and alcohol related diseases and deaths.

Moreover, DMX-1001 represents a breakthrough in the field by aiming to remove the psychedelic effects associated with ibogaine, a compound known for its potential in treating addiction but limited by its hallucinogenic properties. By developing a medication that retains the therapeutic benefits of ibogaine while eliminating the psychedelic effects, DemeRx NB is paving the way for a safer and more widely applicable treatment for AUD.

About DM-1001

DMX-1001 is a new chemical entity azepinoindole that fits into a category of novel “psychoplastogen” therapeutic agents. Administration of DMX-1001 has shown proof of concept in preclinical models of alcohol, opioid, cocaine and nicotine addictions. DemeRx has completed three Phase 1 pharmacokinetic studies of DMX-1001. The Phase 1 pharmacokinetic studies demonstrated that DMX-1001 has a favorable safety and pharmacokinetic profile. DMX-1001 was well-tolerated with no serious adverse events reported and plasma exposure was approximately linear across the doses tested in these studies. Overall, these trials suggest that DMX-1001 can be safely administered orally at various doses and has the potential for long-acting effects in addiction treatment. In the MAD study, participants will be assigned to one of the four possible cohorts. Each participant will receive DMX-1001 or placebo capsules twice daily for 7 days with a final dose on the morning of day 8. Topline data from the fourth cohort is anticipated in Q1 2025.

About DemeRx NB, Inc.

DemeRx NB, Inc. is a clinical stage biopharmaceutical company focused on the discovery and development of innovative medicines for the treatment of addiction. DemeRx NB has leveraged its expertise to optimize clinical trial design to advance dose selection of DMX-1001 for testing in a Phase 2 trial for the treatment of AUD.  DemeRx NB, Inc. maintains its corporate headquarters in Miami, FL. 

Forward-Looking Statements

Statements contained in this presentation regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements associated with the Company's DMX-1001 program, the expected timing for initiating clinical studies, potentially achieving therapeutic efficacy and clinical translation for ADPKD patients, the expected timing for reporting topline data, the timing and future occurrence of other preclinical and clinical activities and the expected length of our cash runway. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "intends," "will," "goal," "potential" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Regulus' current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, the approach we are taking to discover and develop drugs is novel and may never lead to marketable products, preliminary or initial results may not be indicative of future results, preclinical and clinical studies may not be successful, risks related to regulatory review and approval, risks related to our reliance on third-party collaborators and other third parties, risks related to intellectual property, risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics and in the endeavor of building a business around such drugs, and the risk additional toxicology data may be negative and our need for additional capital. 

For more details about the clinical trial and the potential impact of DMX-1001, you can visit clinicaltrials.gov. 

For more information or to arrange interviews, contact:

Tim Sullivan 
T3Shamrock@gmail.com
732 954 5100

Media Contact
Company Name: DemeRx NB Inc.
Contact Person: Tim Sullivan
Email: Send Email
Country: United States
Website: www.demerx.com