Noribogaine is a Potential Breakthrough Treatment for Alcoholism Harnessing Benefits of Ibogaine While Removing Psychedelic Side Effects
MIAMI, FLORIDA, USA, August 8, 2024 /EINPresswire.com/ — DemeRx NB, Inc., a company dedicated to developing new medications for alcohol and drug addiction, has started screening healthy volunteers for a study on a potential treatment for Alcohol Use Disorder (AUD). They are testing a medication called DMX-1001 in a Phase 1b clinical trial.
In this study, the first group of participants will take either a 10mg 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 40mg. 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 an effective 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)
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.
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 unwanted side 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.
Tim Sullivan
DemeRx NB Inc.
+1 732-954-5100
T3Shamrock@gmail.com
Visit us on social media:
LinkedIn
