DemeRx Doses First Subject in Phase 1/2a Study of DMX-1002 (Ibogaine) in Opioid Use Disorder
DemeRx IB, Inc. (“DemeRx”), an atai Life Sciences (NASDAQ: ATAI) platform company focused on developing ibogaine for the treatment of opioid use disorder (OUD), today announced that the first subjects have been dosed in a Phase 1/2a clinical trial of ibogaine HCl (DMX-1002). The trial has commenced enrollment and dosing of recreational drug users and healthy volunteers in the Phase 1 segment of the study at the Manchester clinical unit of MAC Clinical Research (MAC) in the UK, one of Europe’s largest clinical development organizations.
DMX-1002 is an oral formulation of ibogaine, a naturally occurring psychedelic product isolated from a West African shrub. In previously published non-controlled studies, ibogaine has demonstrated rapid and sustained efficacy in treating OUD and has the potential to be a disease modifying treatment for this vulnerable patient population seeking to end their intractable cycle of drug dependence.
The Phase 1/2a trial is designed to assess safety, tolerability, pharmacokinetics, and efficacy, and the results will inform future studies in patients with opioid use disorder. We expect to obtain safety data from the phase 1 segment of this trial in early 2022.
“By launching the Phase1/2a trial, we look forward to bringing important data from carefully designed, controlled studies to the existing literature on ibogaine, a compound with substantial history,” said Dr. Deborah Mash, CEO and President of DemeRx. “We are hopeful that this early trial can begin to establish a safe and efficacious profile for Ibogaine, so that we can potentially offer a new option for patients seeking to break free from OUD who have far too few options.”
“The opioid crisis has ravaged the U.S. for over 20 years with little sign of letting up. The COVID-19 pandemic revealed the tragic vulnerability of people addicted to drugs as the CDC tallied 93,000 drug overdose deaths in 2020, a 30% increase, 70,000 of which involved opioids,” added Srinivas Rao, Chief Scientific Officer and Co-founder of atai Life Sciences. “Launching our Phase 1/2a trial of ibogaine with assent of regulators, we believe is a major step towards reversing the trend of the opioid crisis.”
We strive for bold innovation to address the global crisis of mental health. By launching this Phase 1/2a trial, we are grateful for the work of our dedicated teams at DemeRx and atai who are committed to this ethos, striving to bring transformative treatments through rigorous testing.
Florian Brand, Chief Executive Officer and Co-founder of atai Life Sciences
About DemeRx, Inc. & DMX-1002
DemeRx, Inc. is a Miami-based clinical stage pharmaceutical company focused on developing ibogaine and noribogaine for the treatment of OUD. DemeRx’s mission is to advance the development of potential treatments for OUD in order to prevent patient suffering, provide better treatment retention, and decrease illegal opioid use.
DemeRx is developing DMX-1002 for the treatment of OUD. DMX-1002 is a GMP drug product manufactured for human use.
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