A joint venture has been set up by ATAI Life Sciences and DemeRX to develop a one and done treatment that will work to give people suffering from addiction a neurochemical reset of sorts using a drug derived from a Western African plant.
The $22 million investment from ATAI will develop the drug ibogaine which is derived from the iboga plant that has previously been sold as a stimulant and antidepressant in France, as well as being studied in other countries as a possible treatment for addiction. One of those studies included a large on led by DemeRx CEO Deborah Mash, Ph.D; now DemeRx and ATAI are hoping to get regulatory approval to start a clinical trial so they can bring the drug candidate into phase 2 trials in order to further investigate and prove its benefits in a more controlled clinical setting.
“We want to move quickly to an efficacy study so we can demonstrate what hundreds and hundreds of patients already know,” Mash said. While not a cure, this would be “powerful first step on the road to recovery.”
Mash traveled to Amsterdam to see what the drug could do firsthand, “It was an absolutely gentle detox with no withdrawals. I saw immediately the efficacy of this treatment, that a single dose was able to get people through withdrawal, to have this kind of ‘aha’ moment about their self-destructive behavior. To gain insights on what was driving them and what got them into this addiction habit to begin with,” she said.
Mash then conducted an open label study to investigate the drug in 102 participants who were dependent on opioids and 89 who were dependent on cocaine. 1 low oral dose of ibogaine was found to be enough to reduce opioid withdrawal scores only 36 hours after treatment, and was also enough to tamp down the severity of cravings as well as depression in both groups.
According to the researchers ibogaine affects multiple neurotransmitter systems, with the exact mechanisms being unclear, but it does promote a dreamlike state in patients that plays a role in interrupting addiction. It is believed that this is a neurochemical reset that provides patients a window during which they will have no cravings or desire to use opioids, thus having an improved chance at successful recovery.
“It makes more patients treatment ready, so they will be ready to succeed with whatever therapy they choose—rehabilitative therapy, inpatient, outpatient, case management, 12-step groups, or going on methadone,” Mash said.
The substantial investment from ATAI should be enough to push ibogaine through critical milestones including a double blind placebo controlled randomized study and investigations to understand what dosing will be. The joint venture will also be developing a treatment protocol that will include screening guidelines as the drug has been linked to heart side effects and may not be appropriate for those with cardiovascular conditions.