Ibogaine Advocates Seek Ohio Opioid Settlement Funds Following Failure in Kentucky

As we mentioned in our coverage of the Kentucky effort, bringing a drug through the FDA approval process is expensive, with costs often measured in the hundreds of millions or even billions of dollars. Kentucky’s $42 million proposed carve-out, then, seemed to dwindle in comparison to this sum.What’s more, given ibogaine’s exceedingly long duration of effects, even when compared to other psychedelics, and cardiac risk profile (Nolan Williams told Tim Ferriss that the drug has a “roughly 1 in 300 chance of death”), it’s likely to be a particularly difficult drug to develop.Indeed, Hubbard admitted that, “as was the case in Kentucky, this is an aspirational endeavour.”Outside of this initiative in Ohio, a number of for-profit efforts to develop ibogaine into an FDA-approved drug are underway.DemeRx IB, an atai Life Sciences program, is developing its ibogaine candidate (DMX-1002) in OUD, for example.But, as we reported last August, Phase I results from DemeRx’s study of its ibogaine candidate being developed for OUD were a bit of a damp squib. While the clinical trial registry entry for the study included four potential doses (3, 6, 9, and 12 mg/kg), the 12 mg/kg dose was not mentioned in a press release which briefly described the results. An ibogaine practitioner who spoke with Psychedelic Alpha suggested that doses in excess of 10 mg/kg are regularly employed in the unregulated space, especially in individuals with substance use disorders. If this is the case, DemeRx’s Phase I data might not be so useful for those looking to employ higher doses in later-stage trials.Gilgamesh Pharmaceutical is also developing ibogaine-related drugs. Its GM-3009 candidate, is a “novel cardiac safe Ibogaine analog” which has been, “designed based upon >15 years of research on the pharmacology and medicinal chemistry of ibogaine”, the company told Psychedelic Alpha. The candidate, which is yet to reach in-human studies, is protected by composition of matter intellectual property, Gilgamesh added.And, as we noted in our contemporary coverage (see Pα+ Psychedelic Bulletin #153), some of the co-authors of the Stanford study, including Nolan Williams, are listed as inventors on two unpublished patent applications related to the therapeutic use of ibogaine.Despite this commercial activity, the fact remains that there is a dearth of published clinical trial data on the compound. As such, it’s likely that any Ohio-driven effort will have to start from a very early phase of development.OSU researcher Alan Davis and DemeRx’s founder Deborah Mash, however, have devised a plan that they think will allow them to leapfrog to Phase II.“It’s going to remain an expensive and time consuming endeavor without better real-world data on the risks and benefits associated with ibogaine treatment”, Davis told us, “which is why I’ve partnered with Dr. Deborah Mash on the first global ibogaine patient survey.”The Ibogaine Patient Survey aims to collect self-reported data from people who have taken ibogaine as an intended treatment for addiction or other disorders. That data, Davis hopes, “will be used to help establish better estimates of ibogaine safety for future FDA submissions.”



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