Pharmaceutical company AbbVie to buy Gilgamesh depression drug program for up to $1.2 billion; Kentucky committee discusses ibogaine; and Colorado listening session on Natural Medicine Program
Plus: HALT Fentanyl Act could make psychedelic research easier, and Senate veterans committee holds “alternative therapies” hearing
Happy Friday and welcome back to The Microdose, an independent journalism newsletter brought to you by the U.C. Berkeley Center for the Science of Psychedelics.
Pharmaceutical company AbbVie to buy Gilgamesh depression drug program for up to $1.2 billion
As the once-niche psychedelic drug development industry matures, larger pharmaceutical companies are now making investments. Pharmaceutical company AbbVie, known primarily for developing immunology and oncology drugs, announced this week that it has entered into an agreement with psychedelic company Gilgamesh Pharmaceuticals to acquire GM-2505, or bretisilocin, a psychedelic compound Gilgamesh is developing to treat people with moderate to severe major depressive disorder. The drug has been compared to DMT, which produces trips as short as 15 minutes, but GM-2505 has been engineered to provide a slightly longer-lasting trip — around two hours — that still gets patients out of the clinic in less time than a classic psychedelic like LSD or psilocybin, which can last up to 8 hours. AbbVie will acquire the company’s bretisilocin program for up to $1.2 billion, according to its press release.
Gilgamesh announced positive preliminary results from a Phase 2 study of GM-2505 in May. In that clinical trial, 40 participants diagnosed with major depressive disorder received an intravenous infusion of either 10mg or 1mg of GM-2505, alongside “psychological support” — not psychotherapy. Two weeks after that, 70% of participants who received the larger dose of GM-2505 reported large enough decreases in depression symptoms (as measured by the standard depression rating scale MADRS) to be considered in remission.
The deal builds upon a 2024 option-to-license agreement between the two companies, in which AbbVie invested $65 million in Gilgamesh to research novel neuroplastogens. Under the terms of the new deal, Gilgamesh will spin out a new entity called Gilgamesh Pharma Inc. to manage its other psychedelic analogs, including GM-3009, which it’s billing as a “cardiac-safe ibogaine analog,” and GM-1020, an analog of ketamine.
Kentucky committee discusses state support for ibogaine
On Wednesday, the Kentucky Legislature’s Interim Joint Committee on Health Services held a hearing, which included a 30 minute segment discussing ibogaine, a psychoactive substance found in plants including the iboga bush. In February, Kentucky Senator Donald Douglas (R) sponsored a bill proposing that the state establish a fund to study ibogaine as a treatment for addiction. Ultimately, Douglas said in Wednesday’s hearing, he withdrew the bill because there was not enough time left in the legislative session to consider it.
But Douglas added that he intends to introduce new legislation in the state’s next session, and pointed out that Texas recently passed a similar bill. The Texas bill passed largely due to the efforts of Americans for Ibogaine, a nonprofit group advocating for the medicalization of ibogaine in the U.S. The group’s executive director W. Bryan Hubbard initially brought an ibogaine proposal to Kentucky in 2023 when he was serving as the chair of the Kentucky Opioid Abatement Advisory Commission. He suggested earmarking $42 million in state opioid funds for ibogaine research. But when a new state Attorney General took office, he asked Hubbard to resign and the proposal did not advance. (For more, read The Microdose’s 2024 interview with Hubbard following his ousting.)
Hubbard and his colleagues began seeking support in other states, and now that they’ve seen success in Texas, it appears they want to try again in Kentucky — and beyond. Douglas said in the hearing that he’s been in touch with legislators over a dozen other states about the possibility of starting a consortium to fund ibogaine research. The ultimate goal, Douglas said, would be for the federal government to put the drug in a less restricted category; it is currently a Schedule I drug, the U.S. Drug Enforcement Administration’s most restrictive category.
The Kentucky hearing included testimony from two Americans for Ibogaine ambassadors. Jessica Blackburn Allen spoke about her personal experience using ibogaine to treat her addiction to oxycodone and heroin. Jean Loftus, a plastic surgeon practicing in Cincinnati, Ohio, gave an overview of current ibogaine research and an estimate of costs for ibogaine treatment versus traditional therapy. It was not immediately clear where Loftus sourced some of her claims, or how much of a scientific consensus there actually is to support some of those claims.
After Loftus and Allen’s testimony, Douglas made the case for establishing an ibogaine research fund similar to the one recently passed in Texas. “We need to start reaching out to more public-private partnerships here in the Commonwealth, and essentially spreading the wealth,” said Douglas. “Our research institutions do a great job, but I also think we need to develop other areas.” It’s worth noting that Kentucky’s main research university is the University of Kentucky, where addiction researchers have previously raised concerns about working with the drug. In an interview with The Microdose in 2024, when Kentucky was still considering Hubbard’s $42 million ibogaine proposal, University of Kentucky researcher William Stoops told The Microdose that ibogaine’s potential to cause heart arrhythmias could make it difficult for the FDA to grant Investigational New Drug status, which is required for any future clinical trials. He added that such research would require “very specialized private clinical research organization that would allow for a high level of coordinated expertise between specialists like cardiologists, psychologists, psychiatrists” — so public-private partnerships could be effective in supporting this type of work.
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Colorado listening session on Natural Medicine Program
Colorado’s Natural Medicine program has been up and running since the beginning of the calendar year, and on Wednesday, representatives from several Colorado agencies collaborated to hold a public listening session. The meeting included representatives from the Department of Revenue, the Department of Regulatory Agencies, the Department of Public Health and Environment, and the office of Governor Jared Polis (D). (The governor posted about the session on social media.)
The two-hour meeting started with updates from each state agency. Kyle Lambert, Senior Deputy Director of the Department of Revenue’s Natural Medicine Division, said the division was working on a way to track the number of psilocybin administration sessions on an ongoing basis, but that there have been, so far, around 20 sessions held in the state. Allison Robinette, the division’s Director of Policy and Regulatory Affairs, said that they had not seen as many applications as they projected they would: they were expecting 100 licensed businesses in the first year of the program, but have so far only received 64 applications.
Ean Seeb, the governor’s Special Advisor on Cannabis and Natural Medicine, said that Governor Polis’s office has been in touch with federal agencies. According to Seeb, Health and Human Services secretary Robert F. Kennedy, Jr. recently told Polis that he was aware of Colorado’s psilocybin program and promised to “remain outspoken in favor of advancing psychedelic therapies.” Polis’s office has also been in touch with other nations too, including Gabon, to discuss the possibility of the state adding ibogaine to its natural medicine offerings.
With the roughly dozen speakers providing public comment, ibogaine was a big topic of discussion. Many raised their voices to support the state including the drug in its Natural Medicine program. Another major theme was allowing state-licensed testing labs to also test drugs for personal use. “Please consider allowing licensed testing labs to also test personal use products — having as many high-quality labs available to test products serves our community and keeps everyone safer,” said Barine Majewska, an attorney at Vicente, a cannabis and psychedelics law firm. Noah Novello, founder of the drug testing lab Friday Ventures, said he’s found bacteria, including Salmonella and E. coli, in psilocybin samples his lab has tested for personal use, while he said others contain no active compounds at all.
Tasia Poinsatte of the non-profit psychedelic advocacy organization Healing Advocacy Fund pointed out that Oregon, the only other U.S. state with a regulated-access psilocybin program, has just one licensed testing lab. “I think it pretty clearly shows there’s not a lot of incentive to participate as a licensed lab,” she said, adding that Oregon was lucky to still have that lab operational. “I’ve heard it’s been touch and go - there’s been consideration on the part of that lab with leaving the program, so I really hope [this issue] will be taken seriously into consideration.”
Other participants who offered public comment included a veterinarian concerned about accidental psychedelic ingestion by animals, a naturopath worried that people will confuse the state's Natural Medicine Program with the work of naturopaths, and the founder of a cultivation and manufacturing facility with ideas about how to tweak testing requirements to lower costs. Additionally, questioning from one attendee about funding sources for the state’s program revealed that the Psychedelic Science Funders Collaborative has pledged $1.8 million to support the state’s Natural Medicine Program, with the first installment of $100,000 expected to arrive pending contract signing. “We have no reason to doubt that the dollars are coming through,” said Seeb.
HALT Fentanyl Act could make psychedelics research easier
In July, President Trump signed S.331, or the “Halt All Lethal Trafficking (HALT) of Fentanyl” Act. The bill moves all “fentanyl-related substances” to the Controlled Substances Act’s Schedule I, its most restrictive category. But it also proposes changes to rules regarding research involving Schedule I drugs — which might, in turn, make studying psychedelics easier. Specifically, the HALT Fentanyl Act allows for applications to study drugs under investigational use exemptions to undergo an expedited process, and it would allow researchers conducting clinical trials at multiple sites to obtain just one registration with the U.S. Drug Enforcement Administration for their project, rather than having to obtain registrations for each site. In a recent blog post about the legislation, mental health advocacy group BrainFutures writes that “the HALT Fentanyl Act’s reforms could make it more realistic for researchers to expand small pilot studies into large, multi-site trials—the kind needed to move psychedelic therapies closer to FDA approval.”
Senate veterans committee holds “alternative therapies” hearing
Last Friday, the U.S. Senate Committee on Veterans’ Affairs held a hearing in Montevallo, Alabama on potential “alternative therapies” for veterans’ mental health. The hearing included testimony from Ilse Wiechers, the deputy executive director of the Veterans Health Administration’s Office of Mental Health. In her testimony, Wiechers brought up psychedelics as a treatment the VA is considering in treating veterans’ PTSD and alcohol use disorder, and mentioned that the VA also supports the HALT Fentanyl Act as it “allows private, non-governmental entities to expand their controlled Schedule I and II research protocols.” Other therapies she mentioned were hyperbaric oxygen therapy, ketamine and esketamine, transcranial magnetic stimulation, and stellate ganglion block, a procedure typically used to treat nerve pain by injecting an anesthetic into the base of the neck.
The hearing also included testimony from psychedelic company Compass Pathways’ Chief Patient Officer Steve Levine, who spoke about COMP360, the company’s formulation of psilocybin. “Possible FDA approval for certain psychedelic compounds is on the horizon, as there are several ongoing late-stage clinical trials,” Levine said, and went on to make the case for the medicalization of psychedelics: “FDA-approved psychedelics enhance patient safety by ensuring that these drugs have been proven to be safe and effective for specified conditions and patient populations, and that they are prescribed by licensed and trained healthcare professionals for the appropriate patient at the appropriate dose.”
NPR talks with Hunt Priest about how his psilocybin experience in the oft-discussed Johns Hopkins religious professionals study led him to start the Christian psychedelics society Ligare, and Ligare’s former intern Joe Welker’s concerns about it. Welker reported Priest to the church diocese, which launched an investigation — and ultimately, Priest chose to forgo his ordination with the Episcopal church.
Tiny ketamine spoons worn as necklaces are all the rage, reports Mattha Busby for DoubleBlind. “The pocket-sized spoon is steadily becoming an underground countercultural symbol, as recreational consumers push back against a mainstream narrative that largely dismisses the drug,” Busby writes.
Photo by Mattha Busby. “VA Secretary Doug Collins has expressed a willingness to pursue bold, data-driven solutions. Psychedelic-assisted therapy is one such opportunity, backed by science, strengthened by bipartisan support, and gaining momentum among clinicians and veteran advocates alike,” write Congressmen Jack Bergman (R) and Lou Correa (D), and Healing Breakthrough’s Juliana Mercer in a STAT op-ed.
Since 2021, the University of Michigan has hosted Entheofest, a psychedelic festival — but according to Michigan news site MLive, the university has denied the organizers’ permit application for this year’s festival. The organizers have, in turn, filed an appeal.
Denver alt-weekly Westword tells the story of Alexander Vucasovich, who thought his felony conviction for psilocybin possession would be cleared after Governor Polis’s recent announcement that he’d pardon anyone formerly convicted of psilocybin or psilocin possession. But Vucasovich’s case was not dismissed because he was under 21 at the time of his arrest, and no drug was specified in his conviction. Westword reports there were just four people pardoned under Polis’s executive order; Vucasovich has applied for a pardon from the governor’s office but has not yet received one.
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