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Can psychedelic drugs treat depression? Fitchburg institute wants to be leader in the field

Wisconsin State Journal - 9/24/2022

Sep. 24—With cathedral ceilings and spa-like treatment rooms, the $70 millionUsona Institute building going up next to Promega Corp.'s campus in Fitchburg is expected to become a national hub for the use of psychedelic drugs to treat depression and other mental health conditions.

Usona, co-founded by Promega CEO Bill Linton in 2014, is spearheading an effort to get psilocybin, the active ingredient in "magic mushrooms," approved for major depressive disorder. The nonprofit is also providing psilocybin for research on other uses, which may include anxiety, eating disorders, obsessive compulsive disorder, post-traumatic stress disorder and nicotine, alcohol, opioid and methamphetamine addiction.

The institute is developing a synthetic version of 5-MeO-DMT, a psychoactive substance found in the venom of the Sonoran Desert toad, and plans to start the first U.S. study in humans this fall. Usona scientists are also tweaking and screening chemical compounds in an effort to discover other mind-altering drugs that might be therapeutic.

The 93,000-square-foot facility, expected to open in fall 2023 on 17 wooded acres northwest of Promega's headquarters off East Cheryl Parkway, will feature education and training areas for psychedelic drug researchers and providers from around the country.

In a floating pool, sauna, steam room and botanical room, patients will be able to prepare themselves for guided, hallucinogenic experiences in serene spaces, with the goal of helping them break free from the grip of mental anguish. Three residential cottages are planned.

"Their hope is for some sort of personal transformation," Linton said. "It's my belief that people are undergoing a change in self-awareness, a re-set of 'who am I?'"

The development of a headquarters for Usona, now housed in other Promega buildings, comes amid a growing national profile for psychoactive medicine. It's a comeback of sorts, after studies of psilobycin, LSD and other psychedelics for mental disorders in the 1960s were stopped after what were considered excesses of recreational use resulted in the drugs becoming illegal in 1970.

Now, Johns Hopkins University has received a $4 million grant from the National Institute on Drug Abuse to study psilocybin for tobacco addiction, after an initial study found higher quit rates than for other smoking cessation techniques. At New York University, where a study published in August found psilocybin can help treat alcoholism, the National Cancer Institute is funding a large study of psilocybin for depression and distress among patients with advanced cancer.

By the first half of 2024, the Food and Drug Administration is expected to approve MDMA, sometimes called Ecstasy or Molly, for PTSD, federal officials said in May.

The drugs act on specific brain receptors to change perception and cognition, with psilocybin having a very low risk of addiction because it doesn't seem to involve the addictive reward circuitry of the brain, scientists say. The benefits can come from just one or two doses.

"There has been a resurgence, I think, of the interest in psychedelic drugs, which for a while were sort of considered not an area that researchers legitimately ought to go after," Dr. Francis Collins, then-director of the National Institutes of Health, said during a U.S. Senate budget hearing last year. "I think as we've learned more about how the brain works, we've begun to realize that these are potential tools for research purposes and might be clinically beneficial."

Transformative experience

It was a friend's relief from depression during late-stage cancer that got Linton tuned into the psychedelic revival. In a study at Johns Hopkins, the friend, whom Linton identifies publicly only as Betty, took psilocybin and was transformed, he said. The experience greatly improved her life and her family's lives during the few months before she died, he said.

"Her whole demeanor changed," Linton said. "She went from this state of deep depression to a sense of gratitude, feeling that each day was a gift."

Linton and Dr. Malynn Utzinger, a family medicine and integrative medicine provider who graduated from the UW School of Medicine and Public Health, created Usona to shepherd psilocybin through the multi-phase clinical trial process required for FDA approval.

After an initial study of a dozen healthy people at UW-Madison found no significant side effects, Usona sponsored a phase 2 trial involving 100 people with major depression at UW-Madison and six other sites, including Johns Hopkins and NYU. Results are expected soon, with plans to start a larger phase 3 study late next year before seeking FDA approval, which Linton said could come by 2025.

Usona expects to start a phase 1 study of 5-MeO-DMT, the toad compound, in Kansas City in November. While recreational use of the substance and studies in Europe have involved inhaling it as a vapor, Linton said Usona's approach is an injection into the arm.

Studies have suggested 5-MeO-DMT might have benefits for anxiety, depression and stress, but it's not clear what condition Usona will target. "We believe it offers a lot of therapeutic potential, but we haven't decided what that indication is going to be," Linton said.

Usona's synthetic versions of psilocybin and 5-MeO-DMT have been manufactured in Northern Ireland. But production is being transferred to Promega's new Chappelle Manufacturing Center, on Sub-Zero Parkway about three miles west of Promega headquarters. The facility can make psilocybin, 5-MeO-DMT and other compounds in clean-room conditions required for commercial use.

Scaling up

In Usona's research and development lab at Promega, medicinal chemist Alex Sherwood and his colleagues are synthesizing metabolites of psilocybin and 5-MeO-DMT to be used as references in the analysis of blood samples from clinical study participants.

In an effort to understand the mechanisms of action of psychedelics to develop improved drugs, they're studying MDMA, LSD, mescaline and other psychoactive substances, synthesizing reconfigured compounds and participating in the National Institute of Mental Health's Psychoactive Drug Screening Program.

"The goal of this lab is to produce small amounts of many things," Sherwood said.

Next door, Sam Williamson is refining ways of making large quantities of psilocybin and 5-MeO-DMT.

"The idea is to have the perfect process to make these huge, massive batches," said Williamson, a process development research scientist.

In 2020, Usona scientists published their process for synthesizing psilocybin, allowing others to produce their own supply for research. Scientists can also obtain psilocybin for studies from Usona at minimal cost. Usona provides psilocybin, 5-MeO-DMT and other compounds to some 120 research centers around the world.

Last year, Usona started Porta Sophia, an online library of research findings and other information on psilocybin and other psychedelics, to show patent seekers and examiners what is already in the public domain.

London-based Compass Pathways, a for-profit company that has conducted a large study of psilocybin for depression, has five U.S. patents on a form of psilocybin. A nonprofit founded by a former Usona board member challenged two of the patents in December, but an appeals board upheld them in June.

Porta Sophia has challenged numerous claims in Compass patent applications. They include some describing the setting in which psilocybin is given, such as the patient using an eye mask and being in a room with muted colors and soft furniture. The company recently canceled those claims.

"We support good patents, on things that are truly innovative," Linton said.

Denver became the first U.S. city to effectively decriminalize psilocybin in 2019, with 10 other cities and the state of Oregon now having taken that step or made possession of small amounts the lowest law enforcement priority, according to Psychedelic Alpha.

While Linton supports decriminalization, he said Usona and its new facility are focused on helping people with major depression, with which an estimated 21 million Americans have at least one episode each year.

"This is the first center ... specifically designed with this in mind," Linton said. "It offers an opportunity for that change to occur with one single treatment, which is quite remarkable."


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