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First in Human: Early research shows safety of psilocybin as interest grows


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First in Human: Early research shows safety of psilocybin as interest grows

This is a recurring column on clinical research in the early stages of development, what is referred to as phase 1. These are treatments that are being used for the first time in a small number of human patients to determine safety, dosing and general pharmacological activity.

SNL Image

Safety of psilocybin use

Researchers with King's College London found no adverse effects in participants who consumed the psychedelic substance psilocybin during an early-stage clinical trial, opening the door for research in the substance's ability to treat psychiatric conditions.

Participants in the study were given doses of psilocybin — the hallucinogenic substance sometimes referred to as "magic mushrooms" — coupled with one-on-one counseling over a four- to six-hour intoxication period. No adverse emotional or cognitive effects were observed compared to patients given a placebo, according to a Dec. 12 press release from COMPASS Pathways Ltd., a U.K.-based mental healthcare company that conducted the phase 1 study.

James Rucker, lead investigator on the study, said in an interview that the study was the first step in a long process, but the results showed people can safely consume the substance in a controlled setting with trained specialists. Rucker is the senior clinical lecturer in psychopharmacology at King's College London's Institute of Psychiatry, Psychology and Neuroscience.

"From a medical perspective, [psilocybin is] not a concerning drug to use," Rucker said. "It's physiologically benign."

Treatment with psilocybin can be complex because of the counseling component and possible unexpected psychological reactions in patients, according to Rucker. However, of the 89 healthy volunteers that participated, only one had to be given what Rucker called a rescue medication, which was a small dose of a benzodiazepine.

Rucker, who has worked on a previous study examining psilocybin's effect on patients with depression, said healthcare professionals are now more accepting of psilocybin and other psychedelic substances as legitimate treatment options than in years past.

"There's something about a dissatisfaction with established treatments for mood disorders and looking for a different paradigm to help people who are not benefiting from established treatment," Rucker said.

SNL ImageExperts believe that psilocybin, the hallucinogenic substance in what is sometimes called "magic mushrooms," could be an effective treatment for patients with mood disorders such as
major depressive disorder.
Source: AP Photo

Psilocybin may also be an option for drug development in mood disorders, which have not seen major innovation in decades, according to Rucker. However, due to the therapy component coupled with the drug, Rucker said the substance may be difficult to fit into a pipeline.

Johnson & Johnson's esketamine nasal spray for treatment-resistant depression was approved in March, with the label requiring the medicine be self-administered by patients in a clinic setting. Ketamine and other psychedelic substances are being investigated for difficult-to-treat psychiatric conditions with counseling components as well.

Matthew Johnson, associate professor of psychiatry and behavioral sciences at Johns Hopkins University's School of Medicine and associate director of the Johns Hopkins Center for Psychedelic and Consciousness Research, said in an interview that along with the growing interest in the healthcare industry, psilocybin is also attracting the attention of government regulators like the U.S. Food and Drug Administration.

Johnson said that he has spoken with FDA officials about the clinical promise of psilocybin and is confident the agency is taking its potential very seriously. He said a collection of phase 3 studies are needed to show positive treatment effects for the drug to earn FDA approval for medical use, but he believes that could occur in the next five to seven years.

Rucker is working with Compass Pathways on a phase 2b study examining psilocybin's effect on patients with depression that have not responded to medication.

As interest in psychedelic substances continues to build, Rucker stressed that further activity and progression in this space should be done "mindfully."

"I feel this is a bit like a coiled spring, there is a lot of potential," Rucker said. "The question ... for both us as researchers and us as a society, is how we release that potential and control that potential."

Once-daily depression drug

Clinical-stage biopharmaceutical company Tonix Pharmaceuticals Holding Corp. could be one step closer to developing a new once-daily drug for depression.

The New-York based company tested a controlled release tablet of tianeptine oxalate, called TNX-601 CR, in a phase 1 trial, with plans to develop the drug for major depressive disorder and post-traumatic stress disorder.

Tianeptine oxalate was discovered by Toxin and is a new formulation of tianeptine, a generic drug sold under a number of brand names including Stablon and Coaxil.

The trial examined 12 male and female participants over six dosing periods, comparing TNX-601 and other prototype tablets to Stablon immediate response tablets. Participants tolerated the drug well, and side effects were consistent with previous findings of tianeptine sodium, which is approved for depression treatment in Europe, Russia, Asia and Latin America, according to a Dec. 16 press release from Tonix.

President and CEO Seth Lederman is confident the market has space for the once-daily drug, saying in a press release that "despite multiple approved products in the U.S., there remains significant interest in new treatments."

The U.S. has not approved a tianeptine-containing drug before, and no controlled-release tianeptine product have been approved in any jurisdiction.