Trial Testing Psilocybin in Parkinson’s Nears End

Silo Pharma research at UCSF also targets bipolar disorder, chronic pain

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by Steve Bryson, PhD |

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A clinical trial testing the impact of low doses of psilocybin, a naturally occurring psychedelic compound, on inflammatory activity in people with Parkinson’s disease is on track to be completed by the end of February.

Sponsored by Silo Pharma and conducted at the Clinical & Translational Science Institute (CTSI) at the University of California, San Francisco (UCSF), the study also will include two other patient populations.

These comprise people with chronic pain and those with bipolar disorder, a mental health condition characterized by extreme mood swings. Data collection on the bipolar patients is set to begin soon, and the chronic pain  portion will begin in April.

“The UCSF research team is making progress on the clinical trial,” Eric Weisblum, Silo’s CEO, said in a press release.

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“Utilizing Psilocybin in this study in a regimented dosing pattern, we hope to gain significant data both in mechanism of action and potential biomarker for personalization of psilocybin therapy,” Weisblum added. “The data gathered from these studies could uncover the role of inflammatory activity on such conditions as Parkinson’s, bipolar disorder, and chronic pain.”

Produced by several species of fungi, psilocybin is the psychoactive substance in so-called “magic mushrooms” that alters perception, mood, and numerous cognitive processes.

Despite these effects, low doses of psilocybin have been evaluated as potential therapies for various mental health conditions, including cognitive impairment, anxiety, and depression.

In 2020, Silo announced plans to study low-dose psilocybin in a Phase 2b clinical trial to assess its impact on cognitive and emotional impairment in Parkinson’s.

As part of its Translational Psychedelic Research Program, UCSF also is recruiting about 10 early-stage Parkinson’s patients, ages 40–75, for a pilot study (NCT04932434) to evaluate psilocybin therapy for depression and anxiety.

In the Silo trial investigating psilocybin’s potential to reduce inflammation in the three patient populations, participants will undergo preparation sessions, two sessions with psilocybin dosing, and integration sessions.

Preparation sessions aim to help set the person’s expectations regarding the psychedelic experience, while integration sessions are designed to thoroughly review and consolidate the participant’s experience during the dosing session.

Blood samples will be withdrawn before dosing, one day after each dose, and 30 days later to assess the psychedelic’s effect on inflammation.

Silo also is developing a time-released topical delivery system to help minimize the hallucinogenic effects of psychedelic therapeutics, and testing the use of liposomal homing peptides to deliver psilocybin to target tissues.

Homing peptides are tissue-specific small molecular tags that can be integrated at the surface of small vesicles called liposomes to deliver their cargo, such as psilocybin, to targeted tissues.

“The targeted patient populations from the study could provide support for the development and use of psilocybin as a therapeutic coupled with our novel homing peptides and topical technology,” Weisblum said.