Psychedelic Trials Update: Treating Meth Addiction, Fibromyalgia & General Anxiety Disorder

Three companies have provided updates on their efforts to assess different psychedelics for treating a widely varied set of conditions.

Filament To Begin Phase 2 Study On Botanical Psilocybin Drug For Meth Use Disorder

Clinical-stage natural psychedelic drug developer Filament Health Corp. FLHLF received FDA approval to conduct a Phase 2 clinical trial on the safety, tolerability and feasibility of using PEX010, the company’s botanical psilocybin drug candidate on individuals with Methamphetamine Use Disorder (MAUD.)

See also: Major Psychedelics Firm Is Studying Magic Mushrooms To Treat Meth Addiction

The investigator-initiated trial will take place at UCSF’s Translational Psychedelic Research Program (TrPR) and will assess the psychedelic therapy building on the fact that psilocybin has been shown to increase abstinence and reduce consumption in people with substance use disorders.

Co-founder and CEO Benjamin Lightburn said the company is "pleased to support this much-needed research” and added that this trial is the first to study naturally derived, non-synthetic psilocybin for MAUD.

See also: EXCLUSIVE: The Psychedelics Debate Is 'Raging' As Filament Debuts Ayahuasca Pill

Silo Pharma Announces Positive Results From IND-Enabling Study Of Novel Ketamine Formulation For Treating Fibromyalgia

Developmental-stage biopharma company Silo Pharma Inc. SILO shared positive results for its study of SP-26 - its novel time-released, dosage-controlled formulation of ketamine. 

In collaboration with Frontage Laboratories company Experimur, Silo Pharma tested SP-26 in a toxicology and tolerability study in mini pigs with an ascending dosing regimen. Using the bioanalytical methods required by the FDA, Silo expects to commence clinical studies soon.

CEO Eric Weisblum said, “We are advancing our work with our regulatory partners to prepare a Pre-Investigational New Drug (IND) package for SP-26 and intend to pursue the FDA’s streamlined 505(b)(2) regulatory pathway for drug approval.”

Incannex Health’s Phase 2 Psilocybin Trial For GAD Shows Good Results In Interim Data Analysis, No Safety Issues 

Australia-based cannabidiol and psychedelics giant Incannex Healthcare Ltd. IXHL announced positive results of an interim review of conduct, safety and data from its ongoing Phase 2 clinical trial on proprietary psilocybin-assisted psychotherapy for Generalized Anxiety Disorder (GAD).

Led by Dr. Paul Liknaitzky, head of clinical psychedelic research at Monash University, the trial is triple-blind, active placebo-controlled and involves two administrations of psilocybin in conjunction with psychotherapy during a 10-week course treatment alongside the development of a specialized therapist training program. 

Assuming the effect size observed in the 29 patients is representative of the remaining 43, results to date reveal an over 80% probability of a statistically significant benefit of psilocybin therapy measured 11 weeks post-dose. Also, no safety concerns have been identified to date.

Treatment of all 72 trial participants is anticipated to be completed in the fourth quarter of 2023. 

“I believe Incannex is leading the way in research on novel treatments for this debilitating indication,” CEO Joel Latham says. “Even though the results must remain blinded until the conclusion of the trial, the confidential review has given us the confidence to commence manufacture of our own psilocybin drug product with the appointment of Catalent, progress planning of our pivotal trials and commence drafting our FDA IND application for the PsiGAD treatment program.” 

Photo: Benzinga edit with photo by Olia Danilevich on Pexels.