Three companies have provided updates on their efforts to assess different psychedelics for treating a wide variety of conditions.
Filament To Begin Phase 2 Study On Botanical Psilocybin Drug For Meth Use Disorder
The FDA approved FLHLF, a clinical trial to conduct a Phase 2 clinical trial on the safety, tolerability and feasibility of using PEX 010, 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 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.
The company is pleased to support this much-needed research and said that this trial is the first to study 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-Enabled Study Of Novel Ketamine Formulation For Treating Fibromyalgia
SILO, a developmental-stage biopharma company, shared positive results for its study of SP 26 -- its novel time-released, dosage-controlled formulation of ketamine.
Silo Pharma tested SP 26 in a toxicology and tolerability study in mini pigs with an ascending dosing regimen in collaboration with Frontage Laboratories company Experimur. Silo expects to begin clinical studies soon, using the bioanalytic methods required by the FDA.
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 follow 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
The trial, which includes two administrations of psilocybin-assisted psychotherapy for generalized anxiety disorder GAD, was led by 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 trial on proprietary psilocybin-assisted psychotherapy for Generalized Anxiety Disorder GAD Led by Dr. Paul Liknaitzky
The effect size observed in the 29 patients is representative of the remaining 43, the results to date show an over 80% probability of a statistically significant benefit of psilocybin therapy at 11 weeks post-dose. No safety concerns have been identified to date.
The treatment of all 72 trial participants is expected to be completed in the fourth quarter of 2023.
Joel Latham, CEO, says that Incannex is leading the way in research on novel treatments for this debilitating indication. The confidential review has given us confidence to begin production of our own psilocybin drug product with the appointment of Catalent, progress planning of our pivotal trials and the drafting of our FDA IND application for the PsiGAD treatment program, even though the results must remain blinded until the end of the trial.