After his brother overdosed in 2019, Timothy Ko founded Entheon Biomedical (ENBI) on his quest to find a better treatment for addiction through psychedelic therapy.
The company is focused on advancing the DMT molecule to treat substance use disorders. It just submitted a regulatory package to an ethics committee for a human clinical trial on healthy smokers, which will be one of the most comprehensive studies of DMT ever.
Entheon has also begun recruiting patients with treatment-resistant depression for a ketamine therapy study, which will be conducted with Heading Health LLC. The study will use an electroencephalography (EEG) headset and genetic screening to:
Understand how ketamine influences brainwave patterns
Investigate how genetic markers influence ketamine response
Explore the effects of music on therapeutic outcomes
Develop a framework for characterizing the psychedelic drug state
Until now, the only way for patients to access psychedelic therapy outside a clinical trial was to apply for a Section 56 exemption and wait months on end to (possibly) receive approval from Health Canada.
Despite six more patients receiving the exemption over the holidays, the system remains flawed.
Thankfully, this Wednesday, Health Canada made an amendment to this thing called the Special Access Program (SAP), which enables healthcare practitioners to request access to drugs that are not yet approved, but have shown promise in clinical trials.
The amendment allows practitioners to request access to psilocybin and MDMA for their patients with serious, life-threatening, or treatment-adverse conditions. And the best part: requests are typically processed in just 1 day! 🎉
While this does not guarantee access for patients, it certainly feels like a big step in the right direction.
Compass Pathways’ (CMPS) early psilocybin research was published in The Journal of Psychopharmacology this week. The study suggests that both low and high doses of psilocybin are safe to administer in group settings and do not have negative impacts on thought patterns or processing of emotions.