The Pulse: Psychedelic News From Technology Networks Issue 4

Hello and welcome to the Pulse, the monthly psychedelics industry roundup from Technology Networks and Analytical Cannabis. Here, we’ll highlight some of the most significant psychedelic industry news from the past month, including important announcements, pre-clinical work and the latest from groundbreaking psychedelic clinical trials. Keep on the pulse of psychedelics and more by subscribing to our Breaking Science Newsletter below.

Highlights

Biomind Labs, a biotech focused on neurological disorders, has kickstarted a Phase II clinical trial for its candidate drug BMND08 – a sublingual formulation based on 5-MeO-DMT. Biomind is targeting anxiety and depression in Alzheimer's disease. The trial, led by neuroscientist Dr. Martín Bruno, has recruited 40 people aged 50–75. The trial, based at  Dr. Marcial Quiroga Hospital in Argentina, will look at how these psychiatric symptoms are affected by BMND08 in the context of mild cognitive impairment (MCI), which is thought to precede symptomatic Alzheimer’s. The trial will also look at whether improving anxiety and depression can delay the progression to Alzheimer’s in this patient group. Biomind’s trial will look to address the 55 million people worldwide living with dementia – a figure that is expected to rapidly increase later in the 21^st century. Alzheimer’s accounts for the majority of these cases.

Filament Health, a clinical-stage drug company focusing on natural psychedelics, has completed its first-ever Nagoya Protocol-compliant import of Tabernanthe iboga root from Gabon to its R&D facility in Vancouver. The Nagoya Protocol, signed in 2010, is a supplement agreement to the 1992 Convention on Biological Diversity (CBD). It aims to ensure fair and equitable sharing of benefits from the utilization of genetic resources.

Iboga, a shrub native to Central Africa, contains the psychoactive compound ibogaine, which has been traditionally used in the area for centuries of ceremonial practices and rituals. Filament will analyze and process the root alongside partner Terragnosis. Filament has focused on using ethically sourced and high-quality ibogaine and iboga extracts, with the ultimate aim of testing the compounds’ potential in treating substance use disorders. Ibogaine remains a relatively poorly studied natural psychedelic. The first batch of extract will be delivered to Ambio Life Sciences, a partner of Terragnosis operating retreat facilities in Mexico.

In Brief

• Beckley Psytech has dosed the first patient in its Phase IIa study for treatment-resistant depression (TRD). Beckley is testing its BPL-003 compound, a synthetic formulation of the psychedelic compound 5-MeO-DMT that is administered intranasally. Beckley expects topline results later this year. Beckley also received FDA approval for a Phase IIb study in TRD patients, with initial results expected in 2024.
• Apex Labs has received the green light from Health Canada for its phase 2b study, SUMMIT-90, which evaluates the use of a synthetic version of psilocybin, APEX-90, in combination with assisted psychotherapy for the treatment of severe depression within diagnosed PTSD. The study, which will be double-blinded and placebo-controlled, aims to recruit 160 patients. Apex also has a microdose synthetic psilocybin drug asset, APEX-52, optimized for mild-to-moderate depression, which has received permission to advance to a phase 2b study, PATHFINDER-52, which will enlist 294 patients – a size unheard of in the field.
• In the pre-clinical realm, Mydecine has shared promising results from its MYCO-006 family of drugs in mouse models. These drugs are synthetic versions of MDMA. Mydecine’s data indicates a considerably shorter half-life and accelerated onset compared to MDMA, while retaining similar therapeutic effects. The company believes that these enhanced features will improve the drugs’ utility in existing medical and clinical settings.