The Pulse: Psychedelic News From Technology Networks Issue 5

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

Compass Pathways, a biopharma that has a good chance of offering the first approved psilocybin-based compound with its COMP360 formulation, struck a triumphant victory in the tinder-dry but vitally important area of patent law this month. Compass announced that the US Patent Trial and Appeal Board (PTAB) had reaffirmed its earlier decision to uphold two of Compass’s key patents supporting COMP360. The patents had faced a jousting content launched by patent hawk non-profit Freedom To Operate, who have challenged the patents as being overly broad and likely to stifle the distribution of psilocybin-based compounds to the public. In a blog post, FTO founder Carey Turnbull vowed to continue challenging Compass, calling their “bad patents” an example of a “negative marginal product” that subtracts, rather than adds value to the industry.

Drug developer Delix Therapeutics said that it had secured regulatory approval for its lead candidate, DLX-001, a non-hallucinogenic psychoplastogen. Delix simultaneously announced the initiation of a Phase 1 clinical trial to be conducted at the Centre for Human Drug Research in the Netherlands This trial will enroll approximately 100 healthy volunteers and focus on assessing safety, pharmacokinetics, psychometric functions, markers of brain activity and synaptic plasticity.

DLX-001 is the first of Delix’s “psychoplastogens” series of proprietary hallucinogens approved for human trials. The compound has significant therapeutic potential, says Delix, without the hallucinogenic side effects of classical psychedelics. Delix’s trial will go a long way to answering whether its vision of a take-at-home psychedelic pill can come to fruition.

Addiction therapeutics-focused biotech Awakn Life Sciences announced a strategy shift away from healthcare services to focus on research and development (R&D) of addiction therapeutics and IP licensing. Awakn will liquidate its UK clinic operations – including its pricey premises near Euston Station – and is actively searching for buyers for its Norwegian clinics. Awakn’s announcement is in keeping with industry moves away from ketamine clinic treatments, which are weighed down by significant clinical overheads in a challenging economic environment. Awakn’s focus will now be on R&D, including their AWKN-P001 program, which is looking at treatments for severe alcohol use disorder. Awakn has secured significant funding in this area from the UK Department of Health

In brief

• While 2023 has been an uncertain time for investment in the psychedelics industry, clinical biopharma Reunion Neuroscience has bucked the trend by announcing that biotechnology investment firm MPM BioImpact will acquire it in a cash transaction for around $13.1 million. Reunion’s shareholders will get a 43.1% premium on their existing share price and the deal was recommended unanimously by the board of directors. No wonder – given that Reunion was issued with a compliance letter stating it would be kicked off the NASDAQ as recently as April this year.
• Amid much hand-wringing about the best mechanism by which to infuse the body with ketamine – intravenous or intramuscular injection? – biopharma Silo Pharma, has announced a research and development agreement that bypasses the whole debate. Silo wants to study and develop a time-release ketamine implant for the treatment of fibromyalgia. The ambitious project includes testing services and small-batch pre-clinical proof-of-concept trials to determine drug release and stability. Silo is hedging its bets in this area, however, and is also developing a novel time-release topical ketamine formula.
• June also saw the 2023 edition of MAPS’ Psychedelic Science, touted as the world’s biggest psychedelic research conference. Over 10,000 people gathered to hear from researchers, policymakers, politicians from both sides of the US political aisle and Jaden Smith. While the event hasn’t been accompanied by significant business announcements or revolutionary new data, it has performed a kind of victory lap – a testament to a field that, with some effort, has dragged these once-taboo compounds into something approaching the mainstream. Whether MAPS and its CEO Rick Doblin – complete with a mushroom-messiah pearl-white suit – can make good on years of promises and deliver a fully FDA-approved psychedelic therapy will be determined in the next 12 months. It’s going to be a huge year for psychedelic science.