The Pulse: Psychedelic News From Technology Networks

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 

Awakn Life Sciences Corp announced it has begun an investigation of a novel formula of the S-enantiomer of ketamine, esketamine, to assess its dissociative effect. This is part of Awakn’s efforts toward developing a proprietary ketamine formulation with an optimized route of administration. Awakn plans to study how its formulation affects people with harmful drinking patterns, monitoring the drug’s dissociative effects as well as its impact on alcohol cravings. The trial intends to monitor both electroencephalographic (EEG) markers and “markers of increased neuroplasticity”, Awakn states.

London-based biotech Small Pharma announced successful results from a Phase IIa clinical trial of its proprietary compound SPL026. This is an intravenous formulation of DMT that Small Pharma is developing for major depressive disorder (MDD). The study used a sample of 34 patients with moderate to severe forms of the condition. This was a two-stage trial with an initial stage that compared the effects of a single dose of SPL026 to a placebo. Both participant groups were given supportive therapy. The company reported a statistically significant reduction in symptoms linked to depression two weeks after dosing. The second open-label stage of the trial tracked the effects of a single dose of SPL026 alongside therapy for up to 12 weeks. Small Pharma reported that a “rapid and durable” effect was still observed 12 weeks post-dosing; a reduction of 15.4 on the Montgomery-Asberg Depression Rating scale (MADRS) was recorded at this point.

In Brief

• Tryp Therapeutics recently announced interim results from a Phase II trial of psilocybin for binge-eating disorder. Its compound TRP-8802, an oral dose of the magic mushroom’s compound active metabolite, psilocin, reduced daily binge eating episodes by 80% on average.
• Cybin reported results from a proof-of-principle study conducted by its partner, neurotechnology developer Kernel. The study investigated how Kernel’s Flow® device, which packs functional near-infrared spectroscopy (fNIRS) technology into a headset, was able to measure brain activity responses to ketamine. The system was able to record ketamine’s impact on physiological measures, which were associated with potential therapeutic effects.
• Apex Labs was granted approval by Health Canada to commence a large take-home psilocybin clinical trial. The Phase IIb study will explore the safety, efficacy and tolerability of a microdose of the company's proprietary oral synthetic psilocybin formulation, APEX-52. The study will recruit 294 adults experiencing depression and anxiety symptoms with a confirmed diagnosis of PTSD.
• Revive Therapeutics announced that it has entered into a research collaboration agreement with PharmaTher Holdings to evaluate the latter’s microneedle patch technology in the delivery of MDMA. The company hopes that the patch can facilitate the controlled release of the compound and enable flexible drug load capacity.
• Terran Biosciences has filed a patent for oral forms of both DMT and 5-MeO-DMT. The company suggests that the compounds can be made orally active using its proprietary prodrug approach. This approach aims to bypass extensive first-pass metabolism in the liver that makes existing DMT formulations ineffective when dosed orally.
• Seelos Therapeutics has begun a Phase I ethnobridging study in both Japanese and non-Asian volunteers to assess the safety and pharmacokinetics of SLS-002, a formulation of racemic intranasal ketamine. The company says it hopes to address the global need for therapies with antidepressant effects.