This week in psychedelic business news: two patents may revolutionize the medical application of psychedelic compounds; DMT and ibogaine clinical trials show promise; and stock news for psychedelic investors.
Psycheceutical, Inc., a biotechnology company developing psychedelic medicines, announced its exclusive license of two major patents that will significantly advance the medical application of psychedelic compounds.
Psycheceutical’s patented delivery systems, the Janus particle solution and the NeuroDirect™ delivery system, allow psilocybin, ibogaine, and ketamine to be administered without unwanted side effects and toxicity by bypassing the stomach and the liver.
Janus particle technology uses layered nanoparticles to target specific cells and deliver multiple medicines at different times and rates. NeuroDirect administers neuroactive compounds directly to nerve connections to the brain, bypassing the blood-brain-barrier. The latter delivery system allows for smaller doses, improved efficacy of the active compound, and immediate response in minutes, while also eliminating the potentially toxic and hallucinogenic effects of psychedelic compounds, facilitating wider medical adoption and use.
“The Janus particle technology has immense potential to transform the delivery of psychedelic therapies amid today’s mental health crisis,” says the company's Chief Science Officer Dr. Anish Tuteja. “Nearly all forms of research being done on psychedelics are via the digestive tract, which slows uptake, requires higher dosage, and may lead to harmful side effects in the body. By leveraging nanoparticle encapsulation, Psycheceutical will overcome these limitations. Psyhceceutical aims to provide similar nanoparticle-based solutions to any and all companies doing psychedelic drug development research.”
Dr. Aung Din, who developed NeuroDirect, adds, “The ability to avoid the systemic side effects of psychedelic compounds, such as nausea, dizziness, and disorientation, opens up a whole new world to neuro-therapeutics.”
Both Mindset Pharma Inc. (CSE: MSET) (FSE: 9DF) (OTCQB: MSSTF) and Psyched Wellness (CSE: PSYC) (OTCQB: PSYCF) (FSE: 5U9) announced inclusion in the AdvisorShares Psychedelics ETF traded on the NYSE Arca under the ticker symbol “PSIL.”
PSIL is an actively managed exchange-traded product that invests in the emerging psychedelic drugs sector. The PSIL offers exposure to biotechnology, pharmaceutical and life sciences companies deriving the majority of their net revenue or devoting the majority of their assets to psychedelic drugs, and only holds companies that they see as leading the way in this industry.
“We are thrilled to be considered a leader in the space and appreciate the support from the capital markets as we progress our differentiated pipeline of next generation psychedelic-inspired drug candidates towards the clinic,” says James Lanthier, Chief Executive Officer of Mindset.
Jeffrey Stevens, CEO of Psyched, says, “Psyched's inclusion in the AdvisorShares Psychedelics Exchange Traded Fund acknowledges the important research and product development the company is doing on its proprietary extract of Amanita Muscaria, AME-1. We believe AME-1 has the power to help people achieve stress relief, relaxation and restful sleep. We are grateful that the ongoing work at Psyched has been recognized by AdvisorShares and we are among the leaders in the psychedelics industry.”
Small Pharma Inc. (TSXV: DMT), a neuropharmaceutical company focused on psychedelic-assisted therapies, announced both the successful completion of the Phase I part of the combined Phase I/IIa clinical trial and the initiation of the Phase IIa part in combination with psychotherapy of its lead DMT-assisted therapy candidate, SPL026, for the treatment of Major Depressive Disorder (MDD).
Peter Rands, CEO of Small Pharma, says, “We are delighted to have made such swift and excellent progress in the seven months since starting Phase I. The successful completion of Phase I means we can now truly assess SPL026 as a new potential treatment option for patients with MDD. There has been little innovation for patients suffering from MDD in the last few decades and SPL026 has the potential to change the mental health treatment landscape and provide a much-needed alternative therapy for patients.”
DemeRx IB, Inc., an Atai Life Sciences company (Nasdaq: ATAI) focused on developing ibogaine for the treatment of opioid use disorder (OUD), announced that the first subjects have been dosed in a Phase 1/2a clinical trial of DMX-1002, its oral formulation of ibogaine.
In previously published non-controlled studies, ibogaine has demonstrated rapid and sustained efficacy in treating OUD and has the potential to be a disease modifying treatment for this vulnerable patient population seeking to end their intractable cycle of drug dependence.
The Phase 1/2a trial is designed to assess safety, tolerability, pharmacokinetics, and efficacy, and the results will inform future studies in patients with opioid use disorder.
“By launching the Phase1/2a trial, we look forward to bringing important data from carefully designed, controlled studies to the existing literature on ibogaine, a compound with substantial history,” said Dr. Deborah Mash, CEO and President of DemeRx. “We are hopeful that this early trial can begin to establish a safe and efficacious profile for Ibogaine, so that we can potentially offer a new option for patients seeking to break free from OUD who have far too few options.”
Eversio Wellness Ltd., a mushroom wellness company, announced it has harvested its first legal flush of psilocybin producing mushrooms under its Health Canada-issued Controlled Substances Dealer’s License.
In July, Eversio received its Health Canada regulatory approval to produce psilocybin for research and development, including supplying products to clinical and research trials, and to supply prescription-controlled substances to patients in need through partnerships with health care providers using Health Canada’s Special Access Program.
“Our mission is to improve lives by producing safe, standardized, natural psilocybin-based products that hold the potential to reduce suffering in many ways,” said Craig Garden, Eversio’s CEO. “Our first harvest marks a significant chapter in our company’s story as we are one step closer to bringing psychedelic mushrooms to research and healthcare communities across Canada and through global partnerships.”