As more companies enter the drug development segment of the psychedelics space, we’re beginning to see overlap among research pipelines. This week, PharmaDrug announced that it has filed for FDA Orphan Drug Designation for DMT in stroke. Just last week, Algernon Pharmaceuticals announced their clinical research program for the treatment of stroke with DMT, and related provisional patent filings. The company has now signed an agreement with a laboratory for preclinical studies of DMT as part of this program. Visit our Psychedelics Drug Development Tracker to identify other points of similarity and overlap among lead candidates and indications.
It’s been a busy week in the psychedelics space, with MindMed partnering with a drug discovery startup in Switzerland, Field Trip opening its research and cultivation facility in Jamaica, Tryp Therapeutics announcing a planned Phase 2a trial, and more…
Psychedelic Sector News
MindMed Partners with Swiss Psychedelic Drug Discovery Startup, MindShift
MindMed has announced a partnership with MindShift Compounds AG, a Swiss drug discovery startup, to develop and patent next-gen psychedelic and empathogenic compounds. MindShift has already synthesized an initial tranche of such compounds, and the related patent applications have been filed by MindMed.
MindMed hopes to begin Phase 1 clinical trials in relation to these compounds by Q1 2022, via its existing clinical trials platform in Switzerland. All IP pertaining to these next-gen psychedelic and empathogenic compounds will be exclusively provided to MindMed by MindShift.
These compounds are “typically derivatives or analogues of known substances with psychedelic properties,” according to MindShift CEO, Dr. Felix Lustenberger. These include phenethylamines, tryptamines, and ergolines.
Dr. Lustenberger went on to explain, “these novel chemical structures, for example MDMA and LSD-like compounds, are designed and synthesized with expected ameliorated psychoactive properties and duration-of-effect profiles with potential added therapeutic benefits.”
The motive behind exploring such compounds lies in the potential for next-generation psychedelic derivatives and new chemical entities (NCEs) to have more predictable pharmacokinetics, with improved safety and efficacy profiles. There is a growing focus on such derivatives and analogues. A prominent example is the development of a non-hallucinogenic ibogaine analogue that appears to have a better safety profile, while maintaining its therapeutic potential (Cameron et al., 2020).
Dr. Miri Halperin Wernli, MindMed’s President and Head of Clinical Development, reflected this sentiment:
We are developing a pipeline of novel, patentable psychedelic drug candidates that are specifically engineered to improve on first generation psychedelic compounds, targeting predictable pharmacokinetics and shorter half-life that will result in better efficacy and reduced toxicity. We expect that synthesizing these next-gen psychedelic derivatives will be very useful to create predictable, pharmaceutical-grade ingredients, and will bear less regulatory risk in the overall mental healthcare system than working with natural compounds.
Psilocybin Alpha understands that MindShift Compounds AG was incorporated in September 2020. According to their Swiss Commercial Register entry, the purpose of the company is the “development of pharmacological active ingredients including advice, development, production and marketing.”
According to these filings, the sole director is Dr. Felix Lustenberger, CEO. Lustenberger is owner of LUTECO GmbH, a consultancy firm with a technology focus, and appears to have extensive experience in tech.
There is little additional information on MindShift at this point in time.
DMT for Stroke? Algernon Pharmaceuticals and PharmaDrug Target Indication
As the psychedelic drug development landscape becomes increasingly crowded, we’re keeping a keen eye on companies targeting similar indications with similar molecules and formulations. Plans to administer DMT to stroke victims, as part of Algernon Pharmaceuticals’ recently-announced program, caught the attention of mainstream media, with headlines such as:
Vancouver-based Algernon Pharmaceuticals announced the establishment of a clinical research program for the treatment of stroke with DMT last week. It hopes to be the first company to pursue DMT for stroke in humans, and plans to begin a clinical trial as early as this year. Algernon intends to use a microdose of DMT, administered via a continuous, intravenous mechanism without hallucinogenic effects. To this end, Algernon has now signed an agreement with Charles River Laboratories, which will provide preclinical studies of DMT as part of this program.
Multiple preclinical studies have demonstrated that DMT promotes neurogenesis and neuroplasticity. A study published in Experimental Neurology showed that in a rat model, DMT reduced the volume of dead cells and improved functional recovery following a cerebral ischemia-reperfusion injury (Nardai et al., 2020). Algernon hopes that these findings will be borne out in human studies.
However, PharmaDrug has now filed for FDA Orphan Drug designation for DMT in stroke. The Toronto-based company – which owns Dutch adult use retail business Super Smart – intends to use DMT for emergency medical assistance within 3 hours of stroke symptom onset.
Algernon is also intending to explore the administering of DMT “as soon as possible after the stroke injury occurs.” As such, it appears that the two companies are, at least at a broad level, targeting similar use cases. However, Algernon also has plans to explore the potential of DMT for post-stroke rehabilitation, with a focus on the drug’s potential to promote neurogenesis and structural and functional neural plasticity.
According to their press release, Algernon has filed provisional patents for new forms of DMT, as well as formulation, dosage, and method of use claims for ischemic stroke; as well as “combination therapy of DMT and Constraint Induced Movement Therapy.” It is not clear whether PharmaDrug has filed for any similar patents.
Tryp Therapeutics Plans Phase 2a Psilocybin for Eating Disorder Trial
Tryp Therapeutics is set to evaluate psilocybin in the treatment of rare and orphan over-eating disorders through a collaboration with Dr. Jennifer Miller of the University of Florida. According to Dr. Miller, there are no approved drugs and a dearth of options available for the treatment of rare over-eating disorders.
TRP-8802 is an orally-delivered formulation based on the development of the company’s synthetic psilocybin. It’s the lead candidate of Tryp’s Psilocybin-for-Neuropsychiatric Disorders (PFN) program, which the company is also hoping to apply to fibromyalgia.
Tryp also announced the appointment of Dr. Joel Castellanos as Clinical Advisor. Dr Castellanos is a respected chronic pain physician at UC San Diego Medical Center, and will work with Tryp on their psilocybin program to treat neuropathic pain. Dr Castellanos was the lead author on a 2020 review of psychedelics as a proposed mechanism of action against chronic pain (Castellanos, et al., 2020).
Numinus Completes Acquisition of Mindspace
Numinus has completed its acquisition of Mindspace, a Montreal-based wellbeing organisation that offers ketamine-assisted psychotherapy. The company currently operates two locations, with more than 1,400 clients across in-person and virtual service delivery routes.
Mindspace was one of the first providers in Canada to offer training programs for clinicians who sought to help their clients safely use psychedelics, with an emphasis on harm reduction and integration.
Field Trip Opens Jamaica Research & Cultivation Facility
Field Trip has officially opened its Research and Development Laboratory for Psychedelic Fungi, situated in Mona, Jamaica. The facility is operated via a strategic partnership with the University of West Indies. According to Field Trip, it’s “the world’s first legal research and cultivation facility dedicated exclusively to psilocybin-producing mushrooms and other plant-based psychedelics.”
CaaMTech Patent Combining Psychedelics with Cannabinoids Allowed by USPTO
CaaMTech’s first patent application, “Compositions and methods comprising a psilocybin derivative,” has been allowed by the USPTO. According to CaamTech, the patent covers, among other subject matter, “the synergistic modulatory effects of cannabinoids on the activation of serotonin receptors when administered in conjunction with a serotonin agonist.” This suggests that the co-administering of cannabinoids with tryptamines may generate beneficial effects.
The drug discovery company claims this is the “first of over one hundred patent applications” that have been filed since this first application in 2017. A notice of allowance is issued when a patent examiner deems an application to be complete, and in satisfaction of all requirements for a patent to be issued. As such, CaaMTech sees this allowance as a “watershed moment.”
Financials, Financings and IPOs
Mydecine Closes $17.25m Bought Deal Offering
Units were priced at $0.50.
Mind Cure Closes $23m Round; Lists Warrants
Mind Cure has closed a $23m bought deal offering, led by Canaccord Genuity. Units were priced at $0.60. The company also announced the issuing of 38.3m warrants, with an exercise price of $0.80 until Feb 10, 2026.
Silo Pharma Announces $4.3m Convertible Equity Financing
Silo Pharma “has entered into Securities Purchase Agreements with certain existing institutional and accredited investors for a $4.275 million fixed-price convertible preferred equity financing.”
Vogue: Could the Embrace of Psychedelics Lead to a Mental-Health Revolution?
Journalist Maya Singer takes a deep dive into psychedelics, and tries out Mindbloom’s at-home ketamine therapy. Singer also interviews Frederick Barrett, research at Johns Hopkins, who explained:
“The current model for treating problems like anxiety and depression just isn’t very good. Patients take pills every day, for years, and these medications not only have nasty side effects, they often don’t even work. But with psychedelics-assisted therapy, there’s the potential to truly alter someone’s life with just one or two sessions, because you’re getting at suffering at the source.”
Psychiatry might need some psychedelic therapy
We’re revisiting this excellent editorial by Matthew W. Johnson, published in Issue 4 of the International Review of Psychiatry, which was dedicated to the “Renaissance in Psychedelic Research.” The piece, which is open access, provides a brief history of psychedelic drugs and their re-emergence, especially in the research realm. Johnson goes on to explain that the psychedelics may provide the mechanistic (as opposed to purely descriptive) advances in psychiatry we so desperately need:
The present author holds that psychedelics may be poised to make fundamental advances in a mechanistic (both biological and psychological) understanding of psychiatric disorders.
Read the full piece here: Johnson, M. W. (2018). Psychiatry might need some psychedelic therapy. International Review of Psychiatry, 30(4), 285–290.
Stay Informed in 2021
We can only expect the rate of change and development in the psychedelic space to continue accelerating in 2021. Stay informed via our various platforms and channels…
Join our newsletter to have our Weekly Bulletin delivered to your inbox every Friday evening. We summarise the week’s most important developments and share our Weekend Reading suggestions.