DMT Archives - Green Market Report

Adam JacksonOctober 24, 2022
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4min12371

Canadian clinical stage drug development company, Algernon Pharmaceuticals Inc. (CSE: AGN) (OTCQB: AGNPF), has entered a clinical trial agreement with Yale University to study DMT for the treatment of depression.

Algernon will provide DMT for the study in return for intellectual property rights with Yale around the clinical use of the drug. The company will also have the option to negotiate licenses to both IP developed jointly and IP developed solely by Yale — subject to rights reserved by the US government in conjunction with publicly funded research.

“The study may enhance our current understanding of the dosing regimen in the subjective effects induced by DMT,” said Deepak D’souza, the trial’s principal investigator and professor of psychiatry and director of Schizophrenia Neuropharmacology Research Group at the Yale University School of Medicine.

D’Souza is an experienced researcher with DMT and other controlled substances.

Algernon will also receive data from the study that it could use for its DMT stroke research program.

“After careful consideration, we chose to support Dr. D’Souza’s clinical DMT study and work with Yale University,” said Christopher Moreau, CEO of Algernon Pharmaceuticals. “Although the treatment of psychiatric disorders with DMT is not the company’s current focus, we have patents pending on novel forms of DMT which could potentially be used across a broad range of diseases. In addition, we believe the data generated from this study may help inform Algernon’s stroke research program.”

“A rising tide lifts all boats, and we feel a corporate responsibility as well to improve global awareness and support psychedelic medicine research when possible. It is in that spirit that we also chose to become the lead sponsor of Wonderland, the world’s largest conference on psychedelic medicine to be held November 3-5 in Miami.”

N, N-Dimethyltryptamine, or DMT, is a hallucinogenic tryptamine drug producing effects similar to those of other psychedelics like LSD and psilocybin. DMT occurs naturally in many plant species and animals including humans and has been used in religious ceremonies as traditional spiritual medicine by indigenous people in the Amazon. DMT can also be synthesized in a laboratory.

The “double-blind, placebo-controlled, crossover-controlled” study will compare different bolus and constant infusion dosing regimens of DMT in healthy control participants and individuals with depression.

Algernon has active research programs for idiopathic pulmonary fibrosis (IPF) with chronic cough, chronic kidney disease and a psychedelic program investigating a proprietary form of DMT for stroke.


Debra BorchardtAugust 23, 2022
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5min1840

GH Research PLC (Nasdaq: GHRS) reported financial results for the second quarter ended June 30, 2022 and gave updates on its business. The company has no revenue at this time and is focused on developing its DMT drugs for mental health issues. The company also said it does not expect to have revenue for several years. GH Research has $265.4 million in cash as of June 30, 2022, compared to $276.8 million as of December 31, 2021. The company said it believes that has enough capital to fund its operating expenses and capital expenditure requirements into 2025.

GH Research reported a net profit of $0.3 million, or $0.006 earnings per share, for the quarter versus a net loss of $2.1 million, or $0.053 loss per share, for the same quarter in 2021. This was due to the foreign exchange gain in the quarter.

In May 2022, the company announced the positive outcome of its pre-IND meeting with the U.S. Food and Drug Administration (FDA) and said it expects to submit the IND for GH001 in TRD no later than the first quarter of 2023. GH001 is the proprietary inhalable 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) product candidate. The planned IND-opening study is a Phase 1 imaging study in patients with TRD designed to further elucidate the mechanism of action of GH001 (GH001-TRD-104).

Expenses

R&D expenses were $4.2 million for the quarter versus $2.0 million for the same quarter in 2021. The increase was primarily due to increased activities relating to the company’s technical development and clinical trials and increases in employee expenses to support these activities. G&A expenses were $2.5 million for the quarter versus $0.7 million for the same quarter in 2021. The increase was primarily due to an increase in insurance costs, as well as increased employee expenses.

Studies

In March 2022, GH Research announced its plan to submit clinical trial applications in several European countries for a multi-center, randomized, controlled Phase 2b trial of GH001 in treatment-resistant depression (TRD) (GH001-TRD-201). “We plan to submit such applications beginning in the third quarter of 2022. When such applications are approved, we expect to recruit approximately 80 patients for this trial. The primary objective will be to determine the efficacy of a single-day individualized-dosing regimen (IDR) of GH001 compared with placebo in improving depressive symptoms as assessed by the mean change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) at the end of the 7-day double-blind phase.”
In May 2022, the company announced the positive outcome of its pre-IND meeting with the U.S. Food and Drug Administration (FDA), and expects to submit the IND for GH001 in TRD not later than the first quarter of 2023. The planned IND-opening study is a Phase 1 imaging study in patients with TRD designed to further elucidate the mechanism of action of GH001 (GH001-TRD-104).
“Our recently announced Phase 2a proof-of-concept clinical trials of GH001 for the treatment of patients with bipolar II disorder and a current depressive episode (BDII) (GH001-BD-202) and for the treatment of patients with postpartum depression (PPD) (GH001-PPD-203) have now received regulatory approvals and site startup activities have commenced. The trials have an open-label, single-arm design with 7 days duration and they are expected to recruit approximately 15 patients each. The primary objective of the trials will be to determine the efficacy of a single day IDR of GH001 in improving depressive symptoms as assessed by mean change in MADRS from baseline to day 7.”

 

 


Dave HodesMay 4, 2022
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6min1420

Small Pharma (OTC: DMTTF), a London-based neuropharmaceutical company focused on psychedelic-assisted therapies, made big news recently with the announcement of the first clinical trial in February 2021, using N, N-Dimethyltryptamine (DMT) to treat major depressive disorder. “We’re doing it in combination with psychotherapy, because we have reasons to believe that what psychedelics really do is enhance the potential for psychotherapy to improve the condition,” Small Pharma CEO Peter Rands told Psychedealia

“We conducted a phase 1 clinical study in 2021, completed in September, that assessed four different dose levels of DMT in 32 psychedelic naïve volunteer subjects because the majority of major depression sufferers will be psychedelics naïve,” Rands said.

DMT is a very short and intense experience and is given by interjection, that lasts about 20 minutes. “What we’re trying to demonstrate with the patient study, and where we’ve taken the sort of optimal base, is to give a fully psychedelic experience to everyone that participated,” he said. “They would have a full psychedelic experience and a very good tolerability, which was largely what we’re trying to assess in psychedelic subjects, as well as DMT being their first psychedelic experience.”

They are in the next phase of the clinical study, initiating the blinded, randomized, placebo-controlled, proof-of-concept Phase IIa study in 42 patients with major depressive disorder. 

That study is being held at two UK clinical trial sites—Hammersmith Medicines Research and MAC Clinical Research—and has been modeled on an ayahuasca case study, Rands said. DMT is often associated with ayahuasca because it is the brew’s main psychoactive ingredient. 

Results are anticipated sometime this year. “The critical difference is that ayahuasca creates a long-lasting psychedelic experience, which is made orally available,” he said, noting that DMT is not normally orally active, but it can be drunk. “If we’re successful, then we will take this to phase 2b, and we will progress our pipeline,” Rands said. 

Small Pharma began in 2015 when Rands and his team were looking for viable projects they could initiate based on known active ingredients with some sort of proprietary and innovative profile. “That took us to mental health, and specifically the role of ketamine in treating depression,” Rands said. “We discovered reading in the literature that there was very promising preclinical data supporting a rapid-acting antidepressant quality of one of the ketamine metabolites. It didn’t have the same abuse potential that ketamine has, which at the time was a big question about the commercial viability of ketamine as a treatment.”

He said that they started with that project, but two years later, with the data coming out about psychedelics, they switched focus. “We thought what would really change patients’ outcomes will be the psychedelic space not the sort of non-psychedelic headspace, as it were.” 

Why the name Small Pharma? Rands wrote on the company website that they called themselves Small Pharma because they “knew more what we weren’t than what we were. We weren’t deep-pocketed or well known, which meant we were unencumbered by legacy pipelines or mismanaged expectations.

He explained further: “We are focused at the stage of development where Big Pharma typically struggles to innovate these days,” he said. “We don’t consider ourselves different, fundamentally, from Big Pharma. It’s all the same people who work in these companies,” Rands said. “What does separate us is the mission. So we can and should work on higher risk programs, that if they succeed, we’ll have a very strong value increase up until the stage where it can be passed on to big pharma company.”

Rands said that while Small Pharma hasn’t partnered with any big pharma companies yet because they feel that there is more clinical work they can do before entering a deal. But that it’s “always been on our radar.”


Dave HodesFebruary 24, 2022
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9min2170

The psychedelic world was caught by surprise when boxer Mike Tyson admitted using DMT (5-MeO-DMT) on a dare for the first time in 2017—a powerful psychedelic derived from the venom of the Sonoran Desert toad (and other plant species). Tyson was looking for help with problems in his life at the time. He claims DMT changed everything for the better. 

He has now tripped on this strong version of DMT over 53 times, and reportedly has a nursery of Sonoran Desert toads at his ranch in Desert Hot Springs, California.

What Tyson is taking is DMT that 4 to 6 times stronger and more intense than the other plant-based version, N,N Dimethyltryptamine, which is the active ingredient of the psychoactive drink, ayahuasca. There is also a DMT derivative found in certain marine sponges.

People who experience DMT talk about entering “hyperspace” in a private “ritual-like” personal experience. It is known to produce out-of-body states and profound changes in sensory perception.

It works fast—if smoked or injected, DMT peaks within a few minutes, and is over within an hour.

Lab research is limited, but the first field study of DMT was done in late 2021 with experienced DMT users observed during their non-clinical use of the DMT at home, and later interviewed after their experience. They reported profound and highly intense experiences, including encounters with other beings, and experiences of going into other worlds.

Those intense experiences from DMT—some reportedly akin to alien abduction and near death—are part of the reason that DMT has, until recently, been low on the list of psychedelics researchers. They are trying to figure out the best way to use it for human health conditions, generally working with small groups of people who are experienced using DMT. But as the Tyson story demonstrates, DMT curiosity among the general public is growing. Researchers today are finding more first-time users signing up for studies.

The first human experience with pure DMT was in April 1956, when Hungarian chemist and psychiatrist Stephen Szara self-administered it intramuscularly and reported sensations such as “brilliantly colored oriental motifs and wonderful scenes altering rapidly.”

There have been just a few other studies since the mid-1990s concentrating on the hyperspace effect, and descriptions of the alien entity encounters and descriptions. 

But the pace of studies is quickly changing. 

Researchers believe that something significant can be done with a substance where people who use it experience “breaking through” to other immersive worlds that are hyper-vivid, intricate and impossible, as well as interacting with other beings such as aliens, fairies, or even clowns. 

It is believed that the DMT experience can help increase a person’s worldview, decrease death anxiety, aid the personal connection with oneself—all of which are the positive basic goals of psychedelic research using other substances.

Other studies find that DMT naturally occurs in mammals, and may be made and secreted in the human pineal gland.

There is an expanding list of uses of both N,N-Dimethyltryptamine and 5-MeO-DMT that go beyond mental health issues—from recovering motor and sensory function after a spinal cord injury, to preventing tooth loss, to treating food allergies and even as a “novel rodent control agent” in a study by the National Institutes of Health and Harvard College.

Yale University is studying DMT to treat headaches; Applied Biology Inc., headquartered in Irvine, California, a biotechnology company specializing in hair science, is studying DMT as a topical agent to treat hair loss; Rejoy, also based in Irvine, California, is studying DMT for a topical application treating female sexual dysfunction.

Researchers are intrigued by the stronger version of DMT because it works much faster than psilocybin, making it easier to use as a method to treat depression and anxiety, according to Alan Davis, an adjunct assistant professor in the Psychedelic Research Unit at Johns Hopkins University. “Because 5-MeO-DMT is short-acting and lasts approximately 30-90 minutes, it could be much easier to use as an adjunct to therapy because current therapies usually involve a 60–90-minute session,” Davis said.

Researchers always caution using DMT recreationally or in any uncontrolled setting because of its strong and overpowering effect. But DMT apparently has found its way into the psychedelics underground, with nicknames such as Dimitri, fantasia, businessmen’s trip, businessmen’s special, 45-minute psychosis floating around.

There is still much to find out about DMT, according to a 2018 study about its role and function as a therapeutic. “At present, the data arguing for the use of DMT as a therapeutic, particularly via administration, is thin,” the study stated. “There have been proposals that DMT might be useful to treat substance abuse, inflammation, or even cancer. However, at this point, the necessary data to support such proposals have not been presented and it would be premature to propose that DMT will become commonly used for clinical purposes.”


StaffOctober 28, 2021
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4min1320

Psychedelic biopharmaceutical company GH Research PLC (NASDAQ: GHRS) saw its shares pop over 15% in trading after the company was named in a hedge fund purchase. Mark Lampert’s Biotechnology Value Fund initiated $200 million worth of brand new positions in depression drug-focused GH Research, making it the largest stock holding of the fund’s 13F portfolio.

Last month, the company noted that it has $292 million in cash and the net loss was $2.1 million, or $0.053 loss per share. Its R&D expenses were $2 million for the quarter versus just $39 thousand for the same quarter in 2020. The increase was primarily due to increased activities relating to its technical developments and clinical trials and increases in employee expenses to support these activities. The stock was rising 17% at one point in trading, but was lately selling at $19.47. GH Research went public in June pricing shares at $16.

GH Research reported that its inhalable 5-Methoxy-N, N-Dimethyltryptamine (5-MeO-DMT) product candidate also called GH001, is currently being investigated in the Phase 2 part of an ongoing open-label, single-arm Phase 1/2 clinical trial in patients with Treatment-Resistant Depression (TRD). “Based on the observed clinical activity in the Phase 1 part of the trial, we believe that administration of a single dose of GH001 has the potential to induce ultra-rapid remissions as measured by the Montgomery–Åsberg Depression Rating Scale, or MADRS, in certain patients. The goal of the ongoing Phase 2 part, which we expect to complete in the fourth quarter of 2021, is to assess whether an individualized dosing regimen with intra-subject dose escalation within a single day can further increase the MADRS remission rate as compared to a single dose of GH001.”

We have previously announced the plan to conduct a clinical pharmacology trial in healthy volunteers to further elucidate the pharmacokinetic profile of GH001. This trial has been initiated and is expected to be completed in the fourth quarter of 2021.

GH Research said that once these studies are completed, it plans to request a pre-IND meeting with the FDA and a Scientific Advice meeting with the EMA and plan to initiate a multi-center, randomized, controlled Phase 2b trial in TRD. “Given GH001’s mechanism of action, we believe that GH001 may confer beneficial effects as an earlier line of treatment in MDD, including the potential to serve as a front-line treatment, as well as in other psychiatric and neurological disorders with unmet medical needs. We plan to initiate proof-of-concept Phase 2a trials in two such disorders.”

DMT

The 5-MeO-DMT is analogous to the N,N-DMT, one of the main active ingredients of Ayahuasca, a millenarian decoction used as a sacrament by South American indigenous tribes, known to induce powerful hallucinogenic states when administered. Itn addition to being found in plants, it is also secreted by the glands of at least one toad species, the Sonoran Desert toad.


StaffFebruary 25, 2021
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3min1110

PharmaDrug Inc. (CSE: BUZZ) (OTC Pink: LMLLF) has filed for an application with the U.S. Food and Drug Administration to receive Orphan Drug Designation (“ODD”) for N,N-Dimethyltryptamine or DMT in the prevention of ischemia-reperfusion injury in patients undergoing kidney transplantation.

The company explained that Ischemia/reperfusion injury (IRI) is caused by a sudden temporary impairment of the blood flow to a particular organ. PharmaDrug noted that research studies have shown that DMT activates the sigma-1 receptor (“Sig-1R”), an intracellular chaperone fulfilling an interface role between the endoplasmic reticulum and mitochondria in cells. Sig-IR ensures the correct transmission of ER stress into the nucleus resulting in the enhanced production of anti-stress and antioxidant proteins. “DMT has also been shown to have anti-inflammatory properties. Consistent with these functions, DMT was found to mitigate ischemia-reperfusion injury (IRI) caused by hypoxia, oxidative stress and inflammation in preclinical models of renal transplantation.[2] The anti-inflammatory protective effects of DMT may provide a novel, more beneficial strategy to attenuate the damage induced by ischemia and reperfusion during kidney transplantation.”

“We have been focused on laying the foundation in becoming an industry leader in the research and development of novel uses for DMT in the treatment of neuropsychiatric, neurological and inflammatory disorders,” said Daniel Cohen, CEO of PharmaDrug. “Although DMT is commonly associated with offering an intense psychedelic experience, the therapeutic potential of DMT is fascinating and remains underexplored. We aim to unlock the potential of DMT in treating unmet medical needs beyond its potential utility in mental health disorders. Our orphan drug designation application for DMT in the prevention of kidney injury during transplant surgery fits with our psychedelic pharmaceutical strategy of creating a unique portfolio of DMT therapies targeting rare disorders while also focusing on foundational research with DMT to explore and evaluate its therapeutic potential both in the brain and other human organs.”

Earlier this month, PharmaDrug filed an application with the FDA to receive Orphan Drug Designation for DMT in the treatment of acute ischemic stroke patients presenting for emergency medical assistance within 3-hours of symptom onset.


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