DMT Archives

Debra BorchardtOctober 25, 2023

Cybin Inc. (NYSE American: CYBN) (NEO: CYBN) announced that the United States Patent and Trademark Office has issued two patent grants that offer protection for its deuterated N, N-dimethyltryptamine (“DMT“) program.

“Following Cybin’s recent acquisition of Small Pharma Inc., our development programs are protected by 32 granted patents and over 170 pending applications, establishing our leadership position in developing novel tryptamine-based therapeutics in a key market. This multi-layered and robust IP protection includes composition of matter, medical use, synthesis and drug product protection, providing us with the latitude to advance our deuterated programs with confidence,” said Doug Drysdale, Cybin’s Chief Executive Officer.

The granted patents cover Cybin’s deuterated DMT program and are as follows:

United States patent no. 11,771,681, which provides a composition of matter protection for certain deuterated analogs of DMT; and

United States patent no. 11,773,062, which provides protection for medical use and the novel, efficient, and scalable synthesis of certain analogs of DMT.

Cybin said its proprietary novel deuterated DMT compounds, CYB004 and SPL028, are each currently in Phase I clinical trials. CYB004 and SPL028 target an extended DMT psychedelic experience while retaining a short-duration drug profile that could provide optimized dose formulations for different administration routes and distinct therapeutic benefits for patients. The company said that preliminary findings from the studies demonstrate that IV CYB004 and SPL028 elicit a psychedelic experience of less than 1 hour and are well-tolerated. Topline data readouts from both studies are expected in Q4 2023.

According to the National Library of Medicine, “Deuteration refers to the selective replacement of protium hydrogen isotope atoms in small-molecule drugs with deuterium hydrogen isotope atoms. Deuteration of a drug is most likely to affect pharmacokinetic properties, such as metabolism, rather than its pharmacodynamic effects. For this reason, the metabolism of certain drugs may be favorably influenced when deuterium is substituted for protium, resulting in improved safety, tolerability, or efficacy.”

In September, Cybin said it had successfully obtained a U.S. patent for the compounds it uses in pre-clinical deuterated tryptamine research. The patent, No. 11,746,088, is valid until 2041.

Adam JacksonSeptember 27, 2023

The DMT drug appeared more effective when combined with SSRIs.

Adam JacksonSeptember 8, 2023

It also includes plant-derived DMT and mescaline.

Adam JacksonAugust 23, 2023

The company expects its current cash to fund it into 2026.

Debra BorchardtJune 5, 2023

Algernon Pharmaceuticals Inc. (CSE: AGN) (OTCQB: AGNPF)announced that its subsidiary Algernon NeuroScience (AGN Neuro), has successfully completed dosing of the third and planned final cohort in its escalating dose Phase 1 clinical study of an intravenous (IV) formulation of AP-188 (DMT). AGN Neuro is the world’s first company to investigate DMT for both the treatment of stroke and traumatic brain injury (TBI).

In pre-clinical studies, DMT has been demonstrated to increase brain derived neurotropic factor (BDNF) which is believed to be a key mechanism involved in healing the brain after an injury. According to the company’s statement, DMT is believed to activate pathways involved in forming neuronal connections and has been shown to increase the number of dendritic spines on cortical neurons. Dendritic spines form synapses (connections) with other neurons and are a critical site of molecular activity in the brain.

“Neuroplasticity’s role in healing the brain after an injury is one of the most exciting areas of research going on globally in the pursuit of a treatment for stroke and TBI, and AGN Neuro is at the forefront of this work,” said Christopher J. Moreau, CEO of Algernon Pharmaceuticals. “Now that we have established the safety of a single sub psychedelic dose of DMT, we are planning to accelerate our DMT Phase 2 studies accordingly, for both stroke and TBI.”

AGN Neuro also reported that the safety review committee has confirmed that there were no safety or tolerability issues with the highest dose, which was able to maintain plasma DMT concentrations at targeted levels and which was below the established psychedelic dose. AGN Neuro is the first company to test DMT at single escalating concentrations with an IV dose for a 6-hour duration.

The single escalating dose Phase 1 trial was conducted at the Centre for Human Drug Research in Leiden, Netherlands. The purpose of the study was to identify the safety, tolerability, and pharmacokinetics of sub-psychedelic doses of DMT when administered as an intravenous bolus followed by a prolonged infusion of 6 hours, a period which has never been studied clinically. In addition, several pharmacodynamic measures believed to be associated with neuroplasticity, including both measurements of biochemical markers and electroencephalographic readings, were recorded. AGN Neuro plans to publish the data from the study in an upcoming issue of a peer reviewed, scientific publication.

Based on the success of the highest tested dose, the second part of the study, which will be scheduled to begin at a later time, will include dosing subjects for 6 hours with repeated administrations over a two-week period. AGN Neuro has now established a single dose regimen which can now be used in its first Phase 2 study for stroke and TBI.

Debra BorchardtMay 11, 2023

Psychedelic biotech company GH Research PLC (Nasdaq: GHRS) reported financial results for the first quarter that ended March 31, 2023. The company has no revenue at this time but did state that it has cash, and cash equivalents of $246.1 million down from $251.7 million at the end of 2022. The company said, “We believe that our existing cash, cash equivalents, other financial assets, and marketable securities will be sufficient for us to fund our operating expenses and capital expenditure requirements into 2026.”

GH Research reported a net loss of $10.9 million, or $0.210 loss per share, for the quarter versus $5.8 million, or $0.111 loss per share, for the same quarter in 2022.

Expenses

R&D expenses were $7.3 million for the quarter versus $4.7 million for the same quarter in 2022. The increase was primarily due to increased activities relating to our technical development and clinical trials and increases in employee expenses to support these activities. G&A expenses were $3.1 million for the quarter versus $3.3 million for the same quarter in 2022. The decrease was primarily due to lower insurance costs offset by an increase in professional costs, as well as increased employee expenses.

Drug Pipeline

The company noted that its inhalable mebufotenin (5-MeO-DMT) product candidate GH001 is currently being investigated in a multi-center, randomized, double-blind, placebo-controlled Phase 2b trial of GH001 in treatment-resistant depression (TRD) (GH001-TRD-201). “We expect to recruit approximately 80 patients for this trial across several European countries. The primary objective is to determine the efficacy of our 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,” said the company’s statement.

The company said that its randomized, double-blind, placebo-controlled, dose-ranging clinical pharmacology trial of GH002, the mebufotenin (5-MeO-DMT) product candidate formulated for administration via a proprietary intravenous approach, in healthy volunteers (GH002-HV-105) is expected to be completed in the fourth quarter of 2023.

GH Research went on to say, “We have recently filed 19 new international patent applications, which claim priority to earlier filings, further expanding our patent portfolio, which relates to various aspects of mebufotenin (5-MeO-DMT) use in a therapeutic context, including but not limited to the use of mebufotenin (5-MeO-DMT) for treatment of various disorders when administered by inhalation, or by nasal, buccal, sublingual, intravenous, intramuscular or subcutaneous routes.”

Adam JacksonMay 9, 2023

Parties exchanged legal barbs over religious freedom and the Controlled Substances Act.

Adam JacksonApril 26, 2023