Algernon Pharmaceuticals (CNSX:AGN) is one of the few companies aiming to develop the classic psychedelic N,N-Dimethyltryptamine (DMT). Most recently, the company’s Algernon NeuroScience announced its plans to explore DMT as a treatment for traumatic brain injury (TBI). The company plans on launching a Phase 2 study in the fourth quarter of 2023 to test its potential in TBI. There are currently no drugs approved for the condition.
Roughly 2.5 million individuals in the U.S. sustain TBIs each year, according to the Brain Trauma Foundation.
“There are about 70 million TBIs per year globally of varying intensities,” said Christopher J. Moreau, CEO of Algernon.
Algernon consulted with TBI experts, who agreed that DMT-induced neuroplasticity was a viable target for treating the condition.
Preclinical studies have shown that DMT has promise for treating neurological disorders, including stroke and traumatic brain injury. Algernon is optimistic about DMT’s potential to spur neuroplasticity, the brain’s capacity to regenerate and form new connections. DMT could also increase brain-derived neurotrophic factor (BDNF), a protein that supports neuronal growth and repair. DMT also binds to sigma-1 receptors, which are involved in neuroprotection.
Preclinical studies in stroke piqued Algernon’s interest in DMT for TBI.
Algernon also said it had named the TBI expert Dr. Andrew Maas as a scientific and medical advisor to assist with its traumatic brain injury program. Maas is a retired professor of neurosurgery at the Antwerp University Hospital and the University of Antwerp. He is also a co-chairman of the European Brain Injury Consortium.
A Phase 1 study is underway
Early this year, Algernon launched a Phase 1 study of DMT in the Netherlands to find a safe and well-tolerated sub-psychedelic IV drug dose. The company aims to use the data from that study to explore a range of conditions. “Stroke will be one of them and now we’ve added TBI,” Moreau said.
“We’re looking at dose delivery over six-hour durations at increased frequency,” Moreau added.
Algernon announced that investigators had completed dosing the first participant group in the Phase 1 study. They found no safety or tolerability problems. Additionally, the safety review committee overseeing the investigation has given the green light to move on to the next cohort with an increased dose.
The doses in that study are sub-psychedelic. “We’re hypersensitive right now in the stroke setting to giving people a psychedelic dose,” Moreau said. Data suggest that small doses of DMT can drive neuroplasticity. In addition, Algernon is not interested in giving stroke patients a psychedelic experience. “When you’ve had a stroke, there can be a state of confusion that arises afterward, and we would like to treat patients acutely.”
Other research developments
In January, the company Small Pharma investigated using DMT to treat major depressive disorder in a Phase 2a study. The company announced that 57% of participants experienced remission at 12 weeks after receiving an intravenous dose of DMT in a Phase 2a study. The placebo-controlled study also met its primary endpoint, which related to a statistically significant and clinically relevant drop in depressive symptoms at two weeks post-dose. The study used the Montgomery-Asberg Depression Rating scale (MADRS). Participants also received supportive therapy.
Yale researcher Cyril D’Souza has explored the use of DMT for treatment-resistant depression with a single bolus injection of 0.3 mg per kg DMT and demonstrated efficacy. Neuropsychopharmacology published the data from the Phase 1 study, which involved seven subjects.
Algernon and Yale University plan on conducting a Phase 2 DMT depression study.
“You think about the power of Yale University, which reached out to Algernon for help [accessing DMT],” Moreau said. Because classic psychedelics are Schedule I compounds, they can be difficult to obtain for research. “You’ve got a lot of fear often around things that people don’t understand,” Moreau said.
Algernon has yet to see an uptick in its stock price after announcing the news Moreau said that while the company needs money to conduct research, in another way, he doesn’t care. “I know what we’re doing is important,” he said. “We’re one of a handful of companies investigating drugs to help treat stroke and TBI. And I hope that the good news will flow one day that [DMT] does make a difference and people are seeing some recovery from from this compound.”
Filed Under: Neurological Disease
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