If you’re just now considering the therapeutic value of psychedelics, Cybin Inc (NYSE:CYBN) is many trips ahead of you.
The Toronto-based company is studying derivatives of psilocybin and DMT and plans to file an investigational new drug application with the FDA during this quarter, CEO Doug Drysdale said Tuesday at the inaugural Benzinga Psychedelics Capital Conference.
Decades of information is available on classical psychedelics that shows both evidence of efficacy and limitations, Drysdale told Natan Ponieman, Benzinga’s head of psychedelics content.
“If you could create a drug that was faster onset; shorter in duration; more manageable; less variable; and more predictable, we think that’s worth investing in,” the CEO said of developing second-generation psychedelics.
Those qualities make a drug more likely to be covered by insurance, he said.
A More Predictable Psilocybin: For psilocybin, those limitations include its long-acting nature — six to eight hours for a treatment session — and long onset time of 90 minutes for peak effects, Drysdale told Ponieman.
“That’s a really long time to be in a clinical setting.”
Cue CYB003, a deuterated psilocybin analog and potential major depressive disorder treatment. Its onset is about twice as fast as psilocybin, with peak effects in about 30 minutes and a duration of 2 1/2 to 3 hours, the Cybin CEO said.
The company is taking CYB003 into the clinic this year and preparing an investigational new drug application. Cybin plans to begin a study of the drug in major depressive disorder in 2022 and expects a readout in early 2023.
Psilocybin is a prodrug that converts to psilocin in the body, and its metabolism “varies enormously,” Drysdale said.
“That means the response is quite unpredictable, and in a clinical setting that’s not a good thing.”
CYB003 is 80% less variable at the time of peak effect than psilocybin, with the original magic mushroom showing large data ranges and Cybin’s drug showing tight data points, he said.
The Next Generation Of DMT: A second drug being developed by Cybin, CYB004, is deuterated DMT.
The drug, when taken nasally or injected, has a rapid onset and is a short experience of 6-10 minutes, Drysdale explained.
“Patients are essentially in another realm within seconds.”
CYB004 aims to slow the breakdown of DMT, extending the effects to about 30 minutes. It’s dosed via nebulizer inhalation, which Drysdale said is highly controllable and allows for a smoother onset and flexible dosing.
Patients could be “in a clinic and out again in about an hour,” he said. Cybin is researching the drug as a treatment for anxiety.
The Rest Of Cybin’s Pipeline: CYB005, is a derivative of phenthylamine, or PEA, a drug in the same family as MDMA. The compound is in the preclinical stage of Cybin’s development pipeline.
It could have anti-inflammatory benefits at low doses, creating a possible application for neuroinflammation, such as in Parkinson’s disease, Drysdale said.
The company’s other programs are a trial of psilocybin in a group of health care workers in combination with its Embark psychedelic-assisted psychotherapy program and a study of psychedelic effects on the brain using its study partner Kernel’s neuroimaging technology.
CYBN Price Action: Cybin went public on Canada’s NEO Exchange in November 2020 and began trading on the NYSE American exchange in August 2021. The stock was trading near-flat Tuesday afternoon at 78 cents, according to Benzinga Pro.
