Toronto’s Cybin Inc. (NYSE American: CYBN) (NEO: CYBN) will soon get the final results of its psilocybin analogue clinical trial for treating major depression.
The company announced that it finished dosing the last round of participants on Wednesday and said it is close to determining the optimal dose of the CYB003 analogue, an investigational molecule with rapid onset and a shorter duration than regular psilocybin. Cybin expects to have conclusive efficacy data on the drug during this quarter and Q4.
This is the sixth group/cohort of people the company has dosed with CYB003 and Cybin has been gradually increasing the dose with each group, beginning with 1 milligram of the analogue and escalating to 12 milligrams.
The company has not reported any serious undesirable effects or adverse events among recipients of the drug and says mild to moderate issues encountered by participants during the CYB003 studies were resolved without the need for clinical intervention.
Cybin reported interim results from the CYB003 dosing studies in February and found that participants who took 8-10 milligrams of the drug had meaningful, robust and “mystical” experiences from it. The drug was found to have a rapid and short-acting psychedelic effect among those who took it.
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Cybin’s CEO Doug Drysdale says the company is currently preparing data to present to the United States Food and Drug Administration for pivotal/Phase III studies. Cybin received a Schedule I license from the U.S. Drug Enforcement Administration for in-human studies on CYB003 in August last year and dosed the first participants later that month.
“As we begin the final dose escalation cohort in our Phase 2 study, we are moving closer than ever towards our goal of determining an optimal dose for CYB003 and assessing its potential as a safe and effective therapeutic for people in need of improved treatment options for MDD,” said Drysdale.
The company says the psilocybin drug has the potential to treat alcohol use disorder as well and Cybin is also currently developing a deuterated DMT drug (CYB004) administered through an IV for the treatment of anxiety disorders.
Cybin updated its EMBARK Training Program in mid-July to enhance its ability to improve training for future pivotal studies of CYB003 and CYB004. At the end of July, the company partnered with the contract research organization Worldwide Clinical Trials to help with ongoing development of CYB003.
Cybin shares rose by 3.45 per cent Thursday to US$0.30 on the NYSE American stock exchange but have dropped by over 30 per cent in the past six months.
rowan@mugglehead.com
