Mydecine Innovations Group Inc (OTC:MYCOF, FRA:0NFA, NEO:MYCO) announced that it has partnered with Principal Investigator Dr Matthew Johnson of Johns Hopkins University on a study evaluating the administration of its lead drug candidate MYCO-001, a pure psilocybin from natural fungal sources, with a structured smoking cessation treatment program in nicotine-dependent individuals.
Dr Johnson, who has published extensively on the science of psychedelics, has been contracted by Mydecine to complete the phase 2/3 clinical trial of his ongoing research and develop methodologies to better advance future-controlled studies and clinical trials of psychedelics.
The Denver, Colorado-based biopharma focused on the treatment of mental health and addiction, said the placebo-controlled study to evaluate its proprietary psychedelic molecule MYCO-001 in treating nicotine dependence is expected to launch in the first quarter of 2022 and will look at primary endpoints of three and six months. The study could be completed by the fourth quarter of 2022.
The study will combine two or more phases into one study as an “operationally seamless clinical trial”, said the company. Therefore, it could be possible to change the study dose, treatment duration, or study endpoints. “This adaptive approach allows resources to be used more efficiently and can often be more informative and ethical than a traditional fixed design,” noted the company.
A 2014 Johns Hopkins University study published in the Journal of Psychopharmacology, showed an 80% abstinence rate at six months. Currently, the center is conducting a continuation on smoking cessation with a randomized comparative efficacy study involving 80 patients in which a transdermal nicotine patch and cognitive therapy treatment or psilocybin and cognitive therapy treatment are administered.
Over half of the patients in the ongoing study have completed their 13-week program with compelling success rates that far exceed the 10% to 35% success rates for traditional smoking cessation therapies, said the company.
In a statement, Mydecine CEO Josh Bartch said: “Current clinical data coming out of Johns Hopkins on the ongoing smoking cessation study is showing 12-month efficacy rates significantly higher than today’s gold standard with drastically increased safety profiles.”
“We have been diligently working with the teams at Hopkins, Applied Pharmaceutical Innovation, The Weinberg Group, and ethica CRO to design the planned study. We firmly believe in the high likelihood of receiving breakthrough therapy status on our MYCO-001 product for smoking cessation and look forward to updating the market soon,” he added.
According to the Centers for Disease Control and Prevention, smoking is responsible for one out of every five deaths in the US, roughly 480,000 people every year. It is also directly associated in $1.4 trillion in health expenditures and productivity losses.
Nearly 14% of the US population — 34.1 million Americans — currently smoke cigarettes. Significantly, 68% have stated they would like to quit smoking, but only around 7.5% are successful.
By 2026, the cigarette market is expected to touch $64 billion, growing at a CAGR of 16.9%. Currently, the most popular form of tobacco addiction treatment is Nicotine Replacement Therapy (NRT), with various formulations available in transdermal patches, spray, gum, lozenges.
“As a physician who has worked with patients struggling to quit highly addictive substances, I have seen first hand the tremendous harm nicotine has on the body,” said Mydecine CMO Dr Rakesh Jetly. “We are excited to be working alongside Johns Hopkins University toward safer and more effective treatments.”
Contact the author Uttara Choudhury at uttara@proactiveinvestors.com
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