Mydecine Innovations Group (NEO:MYCO) (OTCMKTS:MYCOF) (FRA:0NFA) has selected substance use disorder and smoking cessation as the initial target indications for its proprietary psychedelic molecule MYCO-004.
MYCO-004 is a patch-delivered tryptamine compound and its properties include short duration (less than two hours), transdermal, precision dosing, and long-term compound stability.
Mydecine said it picked substance use disorder and smoking cessation for MYCO-004 as it addresses the underserved and drastic need for treatment.
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The company noted that there are 19.7 million American adults suffering from substance abuse disorder. Of those, 8.5 million suffer from both substance abuse disorder and mental health disorders.
Specific to nicotine addiction, the company said there is a current lack of efficiency and safety in the current nicotine treatments. Tobacco, and its active ingredient nicotine, is one of the most highly addictive substances in the world and one of the deadliest.
Mydecine said its MYCO-001, pure psilocybin from natural fungal sources, is in planning for late-stage clinical trials to treat smoking cessation, ensuring the quickest time course to regulatory approval.
MYCO-001’s analogous molecules have shown significantly higher efficacy rates in treating smoking cessation in well-known studies conducted by Johns Hopkins University while also showing significantly better safety profiles, the company added.
"We have taken a methodical and iterative staged approach in our drug development pipeline developing first and second-generation treatments to address some of society's largest unmet needs,” said Mydecine CEO Josh Bartch in a statement. “MYCO-001 is our first iteration of a generation one drug for both smoking cessation and PTSD, which is currently in a late-stage clinical trial and we believe will be one of the first psychedelic treatments to receive approvals from the FDA.”
Bartch added: “Generation one analogous MYCO-001 pure psilocybin, in which MYCO-004 was base templated from, has shown efficacy rates as high as 85% in a study conducted out of Johns Hopkins University. MYCO-004 represents a second-generation improvement to replace the first generation of drugs with improved half-life control, uptake time, scalability and stability.”
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