Mydecine Innovations Group, a Denver, Colorado-based psychedelics research company, is taking an important first step in obtaining regulatory approval in the United States and Canada to develop psychedelic therapies and hold clinical trials with them. The company announced this week that it will unveil four novel drug candidates derived from natural psychedelics at Pre-Investigational New Drug meetings with the U.S. Food and Drug Administration (FDA) and Health Canada.
“Our first four novel drug candidates deliver on our long-term strategic road map for drug development with regular milestones that iteratively add value over time. By increasing the complexity of these compounds, we are increasing layers of patents applied, which in turn, also adds pharmaceutical value to the drug candidates,” Joshua Bartch, Co-Founder and CEO, Mydecine Innovations Group, in a statement.
The candidates are derived from natural psychedelics, such as psilocybin, the psychoactive chemical in magic mushrooms. By altering the molecules, Mydecine is able to obtain a patent to market the compound.
The four novel drug candidates include:
- MYCO-001: A pure psilocybin derived from natural fungal sources. It is designed to be used in mid-to-late clinical trials.
- MYCO-002: An entactogenic compound similar to MDMA with reduced harm and improved the safety profile.
- MYCO-003: A psilocybin-based formula with reduced anxiety potential. This compound is designed to remove the possibility of “bad trips” even among severely ill patients.
- MYCO-004: A patch that delivers a precise dose of tryptamine. It is designed to have a short duration of less than two hours with long-term compound stability. The patch is designed to be used in mid-to-late-stage clinical trials.
“These candidates add layers of safety and dose-ability for the use of psychedelic compounds in medical research and eventually medical practice,” said Chief Science Office and Co-Founder of Mydecine Rob Roscow. “We want to create attractive features for the research community by providing compounds that can enhance therapy, reduce anxiety, and maximize delivery mechanisms.”
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