Mydecine December Company Update
December 16, 2021
Friends, Colleagues and Shareholders,
As 2021 comes to an end, we are excited to share these significant milestones with you.
Why We're Excited about MYCO-001 For Smoking Cessation
We have been working closely with Dr. Johnson and Johns Hopkins University to advance our lead drug candidate MYCO-001, 99% pure psilocybin, as a smoking cessation treatment.
Dr. Johnson recently reported his interim results at Microdose’s Psychedelic Medicine Business Event, from his current smoking cessation study, utilizing a single macro-dose of psilocybin. The study involved 100 treatment-resistant patients and were randomized to psilocybin or the nicotine patch, each receiving the same cognitive-behavioral therapy.
At 12 months, 59% of the patients who received the psilocybin treatment remained abstinent, while only 28% of those who received the nicotine patch remained abstinent.
We believe Dr. Johnson’s recently reported results are significantly higher than similar trials utilizing a single dose, further signaling that Mydecine’s approach to smoking cessation shows significant promise to our competitors in the space.
In addition to our previously announced Seamless Phase 2/3 Smoking Cessation Study, we also announced our plan to supply MYCO-001 for Dr. Johnson’s Multi-Site NIDA Grant-Funded Smoking Cessation Study being conducted at Johns Hopkins University (“JHU”), New York University, and the University of Alabama Birmingham.
Both studies will run concurrently and are planned to launch early next year. The safety and efficacy data collected from the NIDA grant study will support the outcome of our phase 2/3 smoking cessation clinical trial.
Successful Synthesis of Novel Tryptamine Improving the Pharmaceutical Properties of Psilocin
In late October, we announced a successful synthesis of a novel psilocin analogue with improved pharmaceutical properties further expanding our library of patent-pending tryptamines. Our ability to rapidly uncover safer and more efficacious novel compounds is a true testament to the value and success of our AI-driven drug discovery program and brings us closer to introducing the next generation of psychedelic-based therapeutics to the market.
Mydecine’s AI-driven drug discovery program is part of a joint research venture with Applied Pharmaceutical Innovation (API) at the University of Alberta. Since partnering with API in February 2021 and integrating its advanced AI technology, we have accelerated our natural product research and novel drug design, allowing us to scale faster than would be achievable with traditional research methods.
Full Patent Application Covering New Formulations That Bring Nanoemulsion Technology to Traditional Medicine Ingredients
In early November, we announced an application for a technology patent utilizing nanoemulsion technology to enhance, stabilize and make repeatable properties of ingredients from traditional medicine. These GRAS-pending nanotechnology formulations offer a significant opportunity to enhance the bioavailability of natural compounds found in traditional medicine, such as reishi and cordyceps, so that they can be added to an expanding variety of consumer products to achieve enhanced benefits.
By fine-tuning our formulations and extraction processes, we are able to deliver these valuable properties more accurately and effectively to consumers. The compatibility of these formulas as patent-protected ingredients has Mydecine excited to develop a wide variety of licensing opportunities.
Full Patent Application Covering Multiple Families of Psilocin Analogs
Earlier this week, we announced the filing of a full patent application covering multiple families of psilocin analogs. The application includes solutions to directly address further precision in delivery control and shelf stabilization of psilocin, psilocybin’s active metabolite, both of which are critical for use in the medical setting.
Our patent-pending dermal route for administration provides more control over the drug while also possibly eliminating undesirable properties like nausea by bypassing the digestive system. Additionally, this application includes a family of stabilized psilocin analogs further addressing stability concerns of psilocybin as it stands in nature.
The goal of creating these improved second-generation compounds is to enable safer, more effective treatments for patients along with improved management of dosage and drug behavior for clinicians. We believe these improvements are necessary for psychedelic medicines to become an accepted and adopted form of treatment.
Dr. Saeid Babaei Appointed Independent Board Member
Also shared this week was the appointment of Dr. Saeid Babaei, PhD, to our Board of Directors. Dr. Babaei is an experienced leader in bringing drug products from early development to commercialization. His track record includes over 20 years of academic and corporate experience, during which he has led a number of novel and first-in-class product opportunities to either commercialization or to late-stage development. The addition of Dr. Babaei moves us one step closer to meeting requirements for our anticipated listing on the NASDAQ in Q1 2022.
Mydecine Launches New Website
We have launched a new website at www.mydecine.com that’s full of investor resources like our updated investor deck, our newsroom, and the ability to sign up for automatic email alerts when we publish news. Head to the About Page to learn more about our company mission and vision.
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