January Company Update
January 31, 2022
Friends, Colleagues and Shareholders,
Mydecine has kicked off the new year with several exciting announcements. From dramatically enhancing our drug development process, to forming key partnerships, to launching new ways to bring psychedelic-assisted psychotherapy to patients, we are making great strides as we head into 2022.
Smoking Cessation Clinical Trials
We are preparing for the launch of our seamless phase 2/3 smoking cessation study to assess the safety and efficacy of MYCO-001 in treating nicotine dependence. Research will be led by Dr. Matt Johnson with our flagship study location at Johns Hopkins University (JHU). We have been working proactively with our FDA consulting team to prepare for all the requirements, and we look forward to meeting with the FDA in late February. Once we receive FDA approval, we will begin the patient recruitment process.
Additionally, Dr. Johnson is leading a multi-site NIDA grant-funded smoking cessation study this year, also utilizing our lead drug candidate MYCO-001. The study will run concurrently with our phase 2/3 study and includes sites at JHU, New York University and the University of Alabama Birmingham.
Mydecine’s Special Access Support and Supply Program in Canada
With the addition of psilocybin and MDMA to Health Canada’s Special Access Program (SAP), Mydecine plans to offer a package of cGMP products and support services promoting responsible administration to patients and creating near-term revenue potential.
Our Special Access Support and Supply Program (SASSP) will provide products and services to physicians, clinics and hospitals in Canada that want to offer psychedelic-assisted psychotherapy as a new option for patients who haven’t seen success with other treatments.
We are excited to be able to fill a critical gap in the market by providing thousands of healthcare professionals and clinics with the resources to bring these treatments to patients in need.
Mydecine Partners with The Newly Institute to Expand Patient Access to Psychedelic-Assisted Psychotherapy
We are excited to share our new partnership with The Newly Institute! The Newly Institute is a Calgary, Alberta-based company opening private, interdisciplinary mental health clinics across Canada and is Mydecine’s first partner under our recently announced SASSP.
Together, we will co-develop the protocols, therapy manuals and training that healthcare providers need to treat patients safely and effectively with psychedelic-assisted psychotherapy. Mydecine will provide cGMP psilocybin and MDMA alongside the safety and efficacy data needed to gain acceptance into Health Canada’s SAP. The Newly Institute will provide the clinic locations and experienced therapists needed to perform the treatments. We intend to enter into a revenue-sharing agreement.
Artificial Intelligence (AI) & Machine Learning (ML) Drug Discovery
We recently completed a target-based model of the classic psychedelic serotonin receptor 5-HT2A for use in our AI-driven drug discovery program. The new model will allow us to expeditiously screen billions of structures to determine which novel compounds are most likely to increase binding affinity, enabling us to continue creating improved second- and third-generation molecules for medical use.
With the ability to quickly screen billions of compounds, Mydecine’s new serotonin receptor model (5-HT2A) will allow us to rapidly increase drug analysis, promoting near-term patent filings for novel molecules. By using AI and ML, we maximize success by focusing on molecules with known medical value when creating new compounds, saving us time and money.
Mydecine and Maya to Co-Develop a Novel Prescription Digital Therapeutic Platform
We plan to co-develop a novel digital therapeutics (DTx) platform with Maya, which would allow us to enhance treatment effectiveness by pairing the DTx with our existing digital health platform, Mindleap, and creating more personalized treatments for patients.
Physicians will be able to prescribe the new digital therapeutic in addition to Mydecine’s drug and therapy protocols, or as a standalone option.
Through robust scientific research, strong collaborations and best practices, our team is working hard to advance innovative treatment options for the patients who need them. We are happy to share these recent successes and look forward to keeping you up to date on Mydecine’s progress.