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Mydecine Innovations Group has received approval from Health Canada to supply cGMP psilocybin and MDMA to healthcare providers under the Special Access Program. This license allows practitioners to request these substances for patients with serious conditions who have not responded to conventional treatments. The company partnered with Applied Pharmaceutical Innovation to establish a manufacturing facility in Edmonton, enhancing its R&D capabilities. Mydecine also launched a Special Access Support and Supply Program to ensure safe therapy outcomes for patients in Canada.
Mydecine Innovations Group has appointed Dr. Victoria Hale to its Board of Directors, enhancing its leadership in the mental health and psychedelic therapy sectors. Dr. Hale brings extensive experience from her role as Chair of MAPS and a solid background in drug development, having raised $230 million for health initiatives. She aims to address the global mental health crisis through innovative therapeutic solutions. The appointment is seen as a strategic move for the company's future growth and underscores its commitment to improving public health outcomes.
Mydecine Innovations Group (NEO: MYCO) has submitted a pre-Investigational New Drug (IND) briefing package to the FDA for MYCO-001, aimed at smoking cessation therapy. This clinical study, led by Dr. Matthew Johnson of Johns Hopkins University, will evaluate the safety and efficacy of psilocybin-assisted psychotherapy in treating tobacco addiction. The Phase 2/3 trial is set to launch in Q2 2022, with a planned operationally seamless design to optimize resource use. Tobacco addiction remains largely untreated, highlighting the need for innovative therapy options amid safety concerns over existing treatments.
Mydecine Innovations Group has announced a partnership with Combat Stress and King's College London to further clinical trials involving MYCO-001, aimed at treating PTSD in veterans. This collaboration will explore the use of psilocybin in psychoactive-assisted psychotherapy for veterans suffering from severe PTSD resistant to conventional treatments. Professor Dominic Murphy will lead the study, which addresses a significant unmet need in mental health treatment. The partnership highlights Mydecine's commitment to developing novel therapies for mental health disorders, particularly among veterans.
Mydecine Innovations Group has established a partnership with The Newly Institute to advance psychedelic-assisted psychotherapy in Canada. Under the Special Access Support and Supply Program, Mydecine will supply cGMP psilocybin and MDMA to The Newly, which is opening mental health clinics across Canada. They aim to develop therapy protocols and manuals to enhance patient care. Both companies will collaborate on evidence-based treatments targeting mental health issues, with a revenue sharing model in place to support their efforts.
Mydecine Innovations Group has announced the launch of its Special Access Support and Supply Program (SASSP) in response to Health Canada's inclusion of psilocybin and MDMA in the Special Access Program. This initiative aims to equip healthcare professionals with essential resources for psychedelic-assisted therapy, targeting treatment-resistant patients. The SASSP provides a comprehensive package including cGMP-certified products, training, and support services. With an established production facility and partnerships, Mydecine is poised to enhance mental health treatments in Canada.
Mydecine Innovations Group (NEO: MYCO) (OTC: MYCOF) announced the completion of a target-based model for the serotonin receptor 5-HT2A, enhancing its AI-driven drug discovery program. This model will expedite the screening of billions of compounds, aiming to identify novel psychedelic molecules with improved binding affinity. The integration of AI and ML is expected to significantly cut costs and development time. Mydecine's focus on psilocybin and its active metabolite psilocin aims to address challenges such as shelf stability and onset variability, ultimately enhancing treatment for mental health disorders.
Mydecine Innovations Group (NEO: MYCO) (OTC: MYCOF) has engaged JBN Partners, LLC for a six-month term to enhance public and investor relations, with a total payment of USD$150,000. The company focuses on developing innovative therapeutics for mental health disorders, including PTSD and addiction, using advanced technology and drug development infrastructure. Founded in 2020, Mydecine aims to bridge gaps in mental health treatment with a commitment to responsible development and collaboration with leading experts in the field.
Mydecine Innovations Group (NEO: MYCO) announced a collaboration with Maya to co-develop a digital therapeutics platform. This partnership aims to enhance Mydecine's digital health platform, Mindleap, improving personalized treatment for mental health and addiction disorders. The new platform seeks FDA clearance for insurance reimbursement, enabling physicians to prescribe it alongside existing treatments. This innovation could position Mydecine at the forefront of digital healthcare, with the global digital therapeutics market projected to grow to $10.62 billion by 2025.
Mydecine Innovations Group (MYCOF) announced a private placement agreement for a convertible secured subordinated debenture worth C$5.5 million, expected to close on December 10, 2021. The financing aims to support ongoing R&D, clinical trials, and technology initiatives. The Company is poised to launch significant studies, including a smoking cessation trial with Johns Hopkins University, following positive interim results showing 59% abstinence at 12 months. The Debenture will bear a 10% interest rate and is convertible into common shares at $0.17 each.