VANCOUVER, British Columbia, May 31, 2023 (GLOBE NEWSWIRE) -- MindBio Therapeutics (CSE:MBIO) (FSE:WF6), a Melbourne, Australia-based leader in microdosing psychedelic medicines, received its initial microdoses of LSD. MindBio announced that its initial delivery of 1,000,000 microdoses of LSD had arrived at its labs, following a secure chain of custody, for process in preparation for two separate Phase 2 take home LSD-Microdosing Clinical Trials, which are both fully funded. This LSD will be used to create a novel sublingual formulation for LSD microdosing.
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All pharmaceutical medicines need to be made to the standard of Good Manufacturing Practices (GMP) which require manufacturers to ensure that their products are traceable, safe, pure and effective for human consumption.
MindBio's CEO Justin Hanka recently visited the company’s Canadian manufacturer, which is fully licensed by the Canadian Government to manufacture GMP grade LSD for the pharmaceutical industry.
The company recently announced that ethics approval has been received for a world’s first Phase 2a take home LSD-Microdosing clinical trial in patients with Major Depressive Disorder, along with approval by the Clinical Trials Registry. In this open-label trial in 20 patients with major depressive disorder, the tolerability and feasibility of an 8 week regimen of LSD-Microdosing will be tested. The results will inform a continuation trial, a much larger Phase 2b randomized triple-dummy active placebo controlled trial.
In 2022, MindBio’s Phase 1 take-home LSD-Microsdosing clinical trial, 80 healthy male volunteers were randomised into an LSD group and a Placebo group, receiving 14 doses every 3 days for 6 weeks, with the first doses given in a supervised laboratory setting, and the other doses self-administered at home. The advantage of microdosing LSD as opposed to macrodosing is that patients can take the drug and then get on with their day in much the same way they would when taking anti-depressant medication. Notably, there were no serious adverse events recorded and participants on dose days had substantial improvements in mood including increases in energy, social connectivity, creativity, wellness and happiness.
Justin Hanka, CEO and Co-founder, stated: "By using microdosing, we are creating a unique treatment model that is globally scalable, accessible, and affordable, aiming to address the existing challenges in mental health care. MindBio is amassing the world's largest repository of biometric, physiological and psychometric data from Microdosing randomised controlled clinical trials in a big data play for the Company. We are leading the world in LSD-Microdosing and look forward to providing the next exciting update from new discoveries to shareholders soon."
According to the National Alliance on Mental Illness, 300 million people worldwide experience depression. In the United States alone, 3.1 million people between the age of 12 and 17 have experienced at least one major depressive episode in the past year, with suicide the second leading cause of death among people aged 10 to 34.
The shares, which recently began trading on the Canadian Securities Exchange, are trading at $0.10. For more information, please visit the company’s website www.MindBioTherapeutics.com, contact Justin Hanka, CEO, at 61 4331 40886 or by email at justin@MindBioTherapeutics.com.
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