VANCOUVER, British Columbia, June 15, 2023 (GLOBE NEWSWIRE) -- MindBio Therapeutics (CSE:MBIO) (FSE:WF6), a Melbourne, Australia-based leader in microdosing psychedelic medicines, announced a significant breakthrough based on sleep data collected during randomized controlled trials of LSD-Microdosing. The trials involved 80 participants, and a total of 3,231 nights of sleep data were analyzed.
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Based on initial findings from the sleep data collected during the trials, which included the recording, measurement, and analysis of sleep patterns in both the LSD-Microdosing treatment group of 40 participants and the placebo group of 40 participants, the company confirmed positive sleep responses to its LSD-Microdosing treatment.
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, LSD-Microdosing not only improves subjective feelings related to mood, happiness, energy, creativity, social connectivity, and wellness, but it also has a statistically significant impact on sleep quality. As many as 1 in 5 adults in the USA struggle to fall asleep every single night, with half of US adults experiencing insomnia once a month or more.
Justin Hanka, CEO and Co-founder, stated: "We are delighted by the continued progress we see in the effectiveness and tolerability of MindBio's proprietary LSD-Microdosing program. The sleep data is promising for a potential tolerable alternative to sleeping pills and we are rigorously pursuing masses of data on LSD-Microdosing under randomized controlled conditions to get the evidence we need for accelerating approvals for access to this medicine for effectively treating mood and sleep disruption."
MindBio scientists are currently preparing seven upcoming research papers that analyze data from Phase 1 LSD-Microdosing trials involving 80 healthy subjects, which will serve as a foundation for the launch two fully funded Phase 2 LSD-Microdosing clinical trials in the near future.
The first trial will focus on Major Depressive Disorder, where 20 patients who meet DSM-V criteria will undergo an 8-week open-label LSD microdosing treatment regimen in a naturalistic at-home setting. This trial will serve as the basis for a larger Phase 2b trial, which will be triple-dummy and placebo-controlled, involving depressed patients.
The second trial, designed to explore the effectiveness of LSD-Microdosing in conjunction with Meaning Centred Psychotherapy for late-stage cancer patients experiencing emotional distress, will be randomized, double-blind, and placebo-controlled, with 40 participants expected to be recruited soon.
These groundbreaking findings hold particular significance in the field of depression and related mental health conditions that are of scientific interest to MindBio. For instance, conditions like pre-menstrual dysmorphic disorder are known to disproportionately affect sleep quality and have a significant impact on mental health. Commonly, a combination of antidepressants and sleeping pills is prescribed as a first-line treatment for mood and sleep disruptions. However, sleeping pills carry risks of reliance, misuse, and addiction, while antidepressants often come with unwanted side effects such as sexual impotence, weight gain, negative mood and gastrointestinal upset.
MindBio's proprietary LSD-Microdosing treatment, with its positive sleep data, presents a groundbreaking alternative to existing treatments, while further reinforcing MindBio's Big Data strategy, adding to their intellectual property and providing an effective treatment option for patients with mental health disorders.
The shares, which recently began trading on the Canadian Securities Exchange, are trading at $0.09. 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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