Rapid, robust, and clinically significant reduction in depression symptoms
Trials of MB22001 show substantial improvements in mood, energy, creativity, wellbeing, depression and sleep, including REM sleep.
One month post cessation of treatment, the antidepressant response is sustained with a 65% overall reduction in depressive symptoms.
VANCOUVER, BC / ACCESSWIRE / June 20, 2024 / MindBio Therapeutics Corp. (CSE:MBIO)(Frankfurt:WF6), (the "Company" or "MindBio"), a leading biopharmaceutical company in psychiatric medicine development, is delighted to report durability data from Phase 2A clinical trials in depressed patients testing MB22001, MindBio's proprietary self-administered take home microdose of Lysergic Acid Diethylamide (LSD). We are pleased to report a significant and sustained antidepressant response in patient follow up one month post treatment.
The Phase 2a clinical trial demonstrated excellent safety, adherence and tolerance profile in doses tested. This was consistent with the Phase 1 trial results and the findings augment the mounting evidence that MB22001 is a safe and effective drug for treating depression with a psychedelic medicine to patients out in the community.
MindBio has achieved a significant milestone as the only organisation in the world that is running multiple Phase 2B clinical trials with government and regulatory approvals for take-home use and handling of a psychedelic medicine by trial patients on their own and out in the community. Patients self-administer the drug in microdoses at home, (the microdoses are sub-hallucinogenic), and patients are then able to get on with their day in the same way they would if they were taking any other medication. This is in stark contrast to the majority of later stage clinical trials in psychedelic science, where the treatment methodology is large hallucinogenic doses taken in a clinic setting usually with two therapists at the patient's side for 6-8 hours.
MindBio's thesis is that microdosing psychedelic medicines is a globally scalable, effective, affordable way to treat patients and will not have the same cost and time burden on patients that clinic based hallucinogenic treatments present. The Company currently has two Phase 2B clinical trials dosing and underway (a depression trial and a cancer trial) that have been fully funded and paid for in advance and those trials will run well into 2025.
The Company has also recently had a third Phase 2B trial in PMS (Pre-Menstrual Syndrome) and PMDD (Pre-Menstrual Dysphoric Disorder) approved for take-home dosing.
Justin Hanka, Chief Executive Officer of MindBio said, "We are delighted to discover that MB22001 has shown a sustained antidepressant response one month after cessation of treatment. This is good news for our current dosing in Phase 2B clinical trials underway and further supportive that we have developed a groundbreaking potential new treatment for depression. This data is another small step towards commercialisation".
Severity of Depression: Montgomery-Asberg Depression Rating Scale (MADRS)
We invite you to join us in support of creating a brighter future for mental health.
MindBio is a leading biotech/biopharma company focused on creating novel and emerging treatments for mental health conditions and is conducting world first take-home Microdosing (MB22001) human clinical trials. MB22001 is MindBio's lead candidate drug, a proprietary titratable form of Lysergic Acid Diethylamide (LSD) designed for take-home microdosing. MindBio is a leader in microdosing of psychedelic medicines and is advancing its drug and technology protocols through clinical trials. MindBio has developed a multi-disciplinary platform for developing treatments and is involved in psychedelic medicine development and digital therapeutics, has completed Phase 1 clinical trials in 80 healthy participants and has completed a Phase 2a clinical trial in patients with Major Depressive Disorder, both trials with positive top line data reported. Currently underway are two Phase 2B trials, one in cancer patients experiencing existential distress and another in patients with Major Depressive Disorder. The Company is also approved for multiple Phase 1/Phase 2B trials in women's health. MindBio invests in research that forms the basis for developing novel and clinically proven treatments including digital technologies and interventions to treat debilitating health conditions such as depression, anxiety and other related mental health conditions.
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