MindBio announces sustained antidepressant response 3-months post treatment in microdosing depression clinical trials

Before we get too excited about these results, it's important to point out this is an open label study with no placebo arm. The company reports "We are pleased to report a significant and sustained antidepressant response in patient follow up three months 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. The scientific manuscript has recently been submitted to the prestigious British Journal of Psychiatry for peer review and publishing. MindBio is the only organization in the world that is running multiple Phase 2B clinical trials with Government and Regulatory approvals for take-home use of a psychedelic medicine. 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." And an additional report commented "According to the company’s announcement on Monday, the trial achieved its primary efficacy endpoint, with participants experiencing a mean 14.1 point reduction in the Montgomery-Asberg Depression Rating Scale (MADRS), which comes out to a 60% decrease in depressive symptoms. Additionally, 53% of the participants were reported to have achieved complete remission of depression symptoms. “These Phase 2 trial results are transformative for the Company as it takes its next steps into late-stage pharma,” CEO Justin Hanka said in a statement. For the study, participants self-administered microdoses of a proprietary form of Lysergic Acid Diethylamide (LSD) over an eight-week period. MindBio said that MB22001 was well tolerated by participants, with no severe or serious adverse events related to the treatment reported. The finding is meaningful as it suggests the potential for safe, at-home use of microdosed psychedelics under controlled conditions."

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