MindBio Therapeutics Corp. reported 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). The company reported 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 organization 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.