Adam JacksonMindBio Therapeutics Corp. (CSE: MBIO) posted positive outcomes from its Phase 2a clinical trial involving the take-home microdosing of its depression treatment drug, MB22001.
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.
The trial’s success also marks MindBio as the only organization currently approved for the take-home use and handling of a psychedelic medicine in clinical trials, it said.
The company added that it has collected extensive data over three years from its clinical trials, including psychometric data, speech analytics, sleep, biometric, activity data, EEG, ECG, PK/PD, and DNA sampling. The dataset is intended to support the development of a “scalable, safe, and effective” treatment model for depression that can be tailored to individual patient needs.
“I must admit, the scale of the improvements in depressive symptoms even surprised me as we advance this novel medicine through late-stage clinical trials,” Hanka said in a LinkedIn post.
“A patient can self-administer MB22001 in titratable microdoses at home and then get on with their day and it’s exactly what we have been testing with regulatory support in clinical trials in the real world.”
