MB22001 is a proprietary and self-titratable form of LSD that has been formulated for safe, take-home use by patients suffering from depression.
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MindBio Therapeutics Corp. said its microdosing formulation MB22001 has achieved shelf stability at room temperature for 12 months.
MB22001 is a proprietary and self-titratable form of LSD that has been formulated for safe, take-home use by patients suffering from depression, according to the company. An in-home patient trial is underway.
“The stability data for MB22001 is significant in MindBio’s quest to make psychedelic medicines readily available in the form of microdoses for take-home use,” MindBio said in a news release. “The company’s investment and scientific thesis is that small, take-home microdoses is the most scalable way to use psychedelic medicines to treat mental-health conditions.”
The sub-hallucinogenic microdoses “have a profound impact on mood and subjective feelings of well-being, energy and happiness,” the company added, “and once taken, patients can get on with their day.”
Ensuring an adequate shelf life is a critical component for regulatory compliance and ease of use by patients, MindBio noted.
“Having validated 12 months of shelf life in normal conditions, MindBio is able to guarantee that MB22001 remains safe and effective for patients during this period and will continue to assess stability of the medicine as time progresses,” the company explained in a news release. “Stability testing helps uphold product quality and protect patient safety, which are key regulatory requirements.”
Multiple Phase 2B clinical trials for MB22001 are in progress.
Previously released data from a Phase 2A depression trial reported improvements in MADRS Score (Montgomery-Asberg Depression Rating Scale) indicating an overall 60% decrease in depressive symptoms at the end of the treatment period and a 53% complete remission from depression, according to MindBio.
The company has reported a sustained antidepressant response of MB22001 at one month and three months post-treatment cycle. Data from prior trials also indicates improvements in a range of secondary outcome measures following an eight-week treatment course with MB22001, according to MindBio.
“We are satisfied that MB22001 is shaping up to be a medicine with much promise for treating patients suffering from Major Depressive Disorder and this stability data is confirmatory that we have a commercially viable product for safe, long term home storage,” MindBio CEO Justin Hanka said in a news release.