Drug development continues for the Bright Minds Biosciences (CSE: DRUG) lead product. The firm this morning published positive results from a recent 28-day toxicity study conducted on its novel formulation, BMB-101, which is currently being designed for the treatment of Dravet Syndrome.
Conducted by the firms contract research partner ITR Laboratories Canada, the study consisted of a 28-day process. The process saw twice daily oral administrations of the compound in both mice and dogs in compliance with Good Laboratory Practices.
Within the study, doses of up to 40 and 30 milligrams per kilogram per day in mice and dogs, respectively, were said to be well tolerated at all dose levels. At these levels there is said to have been no major toxic effects after a 28 day period, which includes a lack of any effect on target organs.
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The data collected from the 28 day study will now be utilized in establishing safety criteria for determining the starter dose levels in human subjects.
“We are delighted to have completed this important milestone, which is pivotal for supporting our forthcoming first-in-human clinical trial, currently expected to begin in 2Q22. We have now officially entered the clinical development stage for our lead product, BMB-101, which represents an exciting new chapter for the Company and, hopefully, therapeutic alternative for patients suffering from Dravet Syndrome.”
Bright Minds Biosciences last traded at $2.01 on the CSE.
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