BioXcel Therapeutics, Inc. (NASDAQ: BTAI), a biopharmaceutical company leveraging artificial intelligence in drug development, has secured a significant milestone in its intellectual property (IP) portfolio. The European Patent Office granted Patent No. 3,562,486 on March 13, 2024, covering a range of sublingual dosage forms, such as films, wafers, and tablets, for BioXcel’s dexmedetomidine treatment for agitation in dementia patients.
European patent grant dementia treatment
This European patent is a crucial addition to BioXcel’s extensive IP portfolio, which includes over 100 patent applications under prosecution and multiple issued patents. “The 486 patent aligns with our focus on expanding our patent portfolio for BXCL501 into Europe,” said Vimal Mehta, Ph.D., CEO of BioXcel Therapeutics. The company believes this strengthens their foundation for potential commercialization in various geographies, pending regulatory approval.
The European patent follows the recent allowance of a U.S. patent application for the treatment of agitation in Alzheimer’s disease patients using a water-soluble oromucosal administration of dexmedetomidine. Additionally, the U.S. Patent and Trademark Office allowed a patent application for a method of treating agitation with an oromucosal formulation of dexmedetomidine, expected to extend protection for BioXcel’s IGALMI™ sublingual film until January 12, 2043.
IGALMI™, a sublingual film formulation of dexmedetomidine, is currently approved for the acute treatment of agitation associated with schizophrenia and bipolar disorder I or II in adults. It is administered under healthcare provider supervision, and its safety and efficacy beyond 24 hours from the initial dose have not been studied. The most common side effects reported in clinical trials include sleepiness, dizziness, and low blood pressure.
BXCL501: Targeting Agitation Across Neuropsychiatric Disorders
BioXcel’s BXCL501 is an investigational film formulation of dexmedetomidine, targeting agitation across several neuropsychiatric disorders. It has received Breakthrough Therapy designation for the acute treatment of agitation associated with dementia and Fast Track designation for treating agitation related to schizophrenia, bipolar disorders, and dementia.
As a biopharmaceutical firm leveraging artificial intelligence in drug development, BioXcel Therapeutics is at the forefront of innovative approaches to addressing unmet medical needs. The company’s commitment to expanding its IP portfolio and pursuing regulatory approvals for its investigational therapies highlights its dedication to advancing patient care.
The granting of the European patent for BioXcel Therapeutics’ dementia treatment represents a significant milestone in the company’s IP strategy and its efforts to develop novel therapies for neuropsychiatric disorders. With a robust patent portfolio and promising investigational products like BXCL501, BioXcel is well-positioned to drive innovation and potentially commercialize its treatments in various global markets, subject to regulatory approvals.
