BioXcel Therapeutics Announces USPTO’s Allowance of Patent Application for Method of Treating Agitation in Alzheimer’s Disease Using Oromucosal Formulations of Dexmedetomidine

BioXcel Therapeutics, Inc. recently announced the United States Patent and Trademark Office (USPTO) has allowed US Patent Application No. 17/496,470 with claims pertaining to a method of treating agitation in patients with Alzheimer’s disease using the oromucosal administration of 60 mcg of dexmedetomidine in a water-soluble dosage form. The broad claims encompass film formulations such as BXCL501 (sublingual dexmedetomidine), tablets, or wafers. The patent, when issued, is expected to have an expiration date of Dec. 29, 2037, subject to patent term adjustment (PTA), patent term extension (PTE), and terminal disclaimers.

The company also announced that it has received an issue notification from the USPTO for US Patent Application No. 17/993,422, from which US Patent No. 11,890,272 (the 272 patent) is expected to issue on Tuesday, Feb. 6, 2024. The 272 patent claims a method of treating agitation associated with schizophrenia or bipolar disorder through oromucosal administration of about 120 mcg to about 180 mcg of dexmedetomidine where the patient has a QT interval of less than 470 msec. This patent, when issued, is expected to have an expiration date of July 17, 2040, subject to PTA, PTE, and terminal disclaimers. It will be submitted for listing in the US FDA Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book) in addition to the seven currently listed US patents for IGALMI (dexmedetomidine) sublingual film. Collectively, these eight patents will in general extend patent protection for IGALMI until Jan. 12, 2043.

“We continue to build a robust intellectual property (“IP”) portfolio that supports our strategic focus of expanding the BXCL501 indication for the potential acute treatment of agitation associated with Alzheimer’s disease in the at-home and care settings,” said Vimal Mehta, Ph.D., CEO of BioXcel Therapeutics. “At the same time, we have strengthened the IP portfolio for our marketed product IGALMI and reinforced our strategy into the at-home treatment of bipolar disorders or schizophrenia-related agitation. Through this additional patent protection and expected initiation of our two upcoming late-stage Phase 3 registrational trials, we believe we are well-positioned to potentially expand our market opportunities for addressing the full spectrum of agitation in all treatment settings and bringing important new and needed treatment options to patients and caregivers.”

In indications other than those approved by the US FDA as IGALMI (dexmedetomidine) sublingual film, BXCL501 is an investigational proprietary, orally dissolving film formulation of dexmedetomidine, a selective alpha-2 adrenergic receptor agonist. BioXcel Therapeutics believes that BXCL501 potentially targets an important mediator of agitation, and the Company has observed anti-agitation results in multiple clinical trials across several neuropsychiatric disorders. BXCL501 is under investigation by BioXcel Therapeutics for the acute treatment of agitation associated with dementia due to probable Alzheimer’s disease and for the acute treatment of agitation associated with bipolar I or II disorder or schizophrenia in the at-home setting. The safety and efficacy of BXCL501 for these investigational uses have not been established. BXCL501 has been granted Breakthrough Therapy designation by the FDA for the acute treatment of agitation associated with dementia and Fast Track designation for the acute treatment of agitation associated with schizophrenia, bipolar disorders, and dementia.

BioXcel Therapeutics, Inc. (Nasdaq: BTAI) is a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience. Its wholly owned subsidiary, OnkosXcel Therapeutics, is focused on the development of medicines in immuno-oncology. The company’s drug re-innovation approach leverages existing approved drugs and/or clinically validated product candidates together with big data and proprietary machine learning algorithms to identify new therapeutic indications. For more information, visit bioxceltherapeutics.com.