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BioXcel Therapeutics Provides Update on the Clinical Advancement of BXCL501 for the Acute Treatment of Agitation

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On Track to Initiate bXCL501 First-In-Human Pharmacokinetic (Bioavailability) and Safety Study

BioXcel Therapeutics, Inc. (“BTI”) (Nasdaq: BTAI), a clinical stage biopharmaceutical development company utilizing novel artificial intelligence approaches to identify the next wave of medicines across neuroscience and immuno-oncology, today provided an update on the Company’s progress advancing its lead neuroscience program, BXCL501, a proprietary, first-in-class sublingual thin film formulation of dexmedetomidine hydrochloride (“Dex”) being developed for the acute treatment of agitation.

BTI is on track to initiate an IND-opening Phase 1 pharmacokinetic (“PK”) and safety study with BXCL501 by the end of this year, following approval of its IND application. Prior to its recently completed pre-IND meeting with the Food and Drug Administration (“FDA”), BTI submitted a pre-IND briefing book containing regulatory, chemistry, manufacturing, controls (“CMC”) and non-clinical work, along with a proposed clinical study synopsis and a broader development plan. During the pre-IND meeting with the FDA, BTI received valuable feedback that will help guide further clinical development of BXCL501.

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Vimal Mehta, Ph.D., Chief Executive Officer of BTI commented, “We have made a number of advancements in the development of BXCL501 including  the recent successful completion of CMC. The planned initiation of the first-in-human PK and safety trial of BXCL501, a proprietary sublingual film formulation of Dex, will be a significant milestone. We expect to report data from this study in the first half of 2019, laying the foundation for a registration trial that will follow.”

Building on the positive data from the Phase 1 study of the intravenous (“IV”) formulation of Dex in healthy middle-aged and elderly participants announced earlier this year, BTI expects to report top-line data from the ongoing study of IV Dex in patients with schizophrenia and senile dementia of the Alzheimer’s type (SDAT) in the fourth quarter of this year.

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BTI plans to explore expanding the range of target indications for BXCL501 outside its current focus areas. Treatment of agitation remains a significant global healthcare challenge in patients with drug & alcohol withdrawal, delirium and post traumatic stress disorder (“PTSD”), as the currently available treatment options are suboptimal, invasive, difficult to administer and often pose safety issues.

BXCL501 is a first in class, sublingual film of dexmedetomidine, a selective alpha 2a receptor agonist for the treatment of acute agitation. BTI believes that BXCL501 directly targets a causal agitation mechanism and has demonstrated anti-agitation effects in preclinical and clinical studies. It has a well-established regulatory and reimbursement path in schizophrenia and bipolar disorder, as demonstrated by a previously-approved drug, Adasuve.

Agitation remains a growing global healthcare burden. The Company estimates the total direct financial cost of all aspects of care for agitation in Alzheimer’s disease to be approximately $40 billion per year. The Company believes approximately 5.0 million patients with Alzheimer’s disease, schizophrenia and bipolar disorder experience agitation in the U.S. Approximately 1.2 million of these patients experience mild to moderate agitation, and represent a potential patient population for treatment with BXCL501.

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