NEW HAVEN, Conn., Feb. 12, 2021 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (BioXcel or the Company) (Nasdaq: BTAI), a clinical-stage biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology, today announced that the Company will host a virtual Key Opinion Leader (KOL) event on Friday, February 19, 2021 from 11:00 am ET to 2:00 pm ET. The event aims to highlight BXCL501, the Companys investigational, proprietary, orally dissolving thin film formulation of dexmedetomidine (Dex), and its potential as a treatment option for multiple neuropsychiatric conditions.
BioXcels management team will be joined by leading experts for each indication to discuss the significant unmet medical need and BXCL501s potential to change the treatment paradigm.
KOL Presenters Include:
Schizophrenia/Bipolar Related Agitation
Dementia Related Agitation
Opioid Withdrawal Symptoms
Delirium Related Agitation
A live webcast of the event will be accessible through the Investors section of the Companys website at http://www.bioxceltherapeutics.com on February 19th at 11:00 am ET. Following the event, the webcast will be archived on the Companys website for at least 30 days.
About BXCL501
BXCL501 is an investigational, proprietary, orally dissolving thin film formulation of dexmedetomidine, a selective alpha-2a receptor agonist for the treatment of agitation and opioid withdrawal symptoms. BioXcel believes that BXCL501 directly targets a causal agitation mechanism, and the Company has observed anti-agitation results in multiple clinical studies across several neuropsychiatric disorders. BXCL501 has been granted Fast Track Designation by the U.S. Food and Drug Administration for the acute treatment of agitation in patients with schizophrenia, bipolar disorders, and dementia. BXCL501 has been studied in two Phase 3 trials (SERENITY I and II) for the acute treatment of schizophrenia related agitation and bipolar disorder related agitation, respectively, and in a Phase 1b/2 trial (TRANQUILITY) for the acute treatment of dementia related agitation. This product candidate is also currently being evaluated in a Phase 1b/2 study (RELEASE) for the treatment of opioid withdrawal symptoms, with plans to initiate a Phase 2 trial in hospitalized patients suffering from delirium related agitation within the next several months.
BioXcel Therapeutics, Inc.
BioXcel Therapeutics, Inc. is a clinical stage biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology. BioXcels 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 indices. BioXcels two most advanced clinical development programs are BXCL501, an investigational, proprietary, orally dissolving thin film formulation of dexmedetomidine for the treatment of agitation and opioid withdrawal symptoms, and BXCL701, an investigational, orally administered, systemic innate immunity activator in development for the treatment of aggressive forms of prostate cancer and advanced solid tumors that are refractory or treatment nave to checkpoint inhibitors. For more information, please visit http://www.bioxceltherapeutics.com.
Forward-Looking Statements
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements in this press release include but are not limited to BXCL501s potential as a treatment option for multiple neuropsychiatric conditions. When used herein, words including anticipate, being, will, plan, may, continue, and similar expressions are intended to identify forward-looking statements. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance, or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking. All forward-looking statements are based upon BioXcels current expectations and various assumptions. BioXcel believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain.
BioXcel may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various important factors, including, without limitation, its limited operating history; its incurrence of significant losses; its need for substantial additional funding and ability to raise capital when needed; its limited experience in drug discovery and drug development; its dependence on the success and commercialization of BXCL501 and BXCL701 and other product candidates; the failure of preliminary data from its clinical studies to predict final study results; failure of its early clinical studies or preclinical studies to predict future clinical studies; its ability to receive regulatory approval for its product candidates; its ability to enroll patients in its clinical trials; undesirable side effects caused by BioXcels product candidates; its approach to the discovery and development of product candidates based on EvolverAI is novel and unproven; its exposure to patent infringement lawsuits; its ability to comply with the extensive regulations applicable to it; impacts from the COVID-19 pandemic; its ability to commercialize its product candidates; and the other important factors discussed under the caption Risk Factors in its Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2020, as such factors may be updated from time to time in its other filings with the SEC, which are accessible on the SECs website at http://www.sec.gov and the Investors section of our website at http://www.bioxceltherapeutics.com.
These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent managements estimates as of the date of this press release. While BioXcel may elect to update such forward-looking statements at some point in the future, except as required by law, it disclaims any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing BioXcels views as of any date subsequent to the date of this press release.
Contact Information:
BioXcel Therapeutics, Inc.
http://www.bioxceltherapeutics.com
Investor Relations:
Mary ColemanBioXcel Therapeutics, VP of Investment RelationsMColeman@bioxceltherapeutics.com1.475.238.6837
John GrazianoSolebury Troutjgraziano@soleburytrout.com1.646.378.2942
Media:
Julia DeutschSolebury Troutjdeutsch@soleburytrout.com1.646.378.2967
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