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BioXcel Therapeutics
Announces Oral and Poster Presentations at the 2024 American Society of Clinical Psychopharmacology (ASCP) Annual Meeting
2024-05-21
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NEW HAVEN, Conn., May 21, 2024 (GLOBE NEWSWIRE) --
BioXcel Therapeutics, Inc.
(Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience and immuno-oncology, today announced that Rob Risinger, M.D., Chief Medical Officer of
Neuroscience
, will deliver oral and poster presentations at the 2024 American Society of Clinical Psychopharmacology (ASCP) Annual Meeting. The meeting will take place May 28 to 31, 2024 in Miami Beach, FL. ASCP presentation details are below: Oral Presentation Title: An Exploratory Comparison of Sublingual
Dexmedetomidine
with
Quetiapine
in Healthy Elderly Subjects Date/Time: May 28, 2024, 2:20-2:30 p.m. ET Location: Salon 3 Poster Presentation Title: Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study of
BXCL501
with Concomitant Treatment with Anti-Depressant in Healthy Volunteers Date/Time: May 29, 2024, 11:15 a.m.-1:00 p.m. ET Location: Salon 4 Poster Presentation Title: A Phase Ib/II Multicenter, Randomized, Double Blind, Placebo-Controlled, Ascending Dose Finding Study of
BXCL501
in Agitation Associated with
Dementia
Date/Time: May 30, 2024, 12:30-2:15 p.m. ET Location: Salon 4 About
BXCL501
In indications other than those approved by the
U.S. Food and Drug Administration (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
. AboutIGALMI™(dexmedetomidine)sublingualfilm INDICATION
IGALMI
™ (
dexmedetomidine
) sublingual film is a prescription medicine, administered under the supervision of a health care provider, that is placed under the tongue or behind the lower lip and is used for the acute treatment of
agitation
associated with
schizophrenia
and
bipolar disorder
I or II in adults. The safety and effectiveness of
IGALMI
has not been studied beyond 24 hours from the first dose. It is not known if
IGALMI
is safe and effective in children. IMPORTANTSAFETYINFORMATION IGALMIcancauseserioussideeffects,including: Decreased blood pressure, low blood pressure upon standing, and slower than normal heart rate, which may be more likely in patients with low blood volume,
diabetes
, chronic high blood pressure,andolderpatients.
IGALMI
is taken under the supervision of a healthcare provider who will monitor vital signs (like blood pressure and heart rate) and alertness after
IGALMI
is administered to help prevent falling or fainting. Patients should be adequately hydrated and sit or lie down after taking
IGALMI
and instructed to tell their healthcare provider if they feel dizzy, lightheaded, or faint. Heart rhythm changes (QT interval prolongation).
IGALMI
should not be given to patients with an abnormal heart rhythm, a history of an irregular heartbeat, slow heart rate, low potassium, low magnesium, or taking other drugs that could affect heart rhythm. Taking IGALMI with a history of abnormal heart rhythm can increase the risk of torsades de pointes and sudden death. Patients should be instructed to tell their healthcare provider immediately if they feel faint or have heart palpitations. Sleepiness/drowsiness. Patients should not perform activities requiring mental alertness, such as driving or operating hazardous machinery, for at least 8 hours after taking
IGALMI
. Withdrawalreactions,tolerance,anddecreasedresponse/efficacy.
IGALMI
was not studied for longer than 24 hours after the first dose. Physical dependence, withdrawal symptoms (e.g.,
nausea
,
vomiting
,
agitation
), and decreased response to
IGALMI
may occur if
IGALMI
is used longer than 24 hours. Themostcommonsideeffects of
IGALMI
in clinical studies were
sleepiness
or
drowsiness
, a prickling or tingling sensation or numbness of the mouth,
dizziness
,
dry mouth
, low blood pressure, and low blood pressure upon standing. These are not all the possible side effects of
IGALMI
. Patients should speak with their healthcare provider for medical advice about side effects. Patients should tell their healthcare provider about their medical history, including if they suffer from any known heart problems, low potassium, low magnesium, low blood pressure, low heart rate,
diabetes
, high blood pressure, history of
fainting
, or
liver impairment
. They should also tell their healthcare provider if they are pregnant or breastfeeding or take any medicines, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Patients should especially tell their healthcare provider if they take any drugs that lower blood pressure, change heart rate, or take anesthetics, sedatives, hypnotics, and opioids. Everyone is encouraged to report negative side effects of prescription drugs to the
FDA
. Visit or call 1-800-FDA-1088. You can also contact
BioXcel Therapeutics, Inc.
at 1-833-201- 1088 or medinfo@bioxceltherapeutics.com. Please see full Prescribing Information. About
BioXcel Therapeutics, Inc.
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, please visit bioxceltherapeutics.com. Forward-LookingStatements This press release includes “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended. All statements contained in this press release other than statements of historical fact should be considered forward-looking statements, including, without limitation, statements related to the Company’s planned participation in and content of the Company’s presentations at the ASCP Annual Meeting. When used herein, words including “anticipate,” “believe,” “can,” “continue,” “could,” “designed,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, though not all forward-looking statements use these words or expressions. 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 the Company’s current expectations and various assumptions. The Company believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. The Company 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; the impact of the reprioritization; its significant indebtedness, ability to comply with covenant obligations and potential payment obligations related to such indebtedness and other contractual obligations; the Company has identified conditions and events that raise substantial doubt about its ability to continue as a going concern; its limited experience in drug discovery and drug development; risks related to the TRANQUILITY program; its dependence on the success and commercialization of IGALMI™, BXCL501, BXCL502, BXCL701 and BXCL702 and other product candidates; its lack of experience in marketing and selling drug products; the risk that IGALMI or the Company’s product candidates may not be accepted by physicians or the medical community in general; the Company still faces extensive and ongoing regulatory requirements and obligations for IGALMI; 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 the Company’s product candidates; its novel approach to the discovery and development of product candidates based on EvolverAI; the significant influence of and dependence on BioXcel LLC; its exposure to patent infringement lawsuits; its reliance on third parties; its ability to comply with the extensive regulations applicable to it; impacts from data breaches or cyber-attacks, if any; risks associated with the increased scrutiny relating to environmental, social and governance (ESG) matters; risks associated with federal, state or foreign health care “fraud and abuse” laws; and its ability to commercialize its product candidates, as well as the important factors discussed under the caption “Risk Factors” in its Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2024, as such factors may be updated from time to time in its other filings with the SEC, which are accessible on the SEC’s website at . 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 management’s estimates as of the date of this press release. While the Company 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 the Company’s views as of any date subsequent to the date of this press release. ContactInformation Corporate
BioXcel Therapeutics
Erik Kopp 1.203.494.7062 ekopp@bioxceltherapeutics.com Investor Relations
BioXcel Therapeutics
Brennan Doyle 1.475.355.8462 bdoyle@bioxceltherapeutics.com Media
Russo Partners
David Schull 1.858.717.2310 David.schull@russopartnersllc.com Scott Stachowiak 1.646.942.5630 Scott.stachowiak@russopartnersllc.com Source:
BioXcel Therapeutics, Inc.
IGALMI
™ is a trademark of
BioXcel Therapeutics, Inc.
BT BIOXCEL THERAPEUTICS is a registered trademark of
BioXcel Therapeutics, Inc.
All other trademarks are the properties of their respective owners. Copyright © 2024,
BioXcel Therapeutics, Inc.
All rights reserved.
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机构
BioXcel Therapeutics, Inc.
NeuroScience, Inc.
US Food & Drug Administration
[+2]
适应症
痴呆
精神障碍
躁动
[+12]
靶点
-
药物
盐酸右美托咪定
富马酸喹硫平
Alpha 2 adrenoreceptor agonists(Allergan)
标准版
¥
16800
元/账号/年
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