BioXcel Therapeutics Announces First Patient Dosed in TRANQUILITY III Phase 3 Trial f | BTAI Message Board Posts


BioXcel Therapeutics, Inc.

  BTAI website

BTAI   /  Message Board  /  Read Message

 

 






Keyword
Subject
Between
and
Rec'd By
Authored By
Minimum Recs
  
Previous Message  Next Message    Post Message    Post a Reply return to message boardtop of board
Msg  34 of 42  at  12/22/2022 12:19:10 PM  by

jerrykrause


BioXcel Therapeutics Announces First Patient Dosed in TRANQUILITY III Phase 3 Trial f

 Pharma & Healthcare Monitor Worldwide
 

BioXcel Therapeutics Announces First Patient Dosed in TRANQUILITY III Phase 3 Trial for Acute Treatment of Agitation in Patients with Alzheimer's Disease

 
 

BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology, today announced that the first patient has been dosed in the pivotal Phase 3 TRANQUILITY III trial of BXCL501 (dexmedetomidine) sublingual film, the Companys proprietary, orally dissolving film, under investigation for the acute treatment of agitation in patients with Alzheimers disease (AD). AD is the most prevalent type of dementia in the U.S.5 The TRANQUILITY program includes two investigational studies, TRANQUILITY II and TRANQUILITY III, which are designed to evaluate the safety and efficacy of BXCL501 for the acute treatment of Alzheimers-associated agitation in adults 65 years and older in assisted living or residential care facilities and nursing homes.

The prevalence of Alzheimers disease is unfortunately increasing and there remains no FDA-approved product indicated for patients experiencing agitation associated with this condition, said Robert Risinger, M.D., Chief Medical Officer, Neuroscience of BioXcel Therapeutics. With two pivotal trials underway in our TRANQUILITY program, we are aiming to expand BXCL501s potential to treat the full spectrum of episodic and intermittent chronic agitation market, and address the costly health-care burden related to Alzheimers agitation.

There are approximately 100 million reported agitation episodes that occur in the U.S. each year related to Alzheimers disease.1 The number of adults over the age of 65 with AD is expected to double from 5.8 million in 2020 to 11.8 million in 2040 6, representing a significant and growing market opportunity for BXCL501. This potential opportunity is in addition to the current acute treatment of agitation associated with schizophrenia or bipolar I or II disorder market opportunity. Approximately 16 million episodes of schizophrenia and bipolar disorder-associated agitation occur in institutional settings and, when combined with at-home episodes, 23 million annually in the U.S.2-4

TRANQUILITY II and III will evaluate the safety and efficacy of BXCL501 in patients who experience agitation across diverse settings and across the range of dementia severity. Each trial will enroll approximately 150 patients with dementia ages 65 years and older who will self-administer 40mcg or 60mcg of BXCL501 or placebo under the supervision of a trained research staff member whenever agitation episodes occur over a three-month period. TRANQUILITY II will assess patients in assisted living or residential care facilities requiring minimal assistance with activities of daily living. TRANQUILITY III will assess patients residing predominantly in nursing homes with moderate to severe dementia who require moderate or greater assistance with activities of daily living. The primary efficacy endpoint for both studies is change in Positive and Negative Syndrome Scale-Excitatory Component (PEC) total score from baseline measured at two hours after the initial dose and subsequent doses.

About BXCL501

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 studies across several neuropsychiatric disorders. BXCL501 is under investigation for the acute treatment of agitation associated with bipolar I or II disorder or schizophrenia in the at-home setting, for the acute treatment of Alzheimers-related agitation, and as an adjunctive treatment for major depressive disorder. The safety and efficacy of BXCL501 for these investigational uses have not been established. BXCL501 has been granted Breakthrough Therapy designation 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.

About BioXcel Therapeutics, Inc.

BioXcel Therapeutics, Inc. is a biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology. The Companys 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. The Companys commercial product, IGALMI (developed as BXCL501), is a proprietary, sublingual film formulation of dexmedetomidine approved for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults. The safety and effectiveness of IGALMI has not been established beyond 24 hours from the first dose. For more information, please visit IGALMIhcp.com and also see the IGALMI full Prescribing Information. BXCL501 is under evaluation for at-home use for the acute treatment of agitation in bipolar and schizophrenia patients, for acute treatment of Alzheimers-related agitation, and as an adjunctive treatment for major depressive disorder. The safety and efficacy of BXCL501 for these uses have not been established. The Company is also developing BXCL502 as a potential therapy for chronic agitation in dementia. Under its subsidiary, OnkosXcel Therapeutics, the Company is developing BXCL701, an investigational, orally administered, systemic innate immune activator for the treatment of aggressive forms of prostate cancer. The safety and efficacy of BXCL502 and BXCL701 have not been established.

 


     e-mail to a friend      printer-friendly     add to library      
|  
Recs: 0  
   Views: 0 []
Previous Message  Next Message    Post Message    Post a Reply return to message boardtop of board




Financial Market Data provided by
.
Loading...