BioXcel Therapeutics Announces First Patients Dosed in SERENITY III Phase 3 Trial for | BTAI Message Board Posts


BioXcel Therapeutics, Inc.

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Msg  33 of 42  at  12/3/2022 12:34:24 PM  by

jerrykrause


BioXcel Therapeutics Announces First Patients Dosed in SERENITY III Phase 3 Trial for

 Pharma & Healthcare Monitor Worldwide
 
 

BioXcel Therapeutics Announces First Patients Dosed in SERENITY III Phase 3 Trial for Acute Treatment of Agitation in Adults with Bipolar I or II Disorder or Schizophrenia

 
 

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 13 patients have been dosed in Part 1 of the pivotal Phase 3 SERENITY III trial investigating at-home use of BXCL501 (dexmedetomidine) sublingual film, the Companys proprietary, orally dissolving film, for agitation associated with bipolar I or II disorder or schizophrenia.

Evaluating BXCL501 for at-home use is an exciting and important milestone that potentially expands the market opportunity for the treatment of agitation and drives the growth of our neuroscience franchise, said Robert Risinger, M.D., Chief Medical Officer, Neuroscience of BioXcel Therapeutics. We anticipate top-line data from SERENITY III as well as our TRANQUILITY II trial for Alzheimers-related agitation in the first half of 2023. These two near-term pivotal data readouts further reinforce the potential of BXCL501 to address the unmet medical needs of millions of patients.

The treatment of agitation represents a significant market opportunity. There are approximately 39 million reported agitation episodes that occur in the U.S. each year related to bipolar disorders and schizophrenia.1-4 23 million of these episodes occur outside of the institutional setting, potentially more than doubling the current market opportunity for BXCL501.

SERENITY III is a two-part, double-blinded, placebo-controlled pivotal study designed to evaluate BXCL501 60mcg dose for at-home use. This strategic trial design follows a Type B meeting with the U.S. Food and Drug Administration and observed dose-dependent responses in a prior Phase 1/2b study assessing a range of doses. The first part of the study is similar to SERENITY I and II and designed to assess the efficacy and safety of a 60mcg dose in acutely agitated patients with bipolar disorder or schizophrenia in a monitored setting. The primary efficacy endpoint is the change from baseline in Positive and Negative Syndrome Scale-Excitatory Component (PEC) total score at two hours after dosing compared to placebo. In Part 1, approximately 200 patients will be enrolled at up to approximately 20 clinical sites in the U.S. The second part of the study is designed to assess the safety of 60mcg dose compared to placebo when self-administered at home. SERENITY III will utilize many of the same investigators and clinical sites as SERENITY I and II.

About BXCL501

BXCL501 is a 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 Agitation Associated with Bipolar Disorders and Schizophrenia

Agitation is a common and difficult-to-manage symptom associated with bipolar I or II disorder or schizophrenia. Early identification and prompt intervention to relieve agitation are essential to avoid symptomatic escalation and the emergence of aggression. Expert consensus best-practice guidelines have recommended that agitation should be treated by a combination of behavioral calming techniques, verbal de-escalation, and medications that are voluntarily accepted by patients without coercion. The goal of using medication is to calm the patient so that he or she can be more accurately assessed by clinicians. Medication used in this manner is consistent with current guidelines, which state that the proper endpoint of medication administration is calming without inducing sleep. The Company believes this approach may help avoid the costly and traumatic use of coercive techniques like physical restraint and seclusion, which may result in admission and prolonged hospitalization.5

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 indices. 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.

 


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