BioXcel Therapeutics Announces Promising Topline Results from Clinical Trial for Bipolar Disorders or Schizophrenia Treatment
BioXcel Therapeutics (Nasdaq: BTAI) has announced promising results from a Phase 3 clinical trial of BXCL501, its proprietary, orally dissolving film of dexmedetomidine as a treatment for agitation in bipolar disorders or schizophrenia.
BXCL501 was well tolerated and demonstrated favorable safety results supporting potential for at-home use.
Highlights
SERENITY III is a two-part, double-blinded, placebo-controlled pivotal study designed to evaluate BXCL501 in acutely agitated adult patients with bipolar disorders or schizophrenia for at-home use.
Clinically meaningful efficacy results were observed with half (60mcg) of the approved dose of IGALMI™.
BioXcel is targeting up to an additional 23 million annual agitation episodes in bipolar disorder and schizophrenia patients in the at-home setting with its treatment. This would potentially more than double the company’s current market opportunity.
BXCL501 would represent the first-ever FDA approved therapy for at-home use in this indication, if approved.
About BioXcel Therapeutics
BioXcel Therapeutics, Inc. is a biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and 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. The Company’s 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.
