BioXcel Therapeutics Announces Initiation of Pivotal Phase 3 Studies of BXCL501 for Acute Treatment of Agitation in Patients with Schizophrenia and Bipolar Disorder

NEW HAVEN, Conn., Dec. 30, 2019 (GLOBE NEWSWIRE) -- BioXcel Therapeutics (a??BTIa?? or a??Companya??) (Nasdaq: BTAI), a clinical-stage biopharmaceutical company utilizing artificial intelligence approaches to identify and advance the next wave of medicines in neuroscience and immuno-oncology, today announced the initiation of its SERENITY (Sub-Lingual DExmedetomidine in Agitation Associated With SchizophRENIa and Bipolar Disorder STudY) program, two Phase 3 studies of BXCL501 for the acute treatment of agitation in patients with schizophrenia and bipolar disorder. Topline data from both Phase 3 trials are expected in mid-2020.
a??The initiation of the SERENITY trials represents a critical next step in our aim to provide a safe and effective therapy to millions of individuals who suffer from agitation associated with schizophrenia and bipolar disorder,a?? commented Vimal Mehta, Chief Executive Officer of BTI. a??Managing agitation in patients with neuropsychiatric disorders is a major challenge for both physicians and caregivers. BXCL501, designed as a non-invasive, fast acting therapy, may be able to overcome the limitations associated with current standards of care, as we believe it provides calming without excessive sedation while protecting the caregiver patient relationship.a??The SERENITY studies are randomized, double-blinded, placebo-controlled, adaptive trials of up to 750 patients 18 to 75 years of age. SERENITY I will enroll patients with agitation associated with schizophrenia, with each arm receiving either BXCL501 at 120 micrograms, 180 micrograms or a placebo. SERENITY II will evaluate patients with agitation associated with bipolar disorder, also with each of three arms receiving either BXCL501 at 120 micrograms, 180 micrograms or a placebo. The primary endpoint of the trials is reducing acute agitation measured by the Positive and Negative Syndrome Scale, examining the Excited Component (a??PECa??) change from baseline compared to placebo. A key secondary endpoint includes determining the earliest time where an effect on agitation is apparent as measured by the change from baseline in PEC total score.About Agitation in Neuropsychology
Agitation is a common and difficult to manage symptom associated with a number of psychiatric conditions, including schizophrenia and bipolar disorder. It is estimated that approximately 19 million people are at risk of agitation and 8.3 million in the U.S. suffer from agitation each year, costing approximately $40 billion annually in treatment related expenses. Early identification and prompt intervention to relieve agitation are essential to avoid symptomatic escalation and emergence of aggression. Recent consensus guidelines emphasize the need for non-coercive management strategies to protect the therapeutic alliance between patients and their healthcare providersa??an alliance that is critical for the effective management of chronic psychiatric conditions. A non-invasive therapy that causes rapid symptom relief and de-escalates agitation may be necessary to avoid the costly and traumatic use of coercive techniques, like physical restraint and seclusion, which require admission and prolonged hospitalization.About the PEC (PANSS-EC or the Positive and Negative Syndrome Scale-Excitatory Component) Score for Agitation
The PEC score is a validated regulatory endpoint for measuring acute agitation in schizophrenia and bipolar patients. This scale is used in clinical research to rate the severity of a patienta??s acute agitation. The PEC score is comprised of 5 elements associated with agitation: poor impulse control, tension, hostility, uncooperativeness, and excitement; each scored 1 (minimum) to 7 (maximum). The PEC is the sum of these 5 subscales and thus ranges from 5 to 35.
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