BioXcel Therapeutics Starts Pivotal Phase 3 Studies

BioXcel Therapeutics (“BTI” or “Company”) (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.

“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,” commented Vimal Mehta, Chief Executive Officer of BTI. “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.”

https://www.biospace.com/article/releases/bioxcel-therapeutics-announces-initiation-of-pivotal-phase-3-studies-of-bxcl501-for-acute-treatment-of-agitation-in-patients-with-schizophrenia-and-bipolar-disordertopline-results-expected-in-mid-2020/