BioXcel Therapeutics has announced plans to initiate two Phase III clinical trials of BXCL501 for the acute treatment of agitation in schizophrenia and bipolar disorder patients.

The announcement comes after the company’s end-of-Phase II meeting with the US Food and Drug Administration (FDA).

BXCL501 is a sublingual formulation of dexmedetomidine, which is a selective alpha-2a receptor agonist to treat acute agitation.

The drug is believed to directly act on a causal agitation mechanism. BioXcel said that BXCL501 demonstrated anti-agitation effects in clinical studies for various neuropsychiatric conditions.

Together called the SERENITY programme, the randomised, double-blinded, placebo-controlled, adaptive Phase III trials will enrol up to 750 patients aged 18 to 75.

SERENITY I will assess 120µg and 180µg of BXCL501 compared to placebo in schizophrenia patients with agitation, while SERENITY II will evaluate the doses in patients with bipolar disorder-related agitation.

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Set to be commenced by the end of this year, top-line data from the Phase III trials are expected to be reported in mid-2020.

The primary endpoint will be the decrease in acute agitation symptoms, measured as the Excited Component (PEC) change from baseline using the Positive and Negative Syndrome Scale.

The key secondary endpoint includes the earliest time when an effect on agitation is apparent, determined by the change in PEC total score from baseline.

According to the company, the Phase III programme builds on positive data from the Phase Ib study in schizophrenia patients. Results showed a statistically significant and clinically meaningful decrease in PEC score with the 120 and 180µg doses.

BioXcel Therapeutics CEO Vimal Mehta said: “Our pivotal Phase III studies are designed to support the regulatory approval of BXCL501 as a non-injectable, acute treatment for agitation in patients with schizophrenia and bipolar disorder.

“We’re highly encouraged by our interactions with the FDA, and are one step closer to providing physicians with a potentially more effective and easier-to-use therapy to help safely manage their patients.”

The company also intends to conduct a Phase Ib/II trial of BXCL501 in patients with agitation related to dementia.