BioXcel Therapeutics Inc (NASDAQ: BTAI) made a new high in yesterday’s session, and closed the day with gains of 40.35%. This followed the company’s announcement that it had started its Sub-Lingual Dexmedetomidine in Agitation Associated with Schizophrenia and Bipolar disorder study (SERENITY) program. The two-phase studies are for treating acute agitation in patients with schizophrenia and bipolar using the company’s treatment called BXCL501. The company expects to receive data from these trials in mid-2020.
Commenting on the progress, the CEO, Vimal Mehta stated that, the start of SERENITY trials was a major step towards their goal of offering an effective and safe treatment for people dealing with agitation that comes with schizophrenia and bi-polar. He added that, handling agitation in people suffering from these disorders is a big challenge to all involved, including physicians and the patient’s caregivers.
He further stated that, BXCL501 was designed in a way that it is non-invasive, acts quickly, and may overcome the challenges that come with the existing standards of care. He added that, the company believes the treatment gives patients a calming effect, without the need for excessive sedation that might hurt the relationship that exists between the patient and the caregiver.
The company’s studies for this treatment are randomized, and double-blind. They are also placebo-controlled and will involve 750 patients aged between 18 and 75. The company intends to take in patients with schizophrenia linked agitation and that each will either receive BXCL501 or a placebo. The dosage will either be 120 mg of the treatment or 180mg of the placebo.
The main endpoint of the trial is to cut down on acute agitation when measured by the positive and negative syndrome scale. Its main secondary endpoint is to determine the earliest point of agitation.
Looking at its price action, the SERENITY studies announcement pushed a stock that was already in an upside trajectory higher. In the day, it traded between a low of $10.52 and a high of $14.80 before closing the day at $14.61. Volumes in the day stood at 680.2k.
About BioXcel Therapeutics Inc
BioXcel Therapeutics Inc is a biopharma company that develops new treatments in the areas of immune-oncology and neuroscience. It is based in New Haven, Connecticut.