BioXcel Therapeutics (NASDAQ: BTAI) is a biotech company that is using artificial intelligence to identify neuroscience and immuno-oncology medicines.
The company announced positive results Monday from its BXCL501 Phase 1b trial.
Benzinga connected with BioXcel's CEO Dr. Vimal Mehta for more insight on the company's results and plans moving forward.
Benzinga: BioXcel's BXCL501 met its primary endpoint in a Phase 1b trial. How difficult was it for the drug to meet its endpoints in Phase 1b?
Mehta: We tested the drug in 135 patients using five different doses, and it met both primary and secondary endpoints. It was clinically meaningful, and we saw a statistically significant response which was P<0.0001 following a single dose of 180 mcg.
What this means is that if a company gets such data in a registration trial, they can then seek approval for the drug.
We are very excited that we got such a remarkable response to our drug with different doses. We now have three doses that demonstrated statistical significance in a recently completed trial. Currently, we are preparing to go to the FDA and have a conversation about initiating the Phase 3 pivotal trial for BXCL501.
Benzinga: Is the BXCL501 the only drug in development for schizophrenia?
Mehta: We are developing the BXCL501 drug to treat acute agitation resulting from schizophrenia, bipolar, dementia, Alzheimer's, delirium and opioid withdrawal symptoms. So, we are addressing the acute agitation, not the schizophrenia disease per se. But this is a huge unmet medical need which results in a $40-billion health care burden with 19 million people in the U.S. at risk of agitation and 8.3 million suffering from agitation.
We are targeting mild-to-moderate acute agitation patients with a sublingual form of the drug.
Benzinga: In addition to schizophrenia, what else can this drug be taken for?
Mehta: It is being developed to treat acute agitation and there are no optimal therapies that are easy to administer and are non-invasive.
BXCL501 is designed to treat agitation by reducing the activity of brain norepinephrine to drive the agitation response independent of the underlying disease conditions. This regulates the fight-or-flight response and is released during stress, which leads to patients suffering from agitation.
This is a pretty unique drug with a novel mechanism of action, and it is easy to use. The patient simply puts the BXCL501 under the tongue, it has a mint flavor and sticks. BXCL501 has potential as a non-invasive rapid treatment for agitation in a variety of neuropsychiatric disorders.
Benzinga: Is BXCL501 moving forward toward Phase 3? When do you expect BXCL501 to be available to the public?
Mehta: The Phase 3 trial is expected to initiate in the fourth quarter of 2019. These are short trials. We evaluated 135 patients in less than two months. We expect that the Phase 3 trial of 600 to 700 patients can be completed in four to six months. Then we will file for our new drug application (NDA) in the second half of 2020.
The new drug application process takes about eight to 10 months. So, this drug could become available to the patient sometime in 2021.
BioXcel shares were up 1.87% at $10.89 at the time of publication Friday.
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