Agitation is a major symptom and complication of neurological conditions and it represents a large healthcare burden for both patients and care givers.

Although it affects people with schizophrenia and bipolar disorder, BioXcel Therapeutics CEO and founder Vimal Mehta sees agitation as particularly challenging in Alzheimer’s disease as these are usually fragile, elderly patients. This a common symptom of Alzheimer’s because the disease is associated with significant flux in patients’ lives as they lose their ability to compute new information and stimuli.

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Despite the impact on the quality of life and wellbeing of patients and their carers, there are few effective and well-tolerated drugs available to combat agitation symptoms. The most common drugs used are anti-psychotics, which Mehta explains come with black box warnings due to their harmful side effects. Anti-psychotics are also widely deemed to be ineffective in managing agitation symptoms in dementia patients.

Improving treatment and management of agitation

BioXcel is seeking to combat this unmet need with its non-invasive, anti-agitation drug BXCL501. Discovered using artificial intelligence (AI) algorithms, BXCL501 has a novel, broad mechanism of action, which makes it effective against a “central mechanism in the brain”, meaning it could be effective across various neurological conditions.

BXCL501 has achieved a human proof-of-concept in Alzheimer’s and a Phase Ib study of the drug in this indication was initiated in the final quarter of 2019. This is a dose escalation study to figure out which doses are tolerable in Alzheimer’s and what the precise efficacy will be.

In addition, the US-based company wants to support efforts to pre-empt and manage Alzheimer’s agitation through the use of a wearable device and the development of predictive AI algorithms.

“We want to make sure that we manage these patients in a manner so you can avoid the highly aggressive state [of agitation] where they [can] become harmful to themselves, as well as to caregivers,” Mehta explains. “We thought it was a unique opportunity for us, as an AI company to combine a wearable device [such as an Apple Watch] with our drug, to prevent and then treat agitation in Alzheimer’s patients.”

Spotlight on BXCL501 to treat agitation

BioXcel’s AI platform crunched “millions of publications in a very short time and created a metadata, [which is essentially] the relationship map between the disease, drug, underlying mechanism, mode of action, pharmacology and beyond” to identify BXCL501 and its mechanism of action related to norepinephrine. The company believes the drug’s novel mechanism of action creates a calming effect without excessive sedation.

“When agitation happens it causes the release of a chemical called norepinephrine; our drug [BXCL501] stops the release of that chemical,” Mehta explains. “We believe we are targeting the causal mechanism of agitation.”

The active pharmaceutical ingredient of BXCL501 has already been marketed by Pfizer as a sedative anaesthetic to be administered through an IV before surgery.

However, to make this drug more appropriate for agitated patients, no matter whether they have Alzheimer’s or schizophrenia, BioXcel converted it into a sublingual film that is placed under the tongue and has a minty flavour.

“An agitated patient won’t be stable enough to do an IV,” Mehta says, adding that the film allows patients to self-administer the drug. The discovery of this clinical pathway and the subsequent reformulation of the treatment is an example of AI insights benefitting from being combined with human pharmaceutical expertise.

Predicting agitation with AI algorithms and a wearable device

Although BXCL501 was developed across various indications, the company is specifically working on improving the management of agitation in Alzheimer’s.

“Alzheimer’s patients particularly have certain pre-agitation symptoms, like skin conductance, higher heart rate and blood pressure and [erratic] movement of limbs,” Mehta notes. “There parameters given an indication that a patient is going to get agitated.”

BioXcel saw it as an opportunity to make use of new, commonly available wearable devices and associated patient data to monitor these different parameters.

Currently, BioXcel is doing its proof-of-concept with the Apple Watch due to the robustness of this platform, however, Mehta notes that “as we move along, we will make a decision [on] whether the Apple Watch is ideal or whether we need to adopt another technology.”

On top of the wearable, BioXcel is “developing algorithms…to predict accurately that a patient is going to experience agitation” and alerting caregivers in advance.

This will allow them to potentially administer BXCL501 before the onset of agitation and escalation to its most intense, highly aggressive where patients can harm themselves or others. Data from a feasibility study of this triple approach is expected to be available soon to determine how precisely the algorithms can predict agitation in Alzheimer’s patients.

Mehta believes BioXcel’s strategy is particularly promising because usually when a company creates a technology that can predict something, the regulators ask “what are you going to do next? Whereas we have BXCL501 to answer that.” Combining the wearable, predictive algorithms and BXCL501 “can provide much better patient management solutions to treat Alzheimer’s agitation across the globe”.