Pharma Focus Asia

BioXcel Therapeutics Announces BXCL501 Program Initiative for Prevention and Treatment of Acute Agitation using Wearable Digital Devices

Thursday, September 19, 2019

BioXcel Therapeutics, Inc., a clinical-stage biopharmaceutical development company utilizing novel artificial intelligence approaches to identify and advance the next wave of medicines in neuroscience and immuno-oncology, today announced a strategic plan to investigate the development of using wearable digital device technology such as the Apple Watch, with the goal of enhancing the prevention and treatment of agitation including, if approved, the administration of BXCL501 prior to the onset of agitation.

BioXcel Therapeutics plans to conduct a feasibility study with potential applications for uses in commercially available wearable digital devices to measure nervous and motor system activity relevant to both agitation and the mechanism of action of the Company’s drug candidate, BXCL501. BTI plans to leverage its core drug development expertise in neuroscience and the AI expertise of its parent company, BioXcel Corporation, and to collaborate with both clinical investigators and a third-party digital solutions provider. The goal of this collaborative effort is to use these data to develop an integrated patient management solution, which may enable early intervention for agitation via an analytic algorithm that predicts and identifies agitation. If successfully developed, such technology could potentially be used in conjunction with BXCL501 for prevention and early identification of agitation in patients with Alzheimer’s dementia and other medical conditions including delirium and PTSD.

“Utilizing predictive algorithms and developing related wearable device technology may enable the administration of BXCL501 prior to the onset of an agitation episode, which, if BXCL501 is approved, may reduce the burden on the patient and caregiver,” noted George Grossberg, Samuel W. Fordyce Professor and Director of Geriatric Psychiatry in the Department of Psychology at Saint Louis University School of Medicine. “By identifying the early onset of agitation, BXCL501 could potentially be administered more efficiently and, consequently, we believe has the potential to reduce medical costs and improve patient management with lower doses, applicable to a broader set of institutionalized elderly patients.”

Approximately 5.8 million people in the U.S. are afflicted by Alzheimer’s dementia. Many patients diagnosed with the disease will experience agitation, which is characterized by verbal and physical aggression, excessive motor activity, restlessness, and wandering. Agitation is the principle reason why patients move from home-based care to supervised living, to residential care and then to nursing homes, as they exceed the capacity of their care setting to manage agitation. Each transition being of escalating financial burden, predicting agitation would enable patients to be managed in the least restrictive lowest cost setting, potentially delaying the necessity to transition care. There are no predictive technologies for agitation and FDA approved treatments to help the agitation associated with Alzheimer’s disease or other forms of dementia.

“BioXcel Therapeutics is very pleased to further develop the BXCL501 program with integrated preventive treatment approaches,” said Frank Yocca, Chief Scientific Officer of BioXcel Therapeutics. “Our goal is to both prevent and reduce agitation episodes by proactively and safely administering BXCL501. We are excited to partner our 501 program with predictive technologies to develop non-invasive solutions that are designed to be easy to administer, well tolerated and provide rapid relief without excessive sedation.”

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