BioXcel Therapeutics provided an update on its late-stage clinical trials for BXCL501, a drug for acute agitation, and highlighted recent corporate developments. The company is advancing the SERENITY at-home trial for agitation related to bipolar disorders or schizophrenia and planning the TRANQUILITY in-care trial for agitation in Alzheimer’s dementia. BioXcel also improved its financial position through a credit amendment and equity funding, and strengthened its leadership with new board appointments.
The progress of these clinical trials is crucial as acute agitation represents a significant unmet need for millions of individuals affected by bipolar disorders, schizophrenia, and Alzheimer’s dementia. Effective treatments are limited, and BXCL501 offers a potential new approach to rapidly manage these episodes, especially in the at-home setting, which is a significant development for patient care. Additionally, the focus on Alzheimer’s dementia addresses a growing patient population with specific agitation challenges.
The SERENITY trial is actively enrolling patients, and the TRANQUILITY trial design is finalized. While continuing to supply its currently approved drug, IGALMI, BioXcel secured $7 million in equity funding and amended its existing credit agreement to improve financial stability. Two key appointments to the Board of Directors bring extensive clinical, financial, and legal expertise, further bolstering the company’s strategic direction.
These developments collectively position BioXcel to potentially address a significant market need with BXCL501 while ensuring operational and financial stability. The ongoing clinical trials, coupled with enhanced leadership and financial flexibility, suggest a strong focus on bringing this potential treatment to market, which could significantly impact the landscape of agitation management in various neuropsychiatric disorders.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
