NEW HAVEN, Conn. - BioXcel Therapeutics, Inc. (NASDAQ: BTAI), a biopharmaceutical company leveraging artificial intelligence in drug development, has announced plans to initiate a pivotal Phase 3 trial for the at-home treatment of agitation associated with bipolar disorders or schizophrenia. The trial will assess the safety and efficacy of BXCL501, the company's investigational, orally dissolving film formulation of dexmedetomidine, at a 120 mcg dose.
The decision to proceed with the SERENITY At-Home Phase 3 trial follows a recent meeting with the U.S. Food and Drug Administration (FDA) and is based on the positive feedback received. The trial is designed as a double-blind, placebo-controlled study over a 12-week period and aims to enroll approximately 200 patients.
BXCL501 is already FDA-approved under the name IGALMI™ at the 120 mcg dose for acute treatment of agitation in adults with schizophrenia or bipolar I or II disorder, but only under healthcare provider supervision. The new trial seeks to expand its use to the home setting, where an estimated 60% of agitation episodes occur, according to Vincent O'Neill, M.D., Chief of Product Development and Medical Officer at BioXcel Therapeutics.
In addition to the main trial, the company plans to conduct a separate study involving around 30 patients to evaluate the correlation between patient-reported or informant-reported efficacy and trained rater-reported efficacy using the Positive and Negative Syndrome Scale-Excitatory Component (PEC) measurements.
The SERENITY At-Home trial represents a redesigned SERENITY III trial and is part of the company's broader effort to provide innovative treatments for neuropsychiatric disorders. BioXcel Therapeutics is also exploring BXCL501 for the acute treatment of agitation associated with dementia due to probable Alzheimer's disease.
This announcement is based on a press release statement and further information about the SERENITY program can be found on the company's website. The safety and efficacy of BXCL501 for at-home use remain to be established by the upcoming trial.
InvestingPro Insights
As BioXcel Therapeutics, Inc. (NASDAQ: BTAI) embarks on its pivotal Phase 3 trial for BXCL501, investors are closely monitoring the company's financials and market performance. According to InvestingPro data, BioXcel Therapeutics currently has a market capitalization of $101.84 million. Despite a significant revenue growth of 268% in the last twelve months as of Q4 2023, the company's gross profit margin stands at a low 8.7%, reflecting challenges in cost management.
Analysts are paying attention to the company's valuation metrics, which show a negative price-to-earnings (P/E) ratio of -0.58, indicating that the company is not currently profitable. This is further supported by an operating income margin of -12146.3%, suggesting substantial expenses relative to revenue. With the price of the stock at $2.55, it has seen a sharp decline of 87.59% from its 52-week high, which could indicate a potential undervaluation or investor concerns about the company's future profitability.
Investors seeking further insights can find additional InvestingPro Tips that shed light on BioXcel's financial health and future prospects. For instance, the company's quick cash burn rate and weak gross profit margins are critical factors to consider. Moreover, analysts do not expect BioXcel to turn a profit this year, and the stock is trading at a high revenue valuation multiple. On a more positive note, the company's liquid assets exceed its short-term obligations, which may provide some financial flexibility in the near term. There are 9 more InvestingPro Tips available, offering a comprehensive analysis for those considering an investment in BioXcel Therapeutics.
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