BioXcel Therapeutics begins Phase 3 trial for agitation treatment

BioXcel Therapeutics, Inc., a pharmaceutical company specializing in the development of drugs for neurological disorders and cancer, has announced the commencement of patient enrollment in its SERENITY At-Home pivotal Phase 3 trial on Thursday.

The study is designed to evaluate the safety of BXCL501, the company's investigational, orally dissolving film formulation of dexmedetomidine, for the acute treatment of agitation associated with bipolar disorders or schizophrenia in a home setting.

The double-blind, placebo-controlled trial aims to enroll approximately 200 patients who will self-administer a 120 mcg dose of BXCL501 or a placebo when experiencing agitation episodes. Over a 12-week period, patients, either living alone or with caregivers, will participate in the study. The safety data will be collected from subjects and caregivers through telephone interviews, in-clinic visits, and agitation episode diaries.

While the primary focus of the trial is safety, an exploratory endpoint will include a modified clinical global impression of change (mCGI-C) to be completed two hours after dosing. This will provide an evaluation of the treatment's effectiveness in the outpatient setting from the patients' or caregivers' perspective.

BioXcel Therapeutics has outlined that the trial duration is expected to be between 9 to 12 months. The initiation of this Phase 3 trial marks a significant milestone for the company as it progresses towards potentially offering a new treatment option for those suffering from agitation related to bipolar disorders or schizophrenia.

This report is based on a press release statement and the company's recent SEC filing.

In other recent news, BioXcel Therapeutics has made significant strides in its operations. The company reported a top-line revenue of $1.1 million for the second quarter, primarily due to sales of IGALMI, its approved treatment for agitation in patients with schizophrenia or bipolar disorder. This figure surpassed the forecasted $0.8 million.

The company is also preparing to initiate a Phase 3 trial for the at-home use of BXCL501, referred to as the SERENITY At-Home trial, and is finalizing its protocol for the TRANQUILITY In-care pivotal Phase 3 program in Alzheimer's patients.

BioXcel recently revised its commercial supply agreement with ARx, modifying the minimum annual payment obligations for the next three years. This move could potentially alleviate some of BioXcel Therapeutics' financial commitments in the near term and align future payments more closely with the company's regulatory success.

Furthermore, the company has made amendments to its corporate structure, increasing the number of authorized shares from 100 million to 200 million.

On the analyst front, Canaccord Genuity maintained a Buy rating and a $7.00 price target for BioXcel, while Mizuho Securities revised its 12-month price target for the company from $4.00 to $1.00, maintaining a neutral rating. Simultaneously, H.C. Wainwright also adjusted its outlook for BioXcel, reducing the price target to $7.00 but maintaining a buy rating.

These are the recent developments in BioXcel Therapeutics' operations and analyst ratings, reflecting the company's strategic direction and active governance. The company is advancing its late-stage clinical programs for BXCL501 treatment, with plans to file a supplemental New Drug Application (sNDA) in 2025. BioXcel Therapeutics is also exploring financing options and potential partnerships for future growth while continuously evaluating operating expenses for optimization.

InvestingPro Insights

As BioXcel Therapeutics forges ahead with its Phase 3 trial for BXCL501, a closer look at the company's financial health and market performance could provide investors with a clearer picture. According to InvestingPro data, BioXcel Therapeutics currently holds a market capitalization of $24.45 million.

Despite the challenges, analysts have revised their earnings upwards for the upcoming period, reflecting optimism about the company's potential growth. Moreover, while the company is quickly burning through cash, it is noteworthy that its liquid assets exceed short-term obligations, indicating a degree of financial flexibility in the near term.

InvestingPro Tips suggest that BioXcel operates under a significant debt burden, and analysts do not anticipate the company will be profitable this year. These factors are crucial for investors to consider, especially when evaluating the company's long-term sustainability and its ability to fund ongoing clinical trials. For those interested in a deeper dive into BioXcel's financials and performance metrics, there are 15 additional InvestingPro Tips available at https://www.investing.com/pro/BTAI, which could further inform investment decisions.

While the company's stock has fared poorly over the last month, reflecting a broader market trend, the real-time data points to a substantial revenue growth of 131.5% over the last twelve months as of Q1 2023. This suggests that despite current challenges, BioXcel Therapeutics is experiencing significant growth in its revenue streams, which could be a positive indicator for the company's future, particularly if the SERENITY At-Home trial demonstrates favorable outcomes.

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