CHATHAM, N.J. - Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) has initiated a Phase 2 trial for TNX-1300, a potential treatment for acute cocaine intoxication, with the first patient dosed in a study taking place in emergency departments across six U.S. academic medical centers. The trial assesses the safety and efficacy of a single 200 mg dose of TNX-1300 compared to placebo, alongside standard care, for individuals presenting with symptoms of cocaine intoxication.
TNX-1300 is a recombinant enzyme designed to degrade and metabolize cocaine rapidly, potentially offering a targeted approach to treating the life-threatening effects of cocaine overdose. Cocaine intoxication can lead to severe health issues, including hyperthermia, arrhythmias, and seizures. In 2022, cocaine overdose resulted in 27,569 deaths in the U.S., highlighting the urgent need for effective treatments.
The study is a single-blind, randomized trial involving approximately 60 subjects. It aims to measure the reduction of systolic blood pressure as its primary endpoint, with additional secondary endpoints including the reduction of cocaine levels and its metabolites in the blood. The topline results from the trial are anticipated in the first half of 2025.
Tonix Pharmaceuticals has previously received a Cooperative Agreement Grant from the National Institute on Drug Abuse (NIDA) to support the development of TNX-1300. The FDA has also granted the drug Breakthrough Therapy designation, underscoring the critical need for new treatments in this area.
The trial comes at a time when cocaine abuse remains a significant public health challenge in the U.S. With no FDA-approved treatment currently available for cocaine intoxication, TNX-1300 could potentially fill a substantial gap in emergency care protocols.
This Phase 2 trial represents a step forward in addressing the morbidity and mortality associated with cocaine use, which continues to be a major problem in the United States. The information for this report is based on a press release statement from Tonix Pharmaceuticals Holding Corp.
In other recent news, amid rising concerns about an mpox outbreak, vaccine and drug developers GeoVax Labs and Tonix Pharmaceuticals have seen a sharp increase in premarket trading. Emergent BioSolutions, another player in the sector, also experienced a rise in its share value. The World Health Organization declared mpox a global public health emergency following the rapid spread of a new variant of the virus in Africa. Meanwhile, Bavarian Nordic, a Danish company that produces an mpox vaccine, saw its shares fall despite a previous jump amid escalating virus concerns. Siga Technologies' shares edged up slightly after its mpox drug did not meet the main goal in a clinical study.
Tonix Pharmaceuticals has confirmed its commitment to expedite the development of its TNX-801 vaccine candidate in the wake of the WHO's declaration. The U.S. National Institutes of Health (NIH) has selected Tonix's vaccine platform for Project NextGen. In addition, Tonix Pharmaceuticals has reported significant progress in several areas, including the development of its investigational drug, TNX-102 SL, for managing fibromyalgia. The company has also entered into a sales agreement with A.G.P./Alliance Global Partners (NYSE:GLP), allowing the sale of up to $50 million of its common stock over time.
In the financial sphere, Tonix has announced a public offering of approximately 7.1 million shares, which is expected to raise $4 million before deducting fees and expenses. Regarding analyst notes, Noble Capital has maintained an Outperform rating on the stock, but lowered the target to $1.50 from the previous $10.00. These are the recent developments at Tonix Pharmaceuticals.
InvestingPro Insights
As Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) embarks on their Phase 2 trial for TNX-1300, investors and stakeholders are closely monitoring the company's financial health and stock performance. According to recent data from InvestingPro, Tonix Pharmaceuticals has a market capitalization of 9.42 million USD, which reflects the company's current valuation in the eyes of investors.
The company's financials show a gross profit of 2.69 million USD over the last twelve months as of Q2 2024, with a gross profit margin of 21.59%. However, the operating income has been significantly negative, standing at -95.19 million USD during the same period, indicating challenges in managing operational costs relative to revenues.
InvestingPro Tips suggest that Tonix Pharmaceuticals is quickly burning through cash and has not been profitable over the last twelve months. Moreover, the stock has experienced high price volatility and has taken a substantial hit over the last week. These factors may be of interest to potential investors considering the risks associated with the biopharmaceutical sector, particularly for a company in the midst of critical clinical trials.
For those seeking more in-depth analysis, there are additional InvestingPro Tips available at https://www.investing.com/pro/TNXP, which provide further insights into the company's stock performance and financial health.
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