WASHINGTON - 60 Degrees Pharmaceuticals, Inc. (NASDAQ: SXTP; SXTPW), a biopharmaceutical company specializing in infectious diseases, has initiated patient enrollment for a clinical trial at Yale University, Rhode Island Hospital, and Tufts Medical Center to evaluate the efficacy and safety of tafenoquine in treating babesiosis, an emerging tick-borne disease.
The study is the first of its kind—a randomized, double-blind, placebo-controlled trial—and is expected to provide interim results by September 2025.
Babesiosis is caused by the Babesia parasite, transmitted through the bite of infected ticks, particularly in the Northeast U.S., where cases are on the rise. The disease can be life-threatening, especially in the elderly and those with compromised immune systems. Current treatments are limited, particularly for patients with relapsing babesiosis, for whom previous therapies have failed.
The clinical trial will enroll at least 24 hospitalized patients diagnosed with relapsing babesiosis, with the potential to increase to 33 participants. The primary endpoints will be the time to sustained clinical resolution of symptoms and the time to molecular cure, verified by an FDA-approved nucleic acid test.
Dr. Geoff Dow, CEO of 60 Degrees Pharmaceuticals, emphasized the importance of the trial, noting the high cure rate observed in case studies where tafenoquine was combined with standard-of-care treatments for immunosuppressed patients with relapsing babesiosis.
Tafenoquine, marketed as ARAKODA®, is already approved for malaria prophylaxis in the United States and Australia. However, it has not yet been approved by the U.S. Food and Drug Administration (FDA) for the treatment or prevention of babesiosis. The drug's long half-life, around 16 days, may offer advantages in dosing frequency.
The accessible market for ARAKODA® for babesiosis treatment is estimated to be around 400,000 patients in the U.S. through the end of its patent protection in December 2035.
60 Degrees Pharmaceuticals was founded in 2010 and has previously achieved FDA approval for ARAKODA® for malaria prevention. The company collaborates with various research organizations globally and has received support from the U.S. Department of Defense and private investors.
The information provided in this article is based on a press release statement from 60 Degrees Pharmaceuticals.
In other recent news, 60 Degrees Pharmaceuticals has made significant strides in its operations and research. The company's shareholders recently approved key proposals, including the election of five board members and amendments to the equity incentive plan and certificate of incorporation. They also approved modifications to the strike price of options granted to the CEO and CFO, ensuring compliance with Nasdaq Listing Rule 5635(c).
A recent financial report showed 60 Degrees Pharmaceuticals surpassing expectations with a gross profit of $81,000 for the first quarter, as reported by Ascendiant Capital. Despite higher-than-anticipated operating expenses totaling $1.8 million, non-operating items offset the increase, resulting in a net profit of $309,000. Ascendiant Capital maintains its Buy rating on the company, adjusting future earnings estimates based on these results.
These are recent developments in the company's ongoing efforts to develop new treatments for infectious diseases.
InvestingPro Insights
As 60 Degrees Pharmaceuticals, Inc. (NASDAQ: SXTP; SXTPW) embarks on its pioneering clinical trial for babesiosis treatment, it's important for investors to look beyond the press release and examine the company's financial health and market performance. According to InvestingPro data, the company has a revenue growth of 2.63% for the last twelve months as of Q1 2024, which is a positive sign, but it's also important to note that the company has a negative gross profit margin of -262.72% for the same period, indicating that the cost of goods sold exceeds the revenue generated from those goods.
Investors should be aware that the company's stock price has experienced a significant decline over the past year, with a -92.55% one-year price total return as of the beginning of 2024. This could be a point of concern for potential investors, although it might also be seen as a potential entry point for those who believe in the company's long-term prospects. Additionally, the revenue growth (quarterly) as of Q1 2024 is 580.65%, suggesting a recent surge that could be tied to optimistic market expectations or other factors.
Among the InvestingPro Tips, it's worth highlighting that analysts do not anticipate the company will be profitable this year, and the valuation implies a poor free cash flow yield. This could be particularly relevant for investors who prioritize profitability and cash flow in their investment decisions. On a more positive note, the company holds more cash than debt on its balance sheet, which could provide some financial stability and flexibility.
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The ongoing clinical trial and the potential FDA approval for ARAKODA® for babesiosis treatment could be a turning point for 60 Degrees Pharmaceuticals. With the accessible market for the treatment estimated to be around 400,000 patients in the U.S., the company's future prospects could be significant if the trial results are positive and if the company can navigate its financial challenges effectively.
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