WASHINGTON - 60 Degrees Pharmaceuticals, Inc. (NASDAQ: SXTP, SXTPW), a company specializing in the development of medications for infectious diseases, has disclosed that the U.S. Food and Drug Administration (FDA) will provide comments on its babesiosis trial protocol in April 2024.
The company had previously expected feedback in March 2024. Despite the delay, 60 Degrees Pharmaceuticals is moving forward with plans to commence the trial on June 1, 2024.
The trial involves tafenoquine, an active ingredient in the FDA-approved anti-malarial drug ARAKODA®, which has been available for malaria prophylaxis since its launch in 2019 in the United States and Australia. The drug is designed for use in adults 18 years and older and is distributed through pharmaceutical wholesalers and available by prescription at retail pharmacies.
The Centers for Disease Control and Prevention notes that tafenoquine's long terminal half-life, approximately 16 days, could offer advantages in dosing frequency for malaria prophylaxis.
However, ARAKODA® is not suitable for everyone due to potential risks, including hemolytic anemia in individuals with Glucose-6-phosphate dehydrogenase (G6PD) deficiency, a heightened risk of hemolytic anemia in G6PD-deficient fetuses or infants through breastfeeding, and possible psychiatric effects.
The most common adverse reactions reported were headaches, dizziness, and back pain, among others. The drug's long half-life means that side effects like psychiatric effects, hemolytic anemia, and hypersensitivity reactions may be delayed in onset and duration.
60 Degrees Pharmaceuticals, founded in 2010, has a history of collaboration with research organizations in the U.S., Australia, and Singapore. The company's mission has been supported by the U.S. Department of Defense and private investors, including Knight Therapeutics Inc.
This announcement is based on a press release statement and comes amid the company's ongoing efforts to expand its product offerings beyond malaria prevention.
As with all clinical trials and new pharmaceutical developments, the process is subject to regulatory review and approval, and the outcomes are not guaranteed. Investors and interested parties are advised to monitor further communications from 60 Degrees Pharmaceuticals and the FDA for updates on the progress of the trial and any potential impacts on the company's portfolio.
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