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WASHINGTON - 60 Degrees Pharmaceuticals, Inc. (NASDAQ:SXTP), trading near $1.30 and down over 80% in the past year according to InvestingPro data, announced Tuesday it has signed a clinical trial agreement with the Icahn School of Medicine at Mount Sinai in New York City to conduct a Phase II study of tafenoquine in treating chronic babesiosis.
The open-label study will evaluate the efficacy and safety of ARAKODA (tafenoquine) over a 90-day period in patients with chronic babesiosis, defined as those experiencing disabling fatigue for at least six months with laboratory confirmation of the tick-borne illness.
The trial’s primary endpoint will measure changes in general fatigue using a patient-reported outcome measure. Enrollment is expected to begin in Q4 2025 and be completed by Q2 2026.
Patients will take tafenoquine orally for the first four days, then weekly for the remainder of the 12-week treatment period.
"They bring deep expertise and skill in researching tick-borne illnesses," said Geoff Dow, CEO of 60 Degrees Pharmaceuticals, regarding the Mount Sinai research team.
This study is one of three clinical trials sponsored by the company to evaluate tafenoquine’s potential for treating babesiosis. Data from these studies, expected in the first half of 2026, will support a planned New Drug Application to the FDA. The company’s financial position shows a current ratio of 2.27, indicating sufficient liquidity to fund near-term operations, though InvestingPro analysis reveals the company is quickly burning through cash.
Babesiosis is caused by Babesia parasites that multiply in red blood cells, causing symptoms including fevers, chills, sweats, and fatigue. The disease, transmitted by the same tick that spreads Lyme disease, can be life-threatening in elderly and immunosuppressed patients.
Currently, there is no FDA-approved treatment for chronic babesiosis. Tafenoquine is currently approved only for malaria prophylaxis in the United States under the brand name ARAKODA.
According to the press release statement, the company is focused on developing new medicines for vector-borne diseases. Despite challenging market conditions, analysts anticipate sales growth for the current year, with revenue already showing a 128.7% increase in the last twelve months. InvestingPro subscribers can access 12 additional key insights about SXTP’s financial health and growth prospects.
In other recent news, 60 Degrees Pharmaceuticals has successfully closed a public offering that generated $5 million in gross proceeds. This offering involved the sale of 2,631,578 shares of common stock, along with Series A-1 and Series A-2 warrants. Additionally, the company has entered into a research agreement with Tulane University to study the effectiveness of tafenoquine against Lyme disease and Bartonella bacteria. In a bid to expand its market presence, 60 Degrees Pharmaceuticals has identified a $245 million market potential for its drug ARAKODA, targeting human babesiosis treatment. The company estimates a total addressable market of 1.17 million patients by 2035. Moreover, the company is planning to seek FDA’s Minor Use Minor Species designation for tafenoquine in treating acute canine babesiosis. This move follows analysis of clinical efficacy studies and existing safety data. Lastly, 60 Degrees Pharmaceuticals has introduced new packaging for its malaria drug ARAKODA, now available in an 8-count bottle at major retail pharmacies, including Amazon Pharmacy, aimed at travelers needing short-term prophylactic therapy.
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