- All three patients enrolled in study have been cured, confirming high cure rate of tafenoquine in immunosuppressed patients, as reported by Yale in a 2024 publication
- Company calls for existing babesiosis treatment guidelines to be reviewed in light of the new data
WASHINGTON, March 11, 2026 (GLOBE NEWSWIRE) -- 60 Degrees Pharmaceuticals, Inc. (NASDAQ: SXTP; SXTPW) ("60 Degrees" or the "Company"), a pharmaceutical company focused on developing new medicines for vector-borne disease, today announced that three of three enrolled patients have been cured of babesiosis after completing the tafenoquine regimen in the Company's trial of relapsing babesiosis in immunosuppressed patients.
The Company's expanded use trial is an open-label, expanded access, multi-site study evaluating the safety and efficacy of the ARAKODA regimen of tafenoquine combined with atovaquone and other antimalarials/antibiotics administered to patients with risk factors for severe disease with relapsing babesiosis who have previously failed conventional antimicrobial regimens (NCT06478641). It aims to confirm the high cure rate from the addition of tafenoquine in these patients, as reported by the Yale School of Public Health in a 2024 Clinical Infectious Diseases publication.
For this study, tafenoquine treatment is continued for up to one year until two consecutive negative PCR tests for Babesia parasites are recorded and symptoms of babesiosis are resolved. Sixty to ninety days following clinical resolution and cessation of study drug administration, the study protocol calls for a follow-up visit at which two molecular tests are administered to assess parasite infection status. One test is an RT-PCR from Mayo Clinic. The second is a U.S. Food and Drug Administration (FDA)-approved RNA amplification test used for blood donation screening that is at least 1,000 times more sensitive than standard commercial RT-PCRs such as the Mayo test. A patient is considered cured if no evidence of infection (i.e., a non-reactive RNA amplification test) is detected following treatment.
The Yale study reported an apparent treatment success rate of 100 percent in four patients when an atovaquone-containing standard of care regimen was combined with weekly tafenoquine administered until two sequential non-reactive conventional PCRs were noted. The fifth patient in the Yale study was administered weekly tafenoquine monotherapy, then azithromycin/atovaquone; the triple regimen was not sustained until consecutive negative PCRs were noted, and so was not successful.
That same final patient in the Yale study was the third patient in the Company's expanded access study, and a quadruple combination of atovaquone/azithromycin/proguanil and weekly tafenoquine sustained until two negative PCRs were noted was ultimately curative as demonstrated through a non-reactive RNA amplification test following treatment. Cure was achieved with a triple combination of tafenoquine, atovaquone, and an antibiotic for the first two patients enrolled in the study.
Collectively, in the seven patients evaluated (the Yale study and the Company's study, combined), the data suggest that the cure rate for relapsing babesiosis in immunosuppressed patients approaches 100 percent when weekly tafenoquine is added to a patient's background atovaquone-containing combination regimen and sustained until two negative PCRs are noted.
Given the rarity of relapsing immunosuppressed patients and the high cure rate associated with adding tafenoquine, the Company believes it is an appropriate time for widely accepted treatment guidelines to be reviewed in light of the new data.
Human babesiosis is a serious and debilitating emerging tick-borne illness often found as a co-infection in patients with Lyme disease. Symptoms include fevers, chills, sweats, and fatigue. Babesiosis can be life-threatening in elderly and immunosuppressed patients, relapsing multiple times. Incidence of the disease is rising.
No FDA-approved treatment or vaccine exists for babesiosis.
Tafenoquine is not currently approved by the FDA for the treatment and prevention of babesiosis. Tafenoquine is approved for malaria prophylaxis in the United States under the product name ARAKODA (tafenoquine).
About ARAKODA (tafenoquine)
Tafenoquine was discovered by Walter Reed Army Institute of Research. Tafenoquine was approved for malaria prophylaxis in 2018 in the United States as ARAKODA and in Australia as KODATEF. Both were commercially launched in 2019 and are currently distributed through pharmaceutical wholesaler networks in each respective country. They are available at retail pharmacies as a prescription-only malaria prevention drug. According to the Centers for Disease Control and Prevention, the long terminal half-life of tafenoquine, which is approximately 16 days, offers the advantage of less frequent dosing for the prophylaxis of malaria. ARAKODA is not suitable for everyone, and patients and prescribers should review the Important Safety Information below. Individuals at risk of contracting malaria are prescribed ARAKODA 2 x 100 mg tablets once per day for three days (the loading phase) prior to travel to an area of the world where malaria is endemic, 2 x 100 mg tablets weekly for up to six months during travel, then 2 x 100 mg in the week following travel.
ARAKODA- (tafenoquine) Important Safety Information
ARAKODA is an antimalarial indicated for the prophylaxis of malaria in patients aged 18 years and older.
Contraindications
ARAKODA should not be administered to:
- Glucose-6-phosphate dehydrogenase ("G6PD") deficiency or unknown G6PD status;
- Breastfeeding by a lactating woman when the infant is found to be G6PD deficient or if
- G6PD status is unknown;
- Patients with a history of psychotic disorders or current psychotic symptoms; or
- Known hypersensitivity reactions to tafenoquine, other 8-aminoquinolines, or any component of ARAKODA-
Warnings and Precautions
Hemolytic Anemia: G6PD testing must be performed before prescribing ARAKODA due to the risk of hemolytic anemia. Monitor patients for signs or symptoms of hemolysis.
G6PD Deficiency in Pregnancy or Lactation: ARAKODA may cause fetal harm when administered to a pregnant woman with a G6PD-deficient fetus. ARAKODA is not recommended during pregnancy. A G6PD-deficient infant may be at risk for hemolytic anemia from exposure to ARAKODA through breast milk. Check infant's G6PD status before breastfeeding begins.
Methemoglobinemia: Asymptomatic elevations in blood methemoglobin have been observed. Initiate appropriate therapy if signs or symptoms of methemoglobinemia occur.
Psychiatric Effects: Serious psychotic adverse reactions have been observed in patients with a history of psychosis or schizophrenia, at doses different from the approved dose. If psychotic symptoms (hallucinations, delusions, or grossly disorganized thinking or behavior) occur, consider discontinuation of ARAKODA therapy and evaluation by a mental health professional as soon as possible.
Hypersensitivity Reactions: Serious hypersensitivity reactions have been observed with administration of ARAKODA. If hypersensitivity reactions occur, institute appropriate therapy.
Delayed Adverse Reactions: Due to the long half-life of ARAKODA (approximately 16 days), psychiatric effects, hemolytic anemia, methemoglobinemia, and hypersensitivity reactions may be delayed in onset and/or duration.
Adverse Reactions: The most common adverse reactions (incidence greater than or equal to 1 percent) were: headache, dizziness, back pain, diarrhea, nausea, vomiting, increased alanine aminotransferase (ALT), motion sickness, insomnia, depression, abnormal dreams, and anxiety.
Drug Interactions
Avoid co-administration with drugs that are substrates of organic cation transporter-2 or multidrug and toxin extrusion transporters.
Use in Specific Populations
Lactation: Advise women not to breastfeed a G6PD-deficient infant or infant with unknown G6PD status during treatment and for 3 months after the last dose of ARAKODA. To report SUSPECTED ADVERSE REACTIONS, contact 60 Degrees Pharmaceuticals, Inc. at 1- 888-834-0225 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. The full prescribing information of ARAKODAis located here
About 60 Degrees Pharmaceuticals, Inc.
60 Degrees Pharmaceuticals, Inc., founded in 2010, specializes in developing and commercializing new medicines for the treatment and prevention of vector-borne disease. The Company achieved U.S. Food and Drug Administration approval of its lead product, ARAKODA (tafenoquine), for malaria prevention, in 2018. ARAKODA is commercially available in the U.S. and Australia. 60 Degrees Pharmaceuticals, Inc. also collaborates with prominent research and academic organizations in the U.S. and Australia. 60 Degrees Pharmaceuticals, Inc. is headquartered in Washington, D.C., with a subsidiary in Australia. Learn more at www.60degreespharma.com
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Media Contacts:
Sheila A. Burke
SheilaBurke-consultant@60degreespharma.com
(484) 667-6330
Investor Contact
Patrick Gaynes
patrickgaynes@60degreespharma.com
