60 Degrees Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has provided comments on the protocol of a planned clinical trial that will study the use of tafenoquine in treating babesiosis. Babesiosis, a potentially life-threatening disease in immunosuppressed patients, is a tick-borne illness steadily emerging in the United States. The FDA had some questions and recommendations that will be addressed.

Nothing in the comments requires the Company to change the trial design/protocol in a material way. The Company is continuing preparatory actions to facilitate initiation of patient enrollment later in 2024. The Company conducted a Type C regulatory meeting with the FDA on January 17, 2024, at which a synopsis of the current version of the tafenoquine for babesiosis study protocol was discussed.

In February 2024, the Company submitted a full protocol to the FDA under its malaria Investigational New Drug (?IND?) application, incorporating FDA feedback from the January 17, 2024 meeting. Because the protocol was submitted under an existing (rather than a new) IND application per the FDA?s advice, no formal statutory response time was required by the FDA. The FDA informed the Company in March 2024, however, that comments on that protocol would be provided by April 30, 2024.

The FDA provided this feedback on April 26, 2024. This study is a randomized double-blind placebo-controlled trial anticipated to enroll at least 24 patients in the U.S. in 2024. The two main study endpoints will be time to sustained clinical resolution of symptoms of babesiosis and molecular cure as determined by an FDA-approved nucleic acid test.

The study will be conducted at three hospitals in the northeastern United States. The efficacy and safety of 8-aminoquinolines, a class of drugs that includes tafenoquine and primaquine, for prevention and treatment of malaria is well established. The appearance of several case studies of tafenoquine use for babesiosis in the literature suggests that the drug is being used for this purpose in the practice of medicine in the U.S. 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, may offer potential advantages in less-frequent dosing for prophylaxis for 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. 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, motion sickness, insomnia, depression, abnormal dreams and anxiety. Drug InteractionsAvoid co-administration with drugs that are substrates of organic cation transporter-2 (OCT2) 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.