Announcement • Jul 02
60 Degrees Pharmaceuticals Announces Positive Recommendation from Data Safety Monitoring Board for B-Free Phase 2 Study of Tafenoquine for Treatment of Chronic Babesiosis Patients with Severe Fatigue
60 Degrees Pharmaceuticals, Inc. announced that the independent Data Safety Monitoring Board has recommended continuation of the B-Free chronic babesiosis study (NCT06656351), following a review of safety data from the first six patients from baseline through Day 30. The B-Free study is evaluating recovery from fatigue following treatment with the ARAKODA regimen of tafenoquine (loading dose of 200 mg per day for four days, then 200 mg weekly through Day 90) in patients with severe persistent fatigue and laboratory evidence of exposure to Babesia spp. 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. B-FREE, an open-label study (NCT06656351), will evaluate the efficacy and safety of the ARAKODA (tafenoquine) regimen over 90 days in treating patients with a diagnosis of chronic babesiosis. The primary endpoint will be resolution of fatigue assessed using a patient-reported outcome measure (the multi-dimensional fatigue inventory general fatigue subscale) at Day 90 compared with baseline. Participants will have experienced significant functional impairment for at least six months. Tafenoquine (2 x 100 mg tablets) will be self-administered orally with food on Days 1, 2, 3, 4, then weekly thereafter for a total 12-week treatment period. Weekly treatment will start on Day 11 and end on Day 89. The study will enroll and treat up to 100 patients, with the goal being completion by at least 16 patients for whom Babesia infection was confirmed at baseline using validated molecular tests for Babesia. At baseline, and approximately monthly for six months, patients will be screened using the FDA-licensed RNA amplification test, and two CLIA-validated RT-PCR assays that are commercially available for patient care. Babesiosis is a tick-borne illness caused by Babesia parasites that develop and multiply in red blood cells. Its symptoms include fevers, chills, sweats, and fatigue, and in severe cases, can be life-threatening in elderly and immunosuppressed patients. Incidence of the disease is rapidly rising, particularly in the Northeast. Transmitted through the bite of the black-legged (deer) tick, the vector that spreads Lyme disease, babesiosis is an orphan disease. Insurance claims research commissioned by the Company suggests that the minimum annual incidence of babesiosis is at least 25,000 cases per year, although the true number may be much larger than this. Currently, no FDA-approved treatment exists specifically for babesiosis. Babesia infection persists for months, and potentially for several years following a tick bite. In patients with risk factors (e.g., immunosuppression, age, asplenia), persistent infection may result in recurring clinical relapses of the disease, each with the potential for hospitalization. In individuals without such known risk factors, it has been generally assumed that persistent infection is not clinically meaningful. However, the potential clinical significance of persistent infection in individuals with dysregulated immune systems (e.g., chronic tick-borne diseases, long COVID, and other long syndromes) has not been studied, but it is hypothesized to complicate recovery from other chronic symptoms – the prevalence of such disease has not been documented, but is potentially much larger than for acute illness as captured in medical claims data. Tafenoquine is approved for malaria prophylaxis in the United States under the product name ARAKODA. The safety of the approved regimen of tafenoquine for malaria prophylaxis has been assessed in five separate randomized, double-blind, active comparator or placebo-controlled trials for durations of up to six months. Tafenoquine was discovered by Walter Reed Army Institute of Research, and the current study was funded by the United States Army Medical & Materiel Development Activity. 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. ARAKODA (tafenoquine) Important Safety Information: ARAKODA is an antimalarial indicated for the prophylaxis of malaria in patients aged 18 years of age 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.
