Type C meeting will be to discuss a proposed Phase II study of tafenoquine for treatment of babesiosis
Transmitted by ticks, babesiosis is a life-threatening parasitic disease increasing in frequency in the United States
Meeting with FDA scheduled for January 15, 2024
WASHINGTON, Nov. 15, 2023 (GLOBE NEWSWIRE) -- 60 Degrees Pharmaceuticals, Inc.(NASDAQ: SXTP; SXTPW) (“60P” or the “Company”), a pharmaceutical company focused on developing new medicines for infectious diseases, announced today that the U.S. Food and Drug Administration (FDA) has granted a Type C meeting with the Company to consult on the path forward in developing the tafenoquine regimen of ARAKODA® for a potential indication in treating hospitalized babesiosis patients. The meeting will take place on January 15, 2024.
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 has not been proven to be effective for treatment or prevention of babesiosis and is not approved by the FDA for such an indication.
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 practice of medicine. The Company is planning an adequate and well controlled clinical study to evaluate this use systematically.
About Babesiosis
An estimated 47,000 cases of babesiosis (infections caused by red blood cell parasites similar to malaria that are transmitted by deer tick bites) occur in the United States each year and the incidence rate is increasing.1 An estimated 10 percent of Lyme disease patients are co-infected with babesiosis.2 The mortality rate of babesiosis patients with cardiac complications approaches 10 percent.3
Anyone can get babesiosis, but it can be more severe in the elderly, people who have had their spleen removed, and in people who have weakened immune systems (for example, those who have cancer, HIV/AIDS, or a transplant). Most cases occur in coastal areas in the Northeast and upper Midwest, particularly in parts of New England, New York State, New Jersey, Wisconsin, Minnesota and in some European countries. In the Northeast, babesiosis occurs in both inland and coastal areas including offshore islands, such as Nantucket and Martha's Vineyard, which are off Massachusetts, as well as Long Island and the Hudson Valley in New York State.
Hospitalizations as a result of babesiosis are usually seasonal, occurring June through August. Clinical complications include severe anemia, renal failure, cardiorespiratory failure, and death.
Babesiosis is spread by the bite of an infected blacklegged tick, Ixodes scapularis. It can also be spread by transfusion of contaminated blood.
Babesiosis was designated a nationally notifiable disease in the United States in 2011, meaning that states where it was reportable were charged to voluntarily notify the Centers for Disease Control and Prevention of cases.
About ARAKODA® (tafenoquine)
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.
Delayed Adverse Reactions: Due to the long half-life of ARAKODA® (approximately 17 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 (OCT2) or multidrug and toxin extrusion (MATE) 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 ARAKODA® is located here.
About 60 Degrees Pharmaceuticals, Inc.
60 Degrees Pharmaceuticals, Inc., founded in 2010, specializes in developing and marketing new medicines for the treatment and prevention of infectious diseases that affect the lives of millions of people. 60P successfully achieved FDA approval of its lead product, ARAKODA® (tafenoquine), for malaria prevention, in 2018. 60P also collaborates with prominent research organizations in the U.S., Australia, and Singapore. 60P’s mission has been supported through in-kind funding from the U.S. Department of Defense and private institutional investors including Knight Therapeutics Inc., a Canadian-based pan-American specialty pharmaceutical company. 60P is headquartered in Washington D.C., with a majority-owned subsidiary in Australia. Learn more at www.60degreespharma.com.
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