Full Press Release Details
60 Degrees Pharmaceuticals
Receives FDA Comments on Tafenoquine-Babesiosis
Clinical Trial Protocol; No Material Changes Required
WASHINGTON, D.C., May 2, 2024 -- 60 Degrees
Pharmaceuticals, Inc. (NASDAQ: SXTP; SXTPW) (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 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.
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.
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.
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.
About Babesiosis and the Tafenoquine Study
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.
There may be approximately 47,000 cases per
year in the U.S. based on the observation of 476,000 Lyme infections and an estimated babesiosis coinfection rate of 10 percent. The Company
estimates that more than a million U.S. citizens could benefit if approved prophylactic options become available.
About ARAKODA (tafenoquine)
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
ARAKODA is an antimalarial indicated
for the prophylaxis of malaria in patients aged 18 years of age and older.
ARAKODA should not be administered to:
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.
Avoid 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 .
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. 60 Degrees Pharmaceuticals, Inc. achieved FDA approval of its lead product, ARAKODA (tafenoquine),
for malaria prevention, in 2018. 60 Degrees Pharmaceuticals, Inc. also collaborates with prominent research organizations in the U.S.,
Australia, and Singapore. The 60 Degrees Pharmaceuticals, Inc. 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. 60 Degrees Pharmaceuticals, Inc. is headquartered in Washington D.C., with a majority-owned subsidiary in Australia. Learn more
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