Full Press Release Details
60 Degrees Pharmaceuticals Receives
FDA Orphan Drug Designation for Tafenoquine for Treatment of Patients with Acute Babesiosis
WASHINGTON, June 11, 2024 (GLOBE NEWSWIRE)
-- 60 Degrees Pharmaceuticals, Inc. (NASDAQ: SXTP; SXTPW) (the "Company" or "60 Degrees Pharmaceuticals"), a
pharmaceutical company focused on developing new medicines for infectious diseases, announced today that the U.S. Food and Drug Administration
("FDA") has granted its investigational tafenoquine candidate orphan drug designation for the treatment of patients
with acute babesiosis.
FDA orphan drug designation is granted
for therapeutic candidates that may prevent or treat a rare disease or condition, such as acute babesiosis. Babesiosis is a steadily
emerging, infectious disease transmitted by a microscopic parasite, Babesia, through the bite of the black-legged (deer) tick,
the vector that spreads Lyme disease. Babesiosis may be life-threatening in elderly and immunosuppressed patients. Up to 10 percent of
Lyme disease patients may be coinfected with Babesia. Therefore, up to 47,600 of the estimated 476,000 patients with new Lyme infections
each year may be co-infected with Babesia.
"Results of recent animal studies
of tafenoquine show exciting promise for the drug to have potential in human patients with acute babesiosis," said Chief
Executive Officer of 60 Degrees Pharmaceuticals, Geoff Dow, PhD. "The FDA granting tafenoquine orphan drug designation for
acute babesiosis validates the growing need for an additional therapeutic option that infectious disease specialists can use in addressing
this very serious, potentially life-threatening illness. We look forward to results of our clinical trial program in coming months and
to the prospect of securing a secondary indication for tafenoquine in the area of acute babesiosis treatment."
60 Degrees Pharmaceuticals
recently announced it has entered into an agreement with Tufts Medical Center in Boston to
conduct the world's first clinical trial evaluating the efficacy and safety of tafenoquine in
treating patients who have acute babesiosis. Recruitment for the trial will begin on June 13, 2024, and will include at least
24 patients hospitalized with babesiosis. Additional recruitment sites at prominent university hospitals in the Northeast U.S. are also
With the tafenoquine for acute babesiosis
orphan drug designation, 60 Degrees Pharmaceuticals now qualifies for certain incentives, including market exclusivity, tax credits,
and exemption from certain FDA filing fees.
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 U.S. Food and Drug Administration for
About the Study of Tafenoquine for Patients
Hospitalized with Babesiosis
The study is a randomized, double-blind,
placebo-controlled trial that will enroll patients at multiple sites in the Northeast U.S. and will compare the safety and
efficacy of tafenoquine versus placebo in patients hospitalized for babesiosis with low risk for relapsing disease who will also
be administered a standard-of-care antimicrobial regimen. The two main study endpoints will be the time to sustained clinical resolution
of symptoms and the time to molecular cure as determined by an FDA-approved nucleic acid test. At least 24, and as many as 33 patients,
will be recruited before an interim analysis is conducted. Sufficient enrollment capacity is planned to allow all study subjects to be
recruited during the 2024 tick season (June to September) if caseload is high. The interim analysis will include both a test of significance,
as well as size re-estimation to allow additional recruitment if required. The study will be conducted at three hospitals in the Northeast
U.S. The efficacy and safety of 8-aminoquinolines, a class of drugs that includes tafenoquine and primaquine, for
prevention and treatment of malaria is well documented. Several case reports of tafenoquine use for babesiosis indicate
that the drug is already being used for this purpose in the practice of medicine in the U.S.
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, 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.
ARAKODA should not be administered to:
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
Avoid co-administration with drugs that are substrates of organic cation transporter-2 or multidrug and toxin extrusion transporters.
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,
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 at www.60degreespharma.com.
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