Full Press Release Details
First Patient Enrolled in 60 Degrees Pharmaceuticals
Clinical Trial of Tafenoquine for Babesiosis at Tufts Medical Center; First and Only Study of Its Kind
WASHINGTON, June 27, 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 that the first patient has been enrolled
in a randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of tafenoquine in
treating babesiosis in humans. The patient was enrolled at Tufts Medical Center in Boston.
The study will enroll at least 24, and as
many as 33 people. It is the world's first and only clinical trial evaluating the efficacy and safety of tafenoquine in
human patients who have been diagnosed with acute babesiosis.
"With the first patient now enrolled
in this groundbreaking clinical study, we have moved into a key phase of development with tafenoquine as a potential
new treatment option in treating babesiosis," said Geoff Dow, PhD, chief executive officer at 60 Degrees Pharmaceuticals.
"Given both the growing prevalence of babesiosis and the difficulty of quickly differentiating it from other illnesses seen in the
clinic, we anticipate the numbers of people hospitalized with this serious tick-borne illness will continue to rise over time. In such
cases, babesiosis can certainly become life-threatening. Our goal is for tafenoquine to play an important role in safely
and effectively resolving babesiosis in those patients."
Babesiosis is a steadily emerging, tick-borne
disease transmitted through the bite of the black-legged (deer) tick, the vector that spreads Lyme disease. An orphan disease, babesiosis
may be life-threatening in elderly and immunosuppressed patients.
The Company is in discussions with other prominent
university hospitals to participate in the tafenoquine for babesiosis study.
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 U.S. Food and Drug Administration for such an indication.
60 Degrees Pharma recently announced tafenoquine has
been designated as an orphan drug by the U.S. Food and Drug Administration.
About the Tafenoquine in Babesiosis Study
The study is a randomized, double-blind, placebo-controlled trial enrolling patients in multiple sites in the Northeast U.S. comparing
the safety and efficacy of tafenoquine versus placebo in patients hospitalized for babesiosis, i.e., acute cases. 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 (NAT). 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 these patients 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 northeastern United States.
About 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
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 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, 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.
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,
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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