Full Press Release Details
60 Degrees Pharma Announces IRB Approval of Phase II Study to Evaluate
Tafenoquine for Chronic Babesiosis
WASHINGTON, D.C., January 28, 2025 -- 60 Degrees Pharmaceuticals,
Inc. (NASDAQ: SXTP; SXTPW) (the "Company"), a pharmaceutical company focused on developing new medicines for infectious diseases,
announced today the approval of an Investigational Review Board (IRB) sanctioned Phase II clinical study.
The study (NCT06656351) will evaluate the efficacy and safety of the
ARAKODA regimen (tafenoquine) over 90 days for treating patients with a presumptive diagnosis of chronic babesiosis. Participants
will have experienced significant functional impairment for at least six months. Patient enrollment is expected to begin in Q3 2025.
"As babesiosis continues to emerge in new regions of the U.S.,
the need to address its impact safely and effectively is also growing," said 60 Degrees Pharmaceuticals, Inc. Chief Executive Officer,
Geoff Dow, PhD. "The chronic phase of babesiosis particularly may prove to be one of the most important areas of study due to the
estimated large size of the patient population, the severity and duration of symptoms, and the absence of any approved treatment option
The Company estimates the total cumulative addressable market through
the end of U.S. patent protection in December 2035 for ARAKODA (tafenoquine) for babesiosis exceeds 400,000 patients.
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
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. Babesia
infection may persist for at least a year; fatigue is usually the symptom of infection that takes longest to resolve and may be debilitating
over the long term in some patients.
About ARAKODA (tafenoquine)
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 United
States Food and Drug Administration for such an indication.
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
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
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 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 at www.60degreespharma.com. The statements
contained herein may include prospects, statements of future expectations and other forward-looking statements that are based on management's
current views and assumptions and involve known and unknown risks and uncertainties. Actual results, performance or events may differ
materially from those expressed or implied in such forward-looking statements.
Cautionary Note Regarding Forward-Looking Statements
This press release may contain "forward-looking
statements" within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking
statements reflect the current view about future events. When used in this press release, the words "anticipate," "believe,"
"estimate," "expect," "future," "intend," "plan," or the negative of these
terms and similar expressions, as they relate to us or our management, identify forward-looking statements. Forward-looking statements
are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and
assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and trends, the economy,
activities of regulators and future regulations and other future conditions. Because forward-looking statements relate to the future,
they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside
of our control. Our actual results and financial condition may differ materially from those indicated in the forward-looking statements.
Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause our actual results and
financial condition to differ materially from those indicated in the forward-looking statements include, among others, the following:
there is substantial doubt as to our ability to continue on a going-concern basis; we might not be eligible for Australian government
research and development tax rebates; if we are not able to successfully develop, obtain FDA approval for, and provide for the commercialization
of non-malaria prevention indications for tafenoquine (ARAKODA or other regimen) or Celgosivir in a