60 Degrees Pharmaceuticals, Inc. (NASDAQ: SXTP; SXTPW) (the
“Company”), a pharmaceutical company focused on developing new
medicines for infectious diseases, announced today 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 human babesiosis
patients.
Recruitment of at least 24 hospitalized patients
diagnosed with babesiosis will begin after a site initiation visit
at Tufts Medical Center on June 13, 2024.
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, an orphan disease, 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 coinfected with Babesia.
“With tick-borne illnesses on the rise in the U.S.,
babesiosis is rapidly emerging as a condition of serious clinical
concern,” said Dr. Geoff Dow, chief executive officer at 60 Degrees
Pharmaceuticals. “The literature suggests
tafenoquine may be a promising alternative for the
treatment of patients hospitalized with relapsing babesiosis, so we
are pleased to partner with Tufts Medical Center to conduct the
first clinical trial of tafenoquine in treating
hospitalized babesiosis patients. The results may eventually lead
to an expanded indication for tafenoquine that
will address this growing public health concern.”
Tufts Medical Center is one of several prominent
university hospitals planning to participate in the study. 60
Degrees Pharmaceuticals is in negotiations with other leading
university hospitals in the Northeast U.S. to add two other
clinical trial sites.
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.
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. 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 (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 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.
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 Safety
Information ARAKODA® is an antimalarial indicated for the
prophylaxis of malaria in patients aged 18 years of age and
older.
ContraindicationsARAKODA® 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
PrecautionsHemolytic 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. 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
StatementsThis 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 timely manner, we may not be able to expand our
business operations; we may not be able to successfully conduct
planned clinical trials or patient recruitment in our trials might
be slow or negligible; and we have no manufacturing capacity which
puts us at risk of lengthy and costly delays of bringing our
products to market. More detailed information about the
Company and the risk factors that may affect the realization of
forward- looking statements is set forth in the Company’s filings
with the Securities and Exchange Commission (“SEC”),
including the information contained in our Annual Report on Form
10-K filed with the SEC on April 1, 2024, and our subsequent SEC
filings. Investors and security holders are urged to read these
documents free of charge on the SEC’s web site at www.sec.gov.
As a result of these matters, changes in facts, assumptions not
being realized or other circumstances, the Company’s actual results
may differ materially from the expected results discussed in the
forward-looking statements contained in this press release. Any
forward-looking statement made by us in this press release is based
only on information currently available to us and speaks only as of
the date on which it is made. We undertake no obligation to
publicly update any forward-looking statement, whether written or
oral, that may be made from time to time, whether as a result of
new information, future developments or otherwise.
Media Contact:Sheila A.
BurkeSheilaBurke-consultant@60degreespharma.com(484) 667-6330
Investor Contact:Patrick
Gaynespatrickgaynes@60degreespharma.com(310) 989-5666
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