60 Degrees Pharmaceuticals, Inc. (“60P”) (NASDAQ: SXTP),
specialists in developing and marketing medicines for infectious
diseases, today announced the journal, New Microbes and New
Infections, has published non-clinical study results showing
tafenoquine exhibits broad spectrum antifungal
activity, including against Candida spp. in cell culture, and
decreases fungal burden in the lungs in an invasive pulmonary model
of Rhizopus in mice.
New Microbes and New Infections is a peer-reviewed, open-access
journal. The research was funded by the National Institute of
Allergy and Infectious Diseases (NIAID), part of the National
Institutes of Health (NIH).
Tafenoquine is the active ingredient in an
anti-malarial approved by the FDA in 2018 and is indicated for the
prophylaxis of malaria in patients aged 18 years of age and older.
60P was recently awarded a U.S. patent covering
tafenoquine for treatment of COVID-19 and other
lung infections.
“A substantial unmet need exists for clinical therapies that
treat and prevent life-threatening fungal infections,” said Chief
Executive Officer of 60 Degrees Pharmaceuticals, Geoffrey Dow.
“Even when antifungal treatments approved by the FDA are
administered to patients, the morbidity, mortality, and clinical
incidence of rapidly emerging, dangerous fungal infections such as
Candida and Rhizopus remain high. Data from this set of studies
confirm that tafenoquine holds promise in
addressing that unmet need in the U.S. It is particularly
interesting that tafenoquine did not exhibit any
cross-resistance to fluconazole against Candida species, and that
the presumed mode of action, through the induction of oxidative
stress, differs from standard of care treatments. We are pursuing
this hypothesis as part of our research strategy.”
About Candida auris (C. auris)
and Rhizopus
Candida auris (C. auris) is an
emerging fungus that presents a serious global health threat,
according to the Centers for Disease Control and Prevention (CDC).
C. auris is often multi-drug-resistant, meaning that it is
resistant to multiple antifungal drugs commonly used to
treat Candida infections.
C. auris carries a high mortality
rate, killing more than 1 in 3 people with infections. Infections
often emerge in healthcare settings, where people are particularly
vulnerable. Rates are rising; the CDC reports annual cases of
C.auris in the United States have risen from fewer than 500 in 2019
to nearly 1,500 in 2023.
Rhizopus species, one of the most common types of
mucormycetes that cause mucormycosis, is a rare, life-threatening
fungal infection that primarily affects immunocompromised humans,
with an estimated mortality rate of 23–100 percent. Humans contract
mucormycosis through contact with the fungal spores in the
environment. The pulmonary form of the infection can occur after a
person inhales the spores. Pulmonary and GI mucormycosis due
to Rhizopus in children can be fatal when not promptly
diagnosed and treated. In immunocompromised patients, the disease
is typically progressive and frequently fatal.
About the Tafenoquine Antifungal Study Minimum
inhibitory concentrations (MICs) of medically important fungal
pathogens were determined using conventional cell culture assays.
The daily maximum tolerated dose (MTD) of
tafenoquine was determined in neutropenic mice and
the effect of two dose levels of tafenoquine on
survival and fungal burden were assessed in Rhizopus and
Aspergillus lung infections models. Mean MICS against panels of
yeasts and dimorphic/filamentous fungi were 4.5 and 8.3 ug/mL. The
MTD of tafenoquine was 5 mg/kg/day. Against
Aspergillus, tafenoquine at the MTD did not
increase survival or decrease fungal burden. Against Rhizopus,
tafenoquine at the MTD decreased lung fungal
burden in a dose-related manner. Survival in the high-dose MTD
tafenoquine group was 30 percent whereas it was 0
percent in the vehicle group and in most legacy studies.
This research has used the NIAID suite of preclinical services
for in vitro and in vivo assessments (Contract No.
HHSN272201700039I 75N93019F00131).
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.
Neither ARAKODA nor tafenoquine has
been approved by FDA for treatment or prevention of fungal
infections.
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:
- Patients with Glucose-6-phosphate dehydrogenase (G6PD)
deficiency or unknown G6PD status
- Lactating women who are breastfeeding 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
- Patients with known hypersensitivity reactions to tafenoquine,
other 8-aminoquinolines, or any component
of ARAKODA.
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 (ALT), motion sickness, insomnia, depression,
abnormal dreams, and anxiety.
Drug
InteractionsAvoid 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 at 1- 888-834-0225 or FDA at
1-800-FDA-1088
or www.fda.gov/medwatch. ARAKODA full
prescribing information is 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. 60P successfully
achieved FDA approval of its lead product, ARAKODA® (tafenoquine),
for malaria prevention, in 2018. 60P also collaborates with
prominent research organizations in the U.S., Australia and
Singapore. 60P’s mission has been supported through in-kind funding
from the United States Department of Defense and private
institutional investors including Knight Therapeutics Inc., a
Canadian-based pan-American specialty pharmaceutical company. 60P
is headquartered in Washington D.C., with a majority-owned
subsidiary in Australia. Learn more at www.60degreespharma.com.
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 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; 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 our Annual Report on Form 10-K and our subsequent
Quarterly Reports on Form 10-Q. 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
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Company’s actual results may differ materially from the expected
results discussed in the forward-looking statements contained in
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to us and speaks only as of the date on which it is made. We
undertake no obligation to publicly update any forward-looking
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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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