60 Degrees Pharmaceuticals, Inc. (“60 Degrees Pharmaceuticals” or
“60P”) (NASDAQ: SXTP), a company specializing in developing and
marketing medicines for infectious diseases, today announced that
ACLR8-LR, a double-blind, randomized, placebo-controlled Phase IIB
study to determine the efficacy of the ARAKODA
®
regimen of
tafenoquine in COVID-19 patients with
mild-moderate symptoms and low risk of disease progression, is now
listed on ClinicalTrials.gov.
The trial will be conducted by 60P’s majority-owned subsidiary,
60P Australia Pty Ltd, which opened a new IND on August 14,
2023.
The primary endpoint of ACLR8-LR is time to sustained clinical
recovery from COVID-19 symptoms. 60P plans to enroll patients in
ACLR8-LR, recruited in up to 30 out-patient clinics across the
U.S., beginning in the fourth quarter of 2023. 60P is also planning
a second, larger COVID-19 study that is anticipated to commence in
2024.
“Publicly registering ACLR8-LR represents an important milestone
in 60P’s clinical research strategy,” said Chief Executive Officer
of 60 Degrees Pharmaceuticals, Geoffrey Dow. “We remain optimistic
that results of ACLR8–LR will play an important role in public
health efforts to address gaps in the standard of care for
COVID-19.”
Public health interest in combating COVID-19 remains high.
Currently marketed orally administered COVID-19 therapeutics are
not appropriate for use by at least 25 percent of the U.S.
population who do not have risk factors for progression to severe
disease or by travelers who may wish to protect themselves from
COVID-19 for extended periods - an unaddressed multi-billion-dollar
market opportunity.
Data from a Phase II study published in New Microbes and New
Infections, Vol. 47, April – May 2022, a peer-reviewed, open-access
journal, suggested a positive therapeutic signal in mild-moderate
COVID-19 disease using the ARAKODA regimen of
tafenoquine; the time to clinical recovery from
COVID-19 symptoms was accelerated by about 2 – 2.5 days in the
tafenoquine arm.
In April, the United States Patent and Trademark Office (USPTO)
issued a patent covering the use of tafenoquine as
a treatment for COVID-19 disease. Tafenoquine is
the active molecule in 60P’s FDA-approved regimen for malaria
prevention, ARAKODA. 60P now owns the exclusive rights for the use
of tafenoquine for treatment of lung infections
including COVID-19 in the U.S. through 2040.
ARAKODA, an oral tablet containing 100 mg of a
tafenoquine base, is indicated for the prophylaxis
of malaria in patients aged 18 years and older for up to 6 months
of continuous dosing in the U.S. ARAKODA is not currently
FDA-approved for the treatment of symptoms caused by the COVID-19
virus.
About the ARAKODA®
Regimen of Tafenoquine for COVID-19
Clinical trial data suggesting the ARAKODA®
regimen of tafenoquine exhibits a positive
therapeutic signal in mild-moderate COVID-19 disease were published
last year in New Microbes and New Infections, Vol. 47, April – May
2022, a peer-reviewed, open-access journal. The drug increased the
proportion of clinically recovered patients by between 9 percent
(intent to treat population) and 14 percent (per protocol
population); the drug decreased the proportion of clinically
unrecovered patients by between 27 percent (intent to treat
population) and 47 percent (per protocol population). The study,
however, was underpowered to show statistical significance for the
primary endpoint due to early termination of the study at n=86
patients. Results also showed that time to clinical recovery from
COVID-19 symptoms was accelerated by about 2 – 2.5 days in the
tafenoquine arm of the double-blind, randomized,
placebo-controlled Phase II study.
About ARAKODA®
(tafenoquine)
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. It has been shown that
tafenoquine inhibits SARS-CoV-2 replication in
monkey kidney and human epithelial cells, and pharmacokinetic
simulations suggest lung levels at the FDA-approved dose for
malaria prevention may exceed the EC90 of the 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.
ARAKODA® (tafenoquine)
Important Safety Information
ARAKODA® is an antimalarial
indicated for the prophylaxis of malaria in patients aged 18 years
of age and older.
Important Safety Information
Contraindications
ARAKODA® should not be
administered to patients:
- With Glucose-6-phosphate dehydrogenase (G6PD) deficiency or
unknown G6PD status;
- Who are breastfeeding or lactating when the infant is found to
be G6PD deficient or if G6PD status is unknown;
- With a history of psychotic disorders or current psychotic
symptoms; or
- 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 ≥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 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 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 investment from 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
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 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 final prospectus to our Form S-1 (File No.: 333-269483) filed
with the SEC on July 13, 2023, and our subsequent annual reports on
Form 10-K and our 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 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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