60 Degrees Pharmaceuticals, Inc. (NASDAQ: SXTP; SXTPW) (the
“Company” or “60 Degrees Pharma”), a pharmaceutical company focused
on developing new medicines for infectious diseases, announced
today that it has granted the University of Kentucky a right of
reference to the Company’s new drug application (“NDA”) for
ARAKODA® (
tafenoquine).
ARAKODA is the Company’s anti-malarial approved by the U.S. Food
and Drug Administration (“FDA”) in 2018, indicated for the
prophylaxis of malaria in patients aged 18 years of age and
older.
The right of reference will allow FDA to review clinical
efficacy and safety data, non-clinical data, and chemistry,
manufacturing and control information on ARAKODA as the agency
reviews protocols and new Investigational New Drug (“IND”)
application submissions related to the University of Kentucky’s
investigational SJ733 Phase IIb program.
SJ733 is an oral ATP4 inhibitor of Plasmodium, which has been
shown to have a favorable safety profile and rapid anti-parasitic
effect. The Phase IIb study being conducted by the University of
Kentucky and Eisai Co. Ltd. (“Eisai”) will combine SJ733 with
tafenoquine – the active ingredient in ARAKODA –
to evaluate the safety, tolerability, and pharmacokinetics of a
single-dose combination of the two drugs. The trial is funded by
the Global Health Innovative Technology Fund. The current
state-of-the-art treatment for vivax malaria is a combination of
tafenoquine and chloroquine administered over
three days; however, resistance of P. vivax to chloroquine is
widespread in some parts of the world.
“Innovations in treating P. vivax malaria, which infects an
estimated 14 million people a year, have been limited in recent
decades,” said Dr. R. Kip Guy, principal investigator on the Phase
IIb study, and Professor and Dean of the University of Kentucky
College of Pharmacy. “The upcoming study of SJ733 combined with
tafenoquine has the potential to pave the way for
very meaningful improvement in malaria treatment around the
world.”
60 Degrees Pharma will supply tafenoquine and
placebos as study drugs in the University of Kentucky Phase IIb
trial.
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.
About the SJ733 Phase IIb Clinical Trial at University
of Kentucky
The overall objective of the Phase IIb study is to examine the
clinical safety and efficacy of the combination of SJ733 and TQ for
radical cure of P. uncomplicated P. vivax malaria in adults with a
1, 2, or 3-day schedule of the SJ733-tafenoquine
combination. The purpose is to develop an SJ733-TQ combination drug
suitable for treatment of all patients with uncomplicated P. vivax
malaria. The targeted results for this study are data that support
1 to 3 doses of an SJ733-TQ fixed-dose combination for radical cure
of P. vivax mono-infected patients. This will set the stage for
subsequent pivotal Phase 3 studies.
SJ733 is a PfATP4 inhibitor that meets criteria
for treatment of uncomplicated malaria. Three clinical trials of
SJ733 have been completed. Phase I examined safety and
pharmacokinetics of SJ733. Phase I tested pharmacodynamics in the
human challenge model. Phase II (NCT04709692) determined the
parasite reduction ratio, parasite reduction half-life and minimum
inhibitory concentration of SJ733 in adults with uncomplicated
malaria and assessed the exposure-response relationship
(PK/PD). Current Phase Ia, Ib, and IIa human data show an
excellent safety profile and tolerability, good oral availability,
and moderate drug clearance.
Eisai and the University of Kentucky have collaboratively
designed the Phase IIb study and supportive non-clinical safety and
pharmacokinetics studies, which will be contracted to rigorously
qualified CROs and overseen by Eisai’s subject matter experts.
Eisai will manage the manufacture of a new batch of SJ733 clinical
trial material, as well as oversee conduct of the supportive
non-clinical safety and pharmacokinetics studies.
The University of Kentucky will oversee the regulatory filings
to amend the current US-FDA IND (held by Professor Guy) for
development of SJ733 and the Phase IIb clinical trial work,
including the local ethics and regulatory submissions.
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.
Contraindications
ARAKODA® 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 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 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.
Drug Interactions
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
three 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 for 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
for 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 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 website
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
This press release was published by a CLEAR® Verified
individual.
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