60 Degrees Pharmaceuticals, Inc. (“60P”) (NASDAQ: SXTP),
specialists in developing and marketing medicines for infectious
diseases, today announced that 60P Australia Pty Ltd, a
majority-owned subsidiary of 60P, has withdrawn its investigational
new drug (IND) application for ACLR8-LR, a Phase IIB study of the
use of
tafenoquine in treating COVID-19, and
intends to submit a new IND in the fourth quarter.
The Company’s decision to withdraw the IND is in response to
recent comments from the U.S. Food and Drug Administration (FDA).
60P plans to submit a new IND to FDA within the current year,
pending an assessment of whether it is feasible to revise the trial
design to meet the agency's expectations while also allowing for
confirmation of the acceleration in recovery from COVID-19 symptoms
suggested by an earlier study.
In the interim, pending additional interaction with FDA, 60P has
paused further start-up activities for its Phase IIB trial
(ACLR8-LR), thereby decreasing the Company’s burn rate and
improving its cash position in the short term. Should the outcome
of further interactions with FDA be positive, and depending on
market conditions, the Company will make a decision regarding
whether to continue its original strategy of self-funding its Phase
IIB study or to seek a strategic partner to continue
development.
In parallel, as outlined in its registration statement and
subsequent communications to the investment community, 60P plans to
continue preparation of a Phase IIA study of
tafenoquine in hospitalized babesiosis patients,
with the goal of requesting a pre-IND meeting with FDA before the
end of the calendar year.
At estimated 47,000 cases of babesiosis (red blood cell
infections caused by deer tick bites) occur in the United States
each year, and the incidence is increasing. Babesiosis is endemic
in the U.S. Estimates are that 10 percent of Lyme disease patients
are co-infected with babesiosis. Post-exposure prophylaxis
following a tick bite is a recognized indication to prevent Lyme
disease, and it is likely that a drug proven to be effective for
this indication for babesiosis would also be used in conjunction
with Lyme prophylaxis.
60P plans to continue its commercialization efforts related to
ARAKODA® (tafenoquine), an antimalarial indicated for prophylaxis
of malaria in patients 18 years and older and approved by FDA in
2018. In Q2 2023, sales of ARAKODA increased by 150 percent
relative to the same period of 2022.
“A clear unmet need remains to provide a safe, effective
treatment for the low-risk COVID-19 patient population and we have
seen that tafenoquine holds promise in meeting
that need,” said 60 Degrees Pharmaceuticals CEO, Dr. Geoff Dow.
“While we determine whether moving forward in modifying ACLR8-LR
such that it meets FDA’s requirements is feasible, we will continue
existing efforts related to expansion of our commercial malaria
business and submission of an IND for further study of how
tafenoquine may be effective in combatting
babesiosis.”
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 babesiosis.
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
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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