60 Degrees Pharmaceuticals, Inc. (NASDAQ: SXTP; SXTPW) (“60P” or
the “Company”), a pharmaceutical company focused on developing new
medicines for infectious diseases, announced today the approval of
an Investigational Review Board (IRB) sanctioned Phase IIA clinical
study. The study aims to investigate the efficacy and safety of the
ARAKODA® regimen of
tafenoquine in combination
with standard of care medications for treatment of hospitalized
babesiosis patients at lower risk of relapse.
Additionally, the U.S. Food and Drug Administration (FDA)
rescheduled the Company’s previously announced January 15 Type C
meeting to January 17, 2024, due to a federal holiday. The agenda
and all material submitted by SXTP to FDA in support of the Type C
meeting remain unchanged.
Babesiosis is a potentially life-threatening, tick-borne illness
steadily emerging in the United States. Total babesiosis patients
in the U.S. may be approximately 47,000 per year based on the
observation of 476,000 Lyme infections and an estimated babesiosis
coinfection rate of 10 percent.
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 FDA for such an indication.
About the Phase IIA Tafenoquine for Babesiosis
StudyThe Phase IIA study, titled, “Double-blind
Placebo-controlled Study to Assess the Safety and Efficacy of Oral
Tafenoquine plus Standard of Care versus Placebo plus Standard of
Care in Patients Hospitalized for Babesiosis,” is anticipated to
enroll at least 24 patients in the U.S., beginning in Q2 2024. The
primary endpoint of the study will be time to molecular cure as
determined by an FDA-approved nucleic acid test (NAT). The study
will be conducted at three hospitals in the northeastern United
States.
The efficacy and safety of 8-aminoquinolines, a class of drugs
that includes tafenoquine and primaquine, for
prevention and treatment of malaria is well established. The
appearance of several case studies of tafenoquine
use for babesiosis in the literature suggests that the drug is
being used for this purpose in the practice of medicine in the
U.S.
About BabesiosisAn estimated 47,000 cases of
babesiosis (i.e., infections caused by red blood cell parasites
similar to malaria that are transmitted by deer tick bites) occur
in the United States each year and the incidence rate is
steadily increasing. An estimated 10 percent of Lyme disease
patients are co-infected with babesiosis. The mortality rate of
babesiosis patients who have cardiac complications approaches 10
percent.
Babesiosis is spread by the bite of an infected blacklegged
tick, Ixodes scapularis. It can also be spread by transfusion of
contaminated blood.
Anyone can get babesiosis, but it can be more severe in the
elderly, people who have had their spleen removed, and in
people who have weakened immune systems (for example, those
who have cancer, HIV/AIDS, or a transplant). Most cases occur
in coastal areas in the Northeast and upper Midwest,
particularly in parts of New England, New York State, New Jersey,
Wisconsin, Minnesota and in some European countries. In the
Northeast, babesiosis occurs in both inland and coastal areas,
including offshore islands such as Nantucket and Martha’s Vineyard,
which are off Massachusetts, as well as in Long Island and the
Hudson Valley in New York State.
Hospitalizations as a result of babesiosis are usually seasonal,
occurring June through August. Clinical complications include
severe anemia, renal failure, cardiorespiratory failure, and
death. Babesiosis was designated a nationally notifiable
disease in the United States in 2011, meaning that states
where it was reportable were charged to voluntarily notify the
Centers for Disease Control and Prevention (CDC) of cases. As
of 2015, babesiosis was reportable in 33 states.
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.
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 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. 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 DOD 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
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 the information contained in the
final prospectus to our Registration Statement on Form S-1 (File
No.: 333-269483), as amended, initially filed with the SEC on
January 31, 2023 relating to our initial public offering, and our
subsequent Quarterly Report on Form 10-Q for the period ended June
30, 2023. 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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