Full Press Release Details
60 Degrees Pharmaceuticals to Sponsor Pre-Clinical Studies of Tafenoquine
Use in Candida spp, Including Candida auris
Washington, D.C., February 20, 2024 - 60
Degrees Pharmaceuticals, Inc. (the "Company," "60P" or "60 Degrees Pharmaceuticals") (NASDAQ:
SXTP; SXTPW), specialists in developing and marketing medicines for infectious diseases, today announced it will, through its majority-owned
subsidiary 60P Australia Pty Ltd, sponsor a series of animal studies to investigate whether single dose parenteral administration of
tafenoquine exhibits efficacy against Candida spp, including Candida auris (C. auris). C. auris, a
strain of fungal yeast, is an emerging pathogen that poses risk of serious infection in the bloodstream and elsewhere, especially in
hospitalized patients.
The study will be conducted by Monash University in Melbourne, Australia,
beginning in the second quarter of 2024. Results are expected by the end of 2024.
Tafenoquine is the active ingredient in an anti-malarial approved
by the U.S. Food and Drug Administration (FDA) in 2018 and is indicated for the prophylaxis of malaria in patients aged 18 years of age
"The rapid transmission
of Candida auris in healthcare facilities is a very real threat and the need for a safe, effective treatment option
is becoming more urgent every day," said 60 Degrees Pharmaceuticals Chief Executive Officer and President, Geoff Dow. "This
important study could certainly yield valuable insights into how tafenoquine may be used toward that end. We are pleased to serve
as the study sponsor working with Monash University and look forward to reviewing results in coming months."
"It is well known that Candida
auris can cause severe illness in hospitalized patients," said Professor Anton Peleg, a Professor at Central Clinical School,
Monash University, and the principal investigator for the studies. "Even more concerning is the fact that many strains of this fungal
infection are now completely resistant to currently available therapies. We are optimistic that the results of our study using tafenoquine
will point the way toward development of a new treatment to address this clear, unmet medical need."
Microbes and New Infections recently published non-clinical study results showing tafenoquine exhibits broad spectrum
antifungal activity against several species of Candida, including C. auris, within in vitro broth culture. That research
was funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of
the National Institutes of Health (NIH).
Like other 8-aminoquinoline antimalarials, tafenoquine is expected
to kill fungi by disrupting cellular responses to oxidative stress, differentiating it from other antifungals.
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.
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.
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 the FDA for treatment or prevention of fungal infections.
ARAKODA (tafenoquine)
Important Safety Information
antimalarial indicated for the prophylaxis of malaria in patients aged 18 years of age and older.
ARAKODA should not be administered
Warnings and Precautions
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.
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 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. 60 Degrees Pharmaceuticals achieved FDA approval of its lead product, ARAKODA (tafenoquine)
for malaria prevention, in 2018. 60 Degrees Pharmaceuticals also collaborates with prominent research organizations in the U.S., Australia
and Singapore. The 60 Degrees Pharmaceuticals 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. 60 Degrees Pharmaceuticals is headquartered in Washington D.C., with a majority-owned subsidiary in Australia. Learn more at
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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
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