60 Degrees Pharmaceuticals, Inc. (NASDAQ: SXTP; SXTPW) (“60 Degrees
Pharmaceuticals” or the “Company”), a pharmaceutical company
focused on developing new medicines for infectious diseases, today
announced ethics approval of an open label, expanded access study
of the ARAKODA® regimen of
tafenoquine in
combination with standard of care regimens in immunosuppressed
patients with persistent/relapsing babesiosis.
The goal of the study is to confirm the findings of an 80
percent babesiosis cure rate in humans observed in a similar
population in an earlier case series of
tafenoquine completed by Yale School of Public
Health (YSPH) in April 2024 and published in the journal, Clinical
Infectious Diseases. The YSPH case series showed a cure rate (with
a 95 percent confidence interval) of 80 percent (30-100 percent) in
a series of five immunosuppressed patients who were administered
weekly tafenoquine following a loading dose in
combination with standard of care medications.
Tafenoquine is approved for malaria
prophylaxis in the United States under the product name
ARAKODA. Tafenoquine has not been proven to
be effective for treatment or prevention of babesiosis and is not
approved by the U.S. Food and Drug Administration
(FDA) for such an indication.
Babesiosis is a tick-borne illness caused
by Babesia parasites that develop and multiply in red
blood cells. Its symptoms include fevers, chills, sweats, and
fatigue, and in severe cases, can be life-threatening. Incidence of
the disease is rapidly rising, particularly in the
Northeast. Transmitted through the bite of the black-legged
(deer) tick, the vector that spreads Lyme disease, babesiosis is an
orphan disease. It may be life-threatening in elderly and
immunosuppressed patients.
“Tafenoquine is showing exciting promise in
addressing babesiosis within various human patient populations,”
said Chief Executive Officer of 60 Degrees Pharmaceuticals,
Geoffrey Dow, PhD. “With babesiosis rates now rising in key regions
of the United States and given the very serious nature of this
tick-borne illness, especially in the elderly and immunocompromised
people, we are moving quickly in an effort to confirm Yale’s
observations while advancing the clinical program for hospitalized
babesiosis patients which is now enrolling at Tufts Medical Center.
Ultimately, we aim to re-purpose tafenoquine as a
new babesiosis treatment.”
Sometimes called “compassionate use,” expanded access is a
potential pathway for a patient with a serious or immediately
life-threatening disease or condition to gain access to
an investigational medical product (drug, biologic, or
medical device) for treatment outside of clinical trials when no
comparable or satisfactory alternative therapy option is
available.
About the 60 Degrees Pharmaceuticals Program for
Tafenoquine in Babesiosis60 Degrees
Pharmaceuticals is engaged in advancing multiple clinical trials to
establish the safety and efficacy of tafenoquine.
They are the: 1.) study of hospitalized (i.e., acute) babesiosis
patients, now enrolling at Tufts Medical Center; 2.) expanded
access for Tafenoquine in Babesiosis trial
intended to confirm recent findings by Yale School of Public
Health; and 3.) expanded access study being planned for chronic
babesiosis, the design of which will be gated by an ongoing
epidemiological study at North Carolina State College of
Veterinary Medicine assessing whether Babesia spp
parasites are present in samples from human patients who have
chronic fatigue/neurologic symptoms.
The three studies address unmet medical need in three important
populations of human babesiosis patients: (i) patients hospitalized
with severe disease; (ii) patients with persistent disease who have
risk factors for relapse; and (iii) individuals with a diagnosis of
chronic babesiosis based on clinical manifestations and prior
medical history. Based on eventual data from all three trials, 60
Degrees Pharmaceuticals plans to file a New Drug Application with
the FDA in the second quarter of 2026 for a supplemental indication
for tafenoquine in babesiosis.
The Company believes that the total accessible market through
the end of patent protection in December 2035 in the U.S. for
ARAKODA (tafenoquine) for babesiosis is 38,000
(hospitalized and immunosuppressed) acute patients and at least
375,000 patients with chronic babesiosis. The prevalence of
patients with chronic disease may be higher and is the subject of
ongoing market research and epidemiological studies being conducted
by the Company. This is in addition to the potential 1.7 million
travelers who could benefit from the use of ARAKODA for malaria
prophylaxis over the same period.
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 ARAKODA®
(tafenoquine)Tafenoquine was discovered
by Walter Reed Army Institute of Research with funding from 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.
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
of 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. The
statements expressed herein are those of 60 Degrees
Pharmaceuticals, Inc. and do not necessarily represent those of the
U.S. Department of Defense.
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, 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; 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 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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