Full Press Release Details
60 Degrees Pharmaceuticals Suspends
Phase IIB Study of Tafenoquine for COVID-19, Pivots to Refocus on Commercialization of Treatments for Malaria and Tick-Borne Diseases
WASHINGTON, D.C., October
12, 2023 -- 60 Degrees Pharmaceuticals, Inc. (NASDAQ: SXTP; SXTPW) ("60P" or the "Company"), a pharmaceutical
company focused on developing new medicines for infectious diseases, announced that its subsidiary,
60P Australia Pty Ltd will not re-submit its investigational new drug application ("IND")
for ACLR8-LR, a Phase IIB study of tafenoquine compared to placebo in patients with mild to moderate COVID-19 disease and
low risk of disease progression. Tafenoquine is the active molecule in ARAKODA , the Company's U.S.
Food and Drug Administration (FDA)-approved regimen for malaria prevention. The Company's Board of Directors decided on October
6, 2023, that recent advice from the FDA made moving forward with the prior clinical development plan unfeasible.
The FDA has approved or authorized two marketed
oral products, Lagrevio and Paxlovid , for use in cases of mild-to-moderate COVID-19 disease to reduce the rate of hospitalizations
and deaths in patients with high risk of disease progression. However, the FDA has explicitly not authorized the use of those products
in patients with low risk of COVID-19 disease progression. Accordingly, Lagrevio and Paxlovid are not recommended by public
health agencies for that purpose.
Current literature on COVID-19 shows that
low risk patients have a very low risk of hospitalization. However, patients may wish to make a risk-based decision together with their
physician to use a therapeutic that accelerates clinical recovery from COVID-19 symptoms if such a therapeutic were available. FDA guidance
for industry implies that a regulatory pathway does exist for approval of new therapeutics that produce "sustained clinical recovery"
in COVID-19 patients. FDA-approved or authorized oral therapies have either failed or have not been studied against that endpoint.
early, published Phase IIA clinical data suggested the possibility of a 2 - 2.5 day improvement
in clinical recovery from cough, fever, and shortness of breath.1 Simulations of data from the same study suggested this might
also be the case for the FDA's preferred endpoint of "sustained clinical recovery" from all acute symptoms excluding
impaired taste and smell (see accompanying figure).
However, in a recent IND withdrawal acknowledgement
letter from the FDA, the agency implied that a placebo-controlled study in the U.S. is permissible only if study enrollment is "restricted
to a patient population in which nirmatrelvir/ritonavir or other approved or authorized therapeutics are not clinically appropriate."
As a practical matter, the population of patients
in the U.S. with medical contraindications to Paxlovid and Lagevrio is vanishingly small, which would make patient recruitment
very challenging. The Company also considered the FDA's recommended approach of a standard of care add-on design. However, such
a combination approach may not make clinical sense in a low-risk population or be Phase III enabling. In either case, the Company's
Board of Directors determined that raising capital to support a protracted development campaign, or one requiring three additional studies,
was not feasible in the current market environment.
Accordingly, as outlined in its registration
statement and subsequent communications to the investment community, 60P will instead continue to prepare to conduct a Phase IIA study
of tafenoquine in hospitalized babesiosis patients, with the goal of requesting a pre-IND meeting with FDA before the
An estimated 47,000 cases of babesiosis (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 increasing. Babesiosis is endemic in the U.S. Estimates are that 10% 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.
hire a commercial operations executive to expand its commercialization efforts related to ARAKODA (tafenoquine),
an antimalarial indicated for prophylaxis of malaria in patients 18 years and older and approved by the FDA in 2018. In the second quarter
of 2023, sales of ARAKODA increased by 150% relative to the same period in 2022, at an accelerating growth rate.
discovered by Walter Reed Army Institute of Research and the current study was funded by the Department of Defense's (DOD) Joint
Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense, in support of the Defense Health Agency, with the
goal of fielding a safe, effective treatment against COVID-19 by repurposing this FDA-approved drug (Contract: W911QY2190011). Tafenoquine
was approved for malaria prophylaxis in 2018 in the United States as ARAKODA (tafenoquine) 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. It has been
shown that tafenoquine inhibits SARS-CoV-2 replication in monkey kidney and human epithelial cells, and pharmacokinetic simulations
suggest lung levels at the FDA-approved dose for malaria prevention may exceed the EC90 of the drug. These data provided the rationale
for conducting the study of ARAKODA in mild-moderate COVID-19 patients. 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.
ARAKODA (tafenoquine)
Important Safety Information
is an antimalarial indicated for the prophylaxis of malaria in patients aged 18 years of age and older.
should not be administered to:
Warnings and Precautions
G6PD testing must be performed before prescribing ARAKODA due to the risk of hemolytic anemia. Monitor patients
for signs or symptoms of hemolysis.
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.
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%) were: headache, dizziness, back pain, diarrhea, nausea, vomiting, increased
alanine aminotransferase (ALT), motion sickness, insomnia, depression, abnormal dreams, and anxiety.
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
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
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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