Full Press Release Details
60 Degrees Pharma Plans Pivotal Babesiosis Study
with Tafenoquine Following Jan 17 FDA Meeting
January 22, 2024 12:59 PM EST
WASHINGTON, Jan. 22, 2024 (GLOBE NEWSWIRE) -- 60 Degrees
Pharmaceuticals, Inc. (NASDAQ: SXTP; SXTPW) ("60P" or the "Company"), a pharmaceutical company focused on developing
new medicines for infectious diseases, announced today that, following a Type C meeting held on January 17, 2024 with the US Food and
Drug Administration (FDA), the Company will move forward with a pivotal clinical study of tafenoquine
in hospitalized babesiosis patients in the U.S.
In advance of the meeting, 60P provided to the FDA an information
package that included a presentation of the unmet medical need for a new therapeutic for hospitalized babesiosis patients. It also included
a detailed outline of the proposed study protocol. The FDA indicated in remarks during the meeting that the proposed study could be sufficient
for regulatory approval, provided the Company uses a clinical endpoint rather than a surrogate marker. 60P is now revising the study protocol
in light of that feedback, with the goal of initiating patient enrollment in the summer of 2024.
meeting with the FDA led to mutual alignment with respect to the design of a development plan to evaluate the ARAKODA
regimen of tafenoquine for treating people who are
hospitalized with babesiosis," said Geoff Dow, Chief Executive Officer of 60 Degrees Pharmaceuticals. "We are excited to
advance this important study, as tick-borne illnesses such as babesiosis are emerging rapidly in the U.S. and can be life-threatening.
Our aim is to bring a new treatment option to healthcare providers seeking a safe, effective solution to address the needs of their hospitalized
patients diagnosed with this very serious condition."
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 co-infection rate of 10 percent.
is approved for malaria prophylaxis in patients aged 18 years and older 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.
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 Tafenoquine for Babesiosis Study
The 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 patients in the U.S. beginning in the summer of 2024. The study
will be conducted at three hospitals in the northeastern United States.
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.
An 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 2019, babesiosis was reportable in 40 states
and the District of Columbia.
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.
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.
(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
Anemia: G6PD testing must be performed before prescribing ARAKODA due
to the risk of hemolytic anemia. Monitor patients for signs or symptoms of hemolysis.
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.
Asymptomatic elevations in blood methemoglobin have been observed. Initiate appropriate therapy if signs or symptoms of methemoglobinemia
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.
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.
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
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