Degrees Pharma Provides University of Kentucky with Right of Reference to ARAKODA NDA in Support of SJ733 Phase IIb Study Published

60 Degrees Pharma Provides University of Kentucky with Right of

Reference to ARAKODA NDA in Support of SJ733 Phase IIb Study

Aug 12, 2024 9:12am EDT

WASHINGTON, D.C., Aug.

12, 2024 -- 60 Degrees Pharmaceuticals, Inc. (NASDAQ: SXTP; SXTPW) (the "Company" or "60 Degrees Pharma"), a

pharmaceutical company focused on developing new medicines for infectious diseases, announced today that it has granted the University

of Kentucky a right of reference to the Company's new drug application ("NDA") for ARAKODA (tafenoquine).

ARAKODA is the Company's anti-malarial

approved by the U.S. Food and Drug Administration ("FDA") in 2018, indicated for the prophylaxis of malaria in patients aged

18 years of age and older.

The right of reference will allow FDA to review

clinical efficacy and safety data, non-clinical data, and chemistry, manufacturing and control information on ARAKODA as the agency reviews

protocols and new Investigational New Drug ("IND") application submissions related to the University of Kentucky's investigational

SJ733 Phase IIb program.

SJ733 is an oral ATP4 inhibitor of Plasmodium,

which has been shown to have a favorable safety profile and rapid anti-parasitic effect. The Phase IIb study being conducted by the University

of Kentucky and Eisai Co. Ltd. ("Eisai") will combine SJ733 with tafenoquine - the active ingredient in ARAKODA

- to evaluate the safety, tolerability, and pharmacokinetics of a single-dose combination of the two drugs. The trial is funded

by the Global Health Innovative Technology Fund. The current state-of-the-art treatment for vivax malaria is a combination of tafenoquine

and chloroquine administered over three days; however, resistance of P. vivax to chloroquine is widespread in some parts of the

"Innovations in treating P. vivax

malaria, which infects an estimated 14 million people a year, have been limited in recent decades," said Dr. R. Kip Guy, principal

investigator on the Phase IIb study, and Professor and Dean of the University of Kentucky College of Pharmacy. "The upcoming study

of SJ733 combined with tafenoquine has the potential to pave the way for very meaningful improvement in malaria treatment around

60 Degrees Pharma will supply tafenoquine

and placebos as study drugs in the University of Kentucky Phase IIb trial.

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.

About the SJ733 Phase IIb Clinical Trial

at University of Kentucky

The overall objective of the Phase IIb study is to examine the clinical

safety and efficacy of the combination of SJ733 and TQ for radical cure of P. uncomplicated P. vivax malaria in adults with

a 1, 2, or 3-day schedule of the SJ733-tafenoquine combination. The purpose is to develop an SJ733-TQ combination drug suitable

for treatment of all patients with uncomplicated P. vivax malaria. The targeted results for this study are data that support 1

to 3 doses of an SJ733-TQ fixed-dose combination for radical cure of P. vivax mono-infected patients. This will set the stage for

subsequent pivotal Phase 3 studies.

SJ733 is a PfATP4 inhibitor that meets criteria for treatment

of uncomplicated malaria. Three clinical trials of SJ733 have been completed. Phase I examined safety and pharmacokinetics of SJ733. Phase

I tested pharmacodynamics in the human challenge model. Phase II (NCT04709692) determined the parasite reduction ratio, parasite reduction

half-life and minimum inhibitory concentration of SJ733 in adults with uncomplicated malaria and assessed the exposure-response relationship

(PK/PD). Current Phase Ia, Ib, and IIa human data show an excellent safety profile and tolerability, good oral availability, and

moderate drug clearance.

Eisai and the University of Kentucky have collaboratively designed

the Phase IIb study and supportive non-clinical safety and pharmacokinetics studies, which will be contracted to rigorously qualified

CROs and overseen by Eisai's subject matter experts. Eisai will manage the manufacture of a new batch of SJ733 clinical trial material,

as well as oversee conduct of the supportive non-clinical safety and pharmacokinetics studies.

The University of Kentucky will oversee the regulatory filings to amend

the current US-FDA IND (held by Professor Guy) for development of SJ733 and the Phase IIb clinical trial work, including the local ethics

and regulatory submissions.

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. 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

ARAKODA is an antimalarial indicated

for the prophylaxis of malaria in patients aged 18 years of age and older.

ARAKODA should not be administered to:

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 16 days), psychiatric effects, hemolytic anemia, methemoglobinemia, and hypersensitivity reactions may be delayed in onset

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 three 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 for 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. 60 Degrees

Pharmaceuticals, Inc. achieved FDA approval for 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.