60 Degrees Pharmaceuticals Announces Communication from the FDA of Intention to Respond to Tafenoquine-Babesiosis Trial Protocol Submission in April, 2024

WASHINGTON, March 14, 2024 (GLOBE NEWSWIRE) -- 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 that the U.S. Food and Drug Administration (FDA) has communicated its intention to send any comments regarding the Company’s babesiosis trial within the month of April, 2024, rather than March, 2024 as anticipated by the Company. The protocol submission mechanism as directed by the FDA, i.e., under the Company’s existing (rather than a new) Investigational New Drug application, technically does not require a response from the FDA within a specified time frame.

The Company is continuing preparations for a June 1, 2024 start date as previously communicated.

Tafenoquine is the active ingredient in an anti-malarial approved by the FDA in 2018 and is indicated for the prophylaxis of malaria in patients aged 18 years of age and older.

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.

ARAKODA (tafenoquine) Important Safety Information

ARAKODA is an antimalarial indicated for the prophylaxis of malaria in patients aged 18 years of age and older.

Contraindications

ARAKODA should not be administered to:

• Patients with Glucose-6-phosphate dehydrogenase (G6PD) deficiency or unknown G6PD status.
• Lactating women who are breastfeeding when the infant is found to be G6PD deficient or if G6PD status is unknown.
• Patients with a history of psychotic disorders or current psychotic symptoms.
• Patients with known hypersensitivity reactions to tafenoquine, other 8-aminoquinolines or any component of ARAKODA.

Warnings and Precautions