60 Degrees Pharma Partners with University of Kentucky, ARAKODA® NDA Access Fuels Ambitious SJ733 Phase IIb Study

60 Degrees Pharmaceuticals, Inc.), a firm dedicated to developing innovative treatments for infectious diseases, announced today that it has provided the University of Kentucky with a right of reference to its new drug application (“NDA”) for ARAKODA® (tafenoquine).

Approved by the U.S. Food and Drug Administration (“FDA”) in 2018, ARAKODA is an anti-malarial medication indicated for malaria prevention in individuals aged 18 and older. This right of reference enables the FDA to access clinical efficacy and safety data, as well as non-clinical data and information on chemistry, manufacturing, and control for ARAKODA. This is part of the agency's review process for protocols and new Investigational New Drug (“IND”) applications related to the University of Kentucky’s Phase IIb program for SJ733.

SJ733 is an oral ATP4 inhibitor targeting Plasmodium, known for its favorable safety profile and quick anti-parasitic action. The Phase IIb study, conducted by the University of Kentucky in collaboration with Eisai Co. Ltd., will investigate the safety, tolerability, and pharmacokinetics of a single-dose combination of SJ733 and tafenoquine, the active ingredient in ARAKODA. This trial is supported by funding from the Global Health Innovative Technology Fund. Currently, the leading treatment for vivax malaria involves a three-day regimen of tafenoquine and chloroquine; however, resistance to chloroquine is becoming widespread in various regions worldwide.

Dr. R. Kip Guy, principal investigator on the Phase IIb study, and Professor and Dean of the University of Kentucky College of Pharmacy, said “Innovations in treating P. vivax malaria, which infects an estimated 14 million people a year, have been limited in recent decades. The upcoming study of SJ733 combined with tafenoquine has the potential to pave the way for very meaningful improvement in malaria treatment around the world.”

60 Degrees Pharma will provide tafenoquine and placebo medications for the Phase IIb trial being conducted at the University of Kentucky. Tafenoquine, marketed in the U.S. as ARAKODA®, is approved for the prevention of malaria. The safety profile of the approved tafenoquine regimen for malaria prophylaxis has been evaluated through five distinct randomized, double-blind trials, which included both active comparator and placebo-controlled groups, with study durations extending up to six months.