Company: SXTPW
Filing Date: 2025-01-30
Form Type: 424B5
Source: 0001213900-25-008098
Chunk: 55

Company: 60 DEGREES PHARMACEUTICALS, INC.
Filing Date: 2025-01-30
Form: 424B5
Chunk 55
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 experts, include: convenient once weekly dosing following a three day load; the absence of reports of drug resistance during malaria prophylaxis; activity against liver and blood stages of malaria as well as both the major malaria species ( Plasmodium vivaxand Plasmodium falciparum); absence of any black-box safety warnings; good tolerability, including in women and individuals with prior psychiatric medical history; and a comparable adverse event rate to placebo with up to 12 months continuous dosing. 24Tafenoquine entered the commercial supply chains in the U.S. and Australia in the third quarter of 2019. The only limitation of Arakoda is the requirement for a G6PD test prior to administration. 25The G6PD test must be administered to a prospective patient prior to administration of Arakoda in order to prevent the potential occurrence of hemolytic anemia in individuals with G6PD deficiency. 26G6PD is one of the most common enzyme deficiencies and is implicated in hemolysis following administration/ingestion of a variety of oxidant drugs/food. G6PD must also be ruled out as a possible cause when diagnosing neonatal jaundice. As a consequence, G6PD testing is widely available in the United States through commercial pathology service providers (e.g., Labcorp, Quest Diagnostics, etc.). Although these tests have a turn-around time of up to 72 hours, the test needs only to be administered once. Thus, existing U.S. testing infrastructure is sufficient to support the FDA-approved use of the product (malaria prevention) by members of the armed forces (who automatically have a G6PD test when they enlist), civilian travelers with a long planning horizon, or repeat travelers. Tafenoquine for Other (Infectious) Diseases During the pandemic, we also worked with NIH to evaluate the utility of Tafenoquine as an antifungal. We, and the NIH, found that Tafenoquine exhibits a Broad Spectrum of Activity in cell culture against Candidaand other yeast strains via a different Mode of Action than traditional antifungals and also exhibits antifungal activity against some fungal strains at clinically relevant doses in animal models. 27Our work followed Legacy Studies that show Tafenoquine is effective for treatment and prevention of Pneumocystispneumonia in animal models. 28We believe that if added to the standard of care for anti-fungal and yeast infection treatments for general use,