Company: SXTPW
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001013762-25-003343
Chunk: 18

Company: 60 DEGREES PHARMACEUTICALS, INC.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 18
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 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 vivax and 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.23 Tafenoquine 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.24 The 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.25 G6PD 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 Candida and 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.26
Our work followed Legacy Studies that show Tafenoquine is effective for treatment and prevention of Pneumocystis pneumonia
in animal models.27 We believe that if added to the standard of care for anti-fungal and yeast infection treatments for general
use,