Company: SXTPW
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001013762-25-003343
Chunk: 26

Company: 60 DEGREES PHARMACEUTICALS, INC.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 26
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5.

    35
    See: https://classic.clinicaltrials.gov/ct2/show/NCT06207370.

11

Trial 2 will be an expanded use study utilizing
commercially available Arakoda. The Company, if approved by an Institutional Review Board (“IRB,” also known as an ethics
committee), plans to offer up to one year of Arakoda at no cost to about 10 patients per year (i.e., immunocompromised patients who have
previously failed standard of care treatment). Informed consent will be obtained from patients to collect a blood sample for PCR testing
at the end of treatment, and patients will be asked to complete a babesiosis symptom questionnaire. The goal of the study is to generate
additional prospective data to confirm the observation by Krause et al in a recent publication that an extended regimen of Tafenoquine
cured 80% of immunocompromised patients with relapsing babesiosis. As of the date of this filing, we had enrolled one patient in this
study. More details about the study can be found on the clinicaltrials.gov website.36

Trial 3 will be a Phase II open label study utilizing commercially
available Arakoda. The Company, plans to offer an approximately three-month supply of Arakoda at no cost to patients who have a clinical
diagnosis, are willing to submit biological samples for testing, and answer babesiosis and standardized fatigue inventories before and
after treatment. The goal of this study will be to ascertain whether Arakoda treatment improves patient-reported fatigue symptoms in individuals
who have symptoms of severe fatigue lasting more than six months and a diagnosis of chronic babesiosis. Secondary objectives include assessing
confirmable Babesia infection rates in these populations using validated molecular assays, and assessing the safety and tolerability
profile of Arakoda in this patient population.

In May 2024, we signed a research and collaboration
agreement with North Carolina State University in which the College of Veterinary Medicine will screen archived blood samples from 50
patients exhibiting symptoms consistent with chronic fatigue symptoms by PCR for the presence of Babesia spp by digital PCR and DNA sequencing.
This work is now complete, and a manuscript for publication is now in preparation. While the data cannot be disclosed at this time, the
Company believes they are supportive of the feasibility of executing Trial 3.

We believe, if the Company does not become capital-limited,
and no recruitment issues are encountered, that the results