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

Company: 60 DEGREES PHARMACEUTICALS, INC.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 25
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 three clinical trials to aid further development
and commercialization of a Babesiosis indication for Tafenoquine. Trial 1 is a randomized, placebo-controlled, evaluation of Tafenoquine
in patients hospitalized with babesiosis who are also taking standard of care treatment (10 days of atovaquone-azithromycin). The primary
endpoint will be time to clinical recovery of 11 common babesiosis symptoms as reported by patients. Based on an analysis of blinded data
from the six patients who have completed the study to date and further advice from the FDA, we are planning to modify the key secondary
endpoint of time to molecular cure so it will be assessed using the commercially available Mayo clinic Babesia PCR assay rather than the
FDA-approved Babesia nucleic acid test that is used for blood donation screening. Additionally, the dosing regimen will be extended so
that Tafenoquine is administered at a dose of 200 mg/day on Days 1,2,3,4,11,18,25 and 32 (extended from administration of 200 mg/day on
Days 1,2,3&4). The study will enroll a minimum of 24 and up to 33 patients before an interim analysis is conducted, which will include
both a test of significance and a sample size re-estimation in case this is required. We have signed clinical trial agreements with Tufts
Medical Group, Yale, Rhode Island Hospital, and Brigham & Women’s Hospital. The first patient was randomized on June 25, 2024,
and six patients completed the study prior to implementation of the protocol modifications disclosed above. The earliest possible date
that date would be available from the interim analysis would be January 31, 2026, assuming a minimum of 24 patients are enrolled prior
to September 30, 2025. Further details are available on the clinicaltrials.gov website.35

    33
    Liu et
    al. Antimicrobial Agents Chemo 2021;65:e00204-21. Vydyam et al. J Infect Dis. 2024 Jan 3:jiad315. doi:10.1093/infdis/jiad315.

    34
    Marcos
    et al. IDCases 2022;27:e01460; Rogers et al. Clin Infect Dis. 2022 Jun 10:ciac473, Prasad and Wormsner. Pathogens 2022;11:101