Company: SXTPW
Filing Date: 2025-02-14
Form Type: S-1
Source: 0001213900-25-014334
Chunk: 20

Company: 60 DEGREES PHARMACEUTICALS, INC.
Filing Date: 2025-02-14
Form: S-1
Chunk 20
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 25, 2024, and six patients have now completed the study. 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. 36 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. 37

| 34 | 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.             |
| 35 | Marcos et al. IDCases 2022;27:e01460; Rogers et al. Clin                      
 Infect Dis. 2022 Jun 10:ciac473, Prasad and Wormsner. Pathogens 2022;11:1015. |
| 36 | See: https://classic.clinicaltrials.gov/ct2/show/NCT06207370.                 |
| 37 | See: https://clinicaltrials.gov/study/NCT06478641.                            |

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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