Company: SXTPW
Filing Date: 2025-03-27
Form Type: S-1/A
Source: 0001013762-25-003353
Chunk: 132

Company: 60 DEGREES PHARMACEUTICALS, INC.
Filing Date: 2025-03-27
Form: S-1/A
Chunk 132
---
 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
| 73 | 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. |

| 74 | Marcos                                                                                                                          
 et al. IDCases 2022;27:e01460; Rogers et al. Clin Infect Dis. 2022 Jun 10:ciac473, Prasad and Wormsner. Pathogens 2022;11:1015. |

| 75 | See:                                                     
 https://classic.clinicaltrials.gov/ct2/show/NCT06207370. |

80 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