Company: SXTPW
Filing Date: 2025-07-07
Form Type: S-1
Source: 0001213900-25-061842
Chunk: 15

Company: 60 DEGREES PHARMACEUTICALS, INC.
Filing Date: 2025-07-07
Form: S-1
Chunk 15
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% of Lyme disease patients are co-infected with babesiosis and that according to Krause et al (AJTMH 2003;6:431-436) fact that about 80% of cases are symptomatic (thus 476,000*10%*80% = 38,000 cases of babesiosis per year). |

| 10 | Bloch et al Open Forum Infect Dis 2022;9(11):ofac597. |

| 11 | According to IDSA guidelines. |

| 12 | See Krause et al Clin Infect Dis 2024; doi:10.1093/cid/ciae238 and Yale School of Public Health |

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| ● | Prevention of Tick-Borne Diseases. Post-exposure prophylaxis or early treatment with, respectively, a single dose or several week regimen of doxycycline following a tick-bite is a recognized indication to prevent the complications of Lyme disease. There may be more than 400,000 such tick bites in the United States requiring medical treatment each year. This estimate is based on the observation that approximately 50,000 tick bites are treated in U.S. hospital emergency rooms each year; however, this calculation represents only about 12% of actual treated tick bites based on observations from comparable ex-U.S health systems.13 Unlike Lyme disease, there is no characteristic rash associated with early infection and no reliable diagnostic tests. Thus, an individual bitten by a tick cannot know whether they have also been infected with babesiosis. It is likely that a drug proven to be effective for this indication for babesiosis would also be used in conjunction with Lyme prophylaxis. |

| ● | Veterinary Indications. Based on estimates from industry experts, there may be somewhere between several hundred and several thousand cases of canine babesiosis each year in the United States, and thousands more globally. Currently, standard of care treatment for babesiosis in dogs is a ten-day course of atovaquone and azithromycin, which costs about $1,350 out of pocket. A treatment course of Tafenoquine comprising a single 16-count packet of Arakoda might cost less than $300, offering a compelling alternative to standard of care. The additional resources required to generate enabling data for veterinary uses are much less expensive than human clinical trials and we have completed pilot study at North Carolina State University related to this indication. Separately, the Company is exploring the potential utility of Tafenoquine to