Company: SXTPW
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001013762-25-003343
Chunk: 14

Company: 60 DEGREES PHARMACEUTICALS, INC.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 14
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    (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 https://ysph.yale.edu/news-article/antimalarial-drug-is-effective-against-tick-borne-infection-babesiosis/.

6

    ●
    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 mirroring the human prophylactic
    dose in dogs might cost < $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 are already funding a pilot study at
    North Carolina State University related to this indication. Separately