Company: SXTPW
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001013762-25-003343
Chunk: 20

Company: 60 DEGREES PHARMACEUTICALS, INC.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 20
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-Feb;45:102211.
  
    24
    See prescribing information
    at www.arakoda.com.
  
    25
    See prescribing information
    at www.arakoda.com.
  
    26
    Dow and Smith, New Microbe
    and New Infect 2022; 45: 100964.
  
    27
    Queener et al Journal of
    Infectious Diseases 1992;165:764-8).
  
    28
    Liu et al. Antimicrobial
    Agents Chemo 2021;65:e00204-21, Marcos et al. IDCases 2022;27:e01460; Rogers et al. Clin Infect Dis. 2022 Jun 10:ciac473, Prasad
    and Wormsner. Pathogens 2022;11:1015.
  
    29
    Krause et al Clin Infect
    Dis 2024; doi:10.1093/cid/ciae238.

9

Celgosivir

Celgosivir
is a host targeted glucosidase inhibitor that was developed separately by other sponsors for HIV then for hepatitis C.30 The
sponsors abandoned Celgosivir after completion of Phase II clinical trials involving 700+ patients, because other antivirals in development
at the time had superior activity. The National University of Singapore initiated development of Celgosivir independently for Dengue
fever. A clinical study, conducted in Singapore, the results of which were accepted for publication in the peer-reviewed journal Lancet
Infectious Diseases, confirmed its safety but the observed reduction in viral load was lower than what the study was powered to detect.31
Celgosivir (as with other Dengue antivirals) exhibits greater capacity to cure Dengue infections in animal models when administered
prior to symptom onset when compared to administration post-symptom onset. In animal models, this problem can be addressed by administering
the same dose of drug split into four doses per day rather than two doses per day (as was the case in the Singaporean clinical trial).32
This observation led to the filing and approval of a patent related to Dengue, which we licensed from the National University of
Singapore.

Additional
clinical studies would be required to prove that such a 4x daily dosing regimen would be safe and effective in Dengue patients to regulators’
satisfaction. To that end, earlier