Company: SXTPW
Filing Date: 2025-06-06
Form Type: DRS
Source: 0001213900-25-052232
Chunk: 15

Company: 60 DEGREES PHARMACEUTICALS, INC.
Filing Date: 2025-06-06
Form: DRS
Chunk 15
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 MMWR 202;70:1–35. |

| 18 | Queener et al JID 1997;165:764-768; Dow and Smith New Microb New Infect 2022;45:100964 |

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Viral Diseases Celgosivir, a potential clinical candidate of 60P’s, has activity in a number of animal models of important viral diseases such as Dengue and RSV. According to the European CDC, Dengue is associated with at least 4.1 million cases globally. 19And, according to the U.S. CDC, RSV is responsible for up to 240,000 hospitalizations in children less than five years of age and adults greater than 65 years of age in the United States each year. 20As outlined in the “ Strategy” section below, we expect to evaluate Celgosivir in additional non-clinical disease models before making a decision regarding clinical development. More information about our products is provided in the next section, and the status of various development efforts for the above-mentioned diseases is outlined in Figure A, below. Figure A Products Arakoda (Tafenoquine) for malaria prevention We entered into a cooperative research and development agreement with the United States Army in 2014 to complete development of Arakoda for prevention of malaria. 21With the U.S. Army, and other private sector entities as partners, we coordinated the execution of two clinical trials, development of a full manufacturing package, gap-filling non-clinical studies, compilation of a full regulatory dossier, successful defense of our program at an FDA advisory committee meeting and submitted a new drug application (“NDA”) to the FDA in 2018. The history of that collaboration has been publicly communicated by the U.S. Army. 22 The FDA and Australia’s medicinal regulatory agency, the Therapeutic Goods Administration, subsequently approved Arakoda (brand name in the U.S.) and Kodatef (brand name in Australia), respectively, for prevention of malaria in travelers in 2018. The features and benefits of Tafenoquine for malaria prophylaxis, some of which have been noted by third-party experts, include: convenient once weekly dosing following a three day load; the absence of reports of drug resistance during malaria prophylaxis; activity against liver and blood stages of malaria as well as both the major malaria species ( Plasmodium vivaxand Plasmodium falciparum