Company: SXTPW
Filing Date: 2025-01-30
Form Type: 424B5
Source: 0001213900-25-008098
Chunk: 61

Company: 60 DEGREES PHARMACEUTICALS, INC.
Filing Date: 2025-01-30
Form: 424B5
Chunk 61
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 or point of sale offer for travelers to offset out-of-pocket costs. We launched our Arakoda product website, which went live in April 2024. Revised Forecast.We have developed an internal forecast for the malaria and Babesiosis indications and have contracted a third party vendor to validate our analyses. Development of the Arakoda Regimen of Tafenoquine for Babesiosis In animal models, Tafenoquine monotherapy has been shown to suppress acute babesiosis infections to the point where the immune system can control them following single or multiple doses similar to those effective against malaria parasites, and longer regimens alone or in combination with atovaquone leads to complete radical cure and to the conference of sterile immunity. 34In three case studies in individuals with immunosuppression and/or refractory parasites, Tafenoquine alone or in combination with various standard of care antimalarials and antibiotics successfully cleared parasites, leading to three consecutive negative PCR tests, and prevention of further relapses in two of three individuals. 35Our market research has revealed that recent sales growth for Arakoda is primarily attributable to organic growth in prescribing by Lyme community prescribers for Chronic Babesiosis. Collectively these data suggest Tafenoquine might have utility alone or in combination as treatment or post-exposure prophylaxis of babesiosis (both acute and chronic). The Company is planning three clinical trials to aid further development and commercialization of a Babesiosis indication for Tafenoquine. Trial 1 is a randomized, placebo-controlled, evaluation of Tafenoquine (200 mg per day for a total of 800 mg) in patients hospitalized with babesiosis who are also taking standard of care treatment (10 days of atovaquone-azithromycin). The primary endpoint will be time to clinical recovery of 11 common babesiosis symptoms as reported by patients. The key secondary endpoint will be time to molecular cure as assessed by an FDA-approved Babesia nucleic acid test that is used for blood donation screening. 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. The study design was reviewed by the FDA. We have signed clinical trial agreement with Tufts Medical Group and are negotiating similar agreement with two other University Hospitals in the north eastern United States the study sites. The first patient was randomized on June 25, 2024. The earliest possible