60 Degrees Pharma Provides University of Kentucky with Right of Reference to ARAKODA® NDA in Support of SJ733 Phase IIb Study
Clinical Study Announcement: The University of Kentucky will begin a Phase IIb clinical trial for the malaria treatment candidate SJ733, which will be combined with tafenoquine to evaluate its safety and efficacy against vivax malaria.
Regulatory Collaboration: 60 Degrees Pharmaceuticals has granted the University of Kentucky a right of reference to its NDA for tafenoquine, allowing the FDA to review relevant data as part of the new study protocols for the SJ733-tafenoquine combination.
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B-FREE Chronic Babesiosis Study: 60 Degrees Pharmaceuticals announced the launch of the B-FREE study, a Phase 2 trial evaluating the efficacy and safety of the ARAKODA regimen for treating chronic babesiosis, which will run for approximately 12 months.
Patient Engagement and Donation: The company engaged the patient community through a naming competition for the study, resulting in a $5,000 donation split between the Global Lyme Alliance and the International Lyme and Associated Diseases Education Foundation to support ongoing research and care.

New Drug Application for ARAKODA: 60 Degrees Pharmaceuticals plans to submit a New Drug Application for ARAKODA (tafenoquine) for the treatment of human babesiosis in 2026, contingent on positive results from three ongoing clinical trials.
Market Potential and Unmet Need: The total addressable market for ARAKODA in treating babesiosis is estimated at 380,000 patients with potential annual sales of $245 million, highlighting a significant unmet medical need due to the absence of FDA-approved treatments for this tick-borne illness.

New Product Launch: 60 Degrees Pharmaceuticals has introduced an 8-count bottle format for ARAKODA® (tafenoquine), a weekly prophylactic therapy for malaria prevention, now available at major retail pharmacies including Amazon Pharmacy.
Safety Information: ARAKODA® is indicated for adults aged 18 and older but has contraindications and warnings related to G6PD deficiency, psychiatric effects, and potential adverse reactions, necessitating careful patient monitoring.

Participation in Healing Lyme Summit: Geoff Dow, CEO of 60 Degrees Pharmaceuticals, will discuss the management and treatment of babesiosis at the Healing Lyme Summit from April 15–21, highlighting its rising prevalence and the need for better awareness and treatment options.
Clinical Trials on Tafenoquine: Dr. Dow will present information on two clinical trials evaluating the efficacy and safety of tafenoquine for treating severe babesiosis in immunosuppressed patients, emphasizing the urgency of addressing this public health threat.

Patent License Agreement: 60 Degrees Pharmaceuticals has signed a Patent License Agreement with Yale School of Medicine and Yale School of Public Health to develop tafenoquine for treating and preventing babesiosis, a tick-borne disease, which is currently not FDA-approved for this use.
Clinical Trial Initiation: The company is sponsoring a clinical trial to evaluate the efficacy and safety of tafenoquine in patients hospitalized with severe babesiosis, aiming to address the critical need for new treatments in immunocompromised individuals.

Company Offering Details: 60 Degrees Pharmaceuticals, Inc. closed a registered direct offering of 1,503,500 shares at $0.715 each, raising approximately $1.075 million for working capital and corporate purposes, alongside issuing short-term warrants in a concurrent private placement.
Company Background: Founded in 2010, 60 Degrees Pharmaceuticals specializes in developing medicines for infectious diseases, with its lead product ARAKODA® approved by the FDA for malaria prevention, and has received support from the U.S. Department of Defense and private investors.



