IRB Approval of Phase IIA Study to Evaluate Tafenoquine for Babesiosis

GlobeNewswire, Sixty Degrees Pharmaceuticals, 12.26.2023, reports on “60 Degrees Pharma Announces IRB Approval of Phase IIA Study to Evaluate Tafenoquine for Babesiosis, an Emerging Tick-Borne Disease; Type C Meeting Re-Scheduled by FDA to January 17, 2024.” This article from 60 Degrees Pharmaceuticals, Inc. highlights several key updates and developments regarding their investigational drug, tafenoquine, for the treatment of babesiosis, an emerging tick-borne disease. Babesiosis is a potentially life-threatening tick-borne illness on the rise in the United States, estimated to affect around 47,000 individuals annually. It’s often found in areas where Lyme disease is prevalent and can be transmitted through tick bites or contaminated blood transfusions.

60 Degrees Pharmaceuticals received approval from an Investigational Review Board (IRB) to conduct a Phase IIA clinical study. This study aims to evaluate the safety and effectiveness of tafenoquine in combination with standard care medications for hospitalized babesiosis patients. Tafenoquine is currently approved as ARAKODA® for malaria prophylaxis. Its long half-life suggests potential advantages in less-frequent dosing for malaria prevention.

The upcoming meeting presumably involves discussions about the development and potential approval of tafenoquine for treating babesiosis. The press release outlines important safety information regarding the use of ARAKODA® for malaria prophylaxis, indicating contraindications, warnings, precautions, and adverse reactions.


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Read the full article on GlobeNewswire’s website here.

Read LDA’s Post: Relapsing Babesiosis Case Treated Successfully with Tafenoquine

Read LDA’s Post: Tafenoquine as Treatment for Relapsing Babesiosis