60 Degrees Pharmaceuticals Advances ARAKODA for Chronic Babesiosis Treatment with Phase II Trial Approval

60 Degrees Pharmaceuticals, Inc. (NASDAQ: SXTP) has secured Investigational Review Board (IRB) approval to proceed with a Phase II clinical trial investigating ARAKODA® (tafenoquine) as a treatment for chronic babesiosis, marking a significant expansion beyond the drug's current approval for malaria prophylaxis.

The announcement triggered an impressive 79.03% surge in the company's stock price, reaching $1.38 in premarket trading, despite a year-to-date decline of 39.31% in the company's shares.

Addressing an Expanding Health Threat

Babesiosis, a tick-borne illness transmitted by black-legged (deer) ticks, has been spreading to new regions across the United States, particularly in the Northeast. The disease, caused by Babesia parasites, can produce symptoms ranging from fatigue and chills to potentially life-threatening complications, especially in immunocompromised individuals and the elderly.

Currently, there are no FDA-approved treatments specifically for chronic babesiosis, creating a significant unmet medical need. The company estimates that over 400,000 U.S. patients could potentially benefit from an effective treatment option.

ARAKODA's Therapeutic Potential

ARAKODA® (tafenoquine), initially discovered by the Walter Reed Army Institute of Research and approved for malaria prophylaxis in 2018, shows promising potential for treating babesiosis. The drug's long terminal half-life of approximately 16 days could offer advantages in treatment regimens through less frequent dosing.

The upcoming Phase II study, funded by the U.S. Army Medical & Materiel Development Activity, will evaluate both the safety and efficacy of tafenoquine in treating chronic babesiosis. Patient enrollment is scheduled to begin in Q3 2025.

Market Impact and Future Prospects

The development program could significantly impact both public health and 60 Degrees Pharmaceuticals' market position. With U.S. patent protection extending to 2035, successful trial results could establish ARAKODA® as a pioneering treatment in an underserved therapeutic area.

"The expansion of babesiosis into new geographic regions, coupled with the lack of approved treatments for chronic cases, makes this clinical study particularly timely and crucial," noted company representatives. The study's outcomes will be closely monitored by both the medical community and investors, as positive results could position 60 Degrees Pharmaceuticals as a leader in addressing this growing health concern.