60 Degrees Pharmaceuticals Partners for Chronic Babesiosis Study

Significant Milestone in Babesiosis Treatment Research

60 Degrees Pharmaceuticals, Inc. (NASDAQ: SXTP; SXTPW) has made a groundbreaking announcement about its collaboration with the Icahn School of Medicine at Mount Sinai. This partnership marks the selection of Mount Sinai as the central clinical trial site for a vital Phase II study aimed at evaluating the effectiveness of tafenoquine in treating chronic babesiosis, a disease that is increasingly affecting public health.

Understanding Chronic Babesiosis

Chronic babesiosis is a serious tick-borne illness caused by Babesia parasites that impact red blood cells. Patients suffering from this condition often experience debilitating fatigue along with other symptoms over prolonged periods. As of now, there is no FDA-approved treatment specifically for chronic babesiosis, making this study particularly crucial as it seeks to explore new therapeutic options.

Details of the Clinical Trial

The upcoming clinical trial is designed to run for a period of 90 days, focusing primarily on changes in general fatigue among patients diagnosed with chronic babesiosis. Enrollment for participants is expected to begin towards the end of 2025, with completion anticipated in mid-2026. This timeline illustrates the urgency and dedication behind finding effective treatments for this challenging illness.

Expertise at Mount Sinai

The Icahn School of Medicine is recognized for its extensive expertise in infectious disease trials and provides access to a diverse and robust patient population dealing with tick-borne illnesses, including chronic babesiosis. This collaboration is expected to significantly enhance the trial's outcomes, benefitting from the researchers' profound knowledge in the field.

The tafenoquine Approach

Tafenoquine, the drug in focus, is already approved in the United States for malaria prophylaxis under the brand name ARAKODA^®. While it has shown success in malaria prevention, its use for treating babesiosis is still unapproved, so this clinical trial serves an important role in assessing its potential effectiveness for this different indication. Over the course of the trial, patients will take tafenoquine orally and will be monitored for changes in their fatigue levels, utilizing a patient-reported outcome measure throughout the evaluation process.

Leadership Perspectives

Geoff Dow, PhD, the Chief Executive Officer of 60 Degrees Pharmaceuticals, expressed his enthusiasm about the partnership with the Icahn School of Medicine. He highlighted the importance of this collaboration in advancing research on tick-borne diseases, stating, "We are pleased to welcome the Icahn School of Medicine at Mount Sinai research team into the 60 Degrees Pharma tafenoquine for babesiosis clinical trial program. They bring deep expertise and skill in researching tick-borne illnesses, along with a focus on supporting the development of novel therapies to meet the critical unmet needs of patients with chronic disease."

Future Directions for Tafenoquine

In addition to this Phase II study, several other clinical trials sponsored by 60 Degrees Pharmaceuticals are either currently underway or planned, all aiming to further evaluate the safety and efficacy of tafenoquine for babesiosis treatment. Results from these trials are expected to emerge in the first half of 2026 and will contribute to a planned New Drug Application (NDA) to the U.S. Food and Drug Administration, targeting approval for babesiosis treatment in 2026.

Babesiosis: An Orphan Disease

Babesiosis is classified as an orphan disease, meaning that it receives less attention in terms of research and treatment compared to more common illnesses. Due to its rising incidence rates, particularly in certain regions, the urgent need for effective therapeutic solutions grows increasingly clear. Patients often struggle with symptoms that can linger for extended periods, hindering their quality of life significantly.

About 60 Degrees Pharmaceuticals, Inc.

Founded in 2010, 60 Degrees Pharmaceuticals, Inc. emphasizes the development and commercialization of new medicines targeted at vector-borne diseases. The company's flagship product ARAKODA^® was granted FDA approval in 2018, now available in both the U.S. and Australia. Committed to advancing public health, 60 Degrees Pharmaceuticals works closely with top-tier research and academic institutions and is headquartered in Washington, D.C.

Frequently Asked Questions

What is chronic babesiosis?

Chronic babesiosis is a tick-borne illness caused by Babesia parasites, leading to severe fatigue and other symptoms lasting for months.

What is tafenoquine?

Tafenoquine is a medication approved for malaria prophylaxis under the name ARAKODA^® and is being studied for its potential to treat babesiosis.

How long will the clinical trial last?

The Phase II clinical trial is expected to last for 90 days, with participant enrollment beginning in Q4 2025.

Where is the clinical trial being held?

The Icahn School of Medicine at Mount Sinai will serve as the central site for this clinical trial.

What is the goal of this clinical trial?

The trial aims to evaluate the efficacy and safety of tafenoquine in treating chronic babesiosis, particularly looking at the resolution of fatigue in patients.

About The Author

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