Tafenoquine for Babesiosis

(TQ-BA-2024-3 Trial)

Overseen By Core Research

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: 60 Degrees Pharmaceuticals LLC

Must not be taking: Quinine, OCT2/MATE substrates

Disqualifiers: G6PD deficiency, HIV/AIDS, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: 120

Duration: 12 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the effectiveness of the drug tafenoquine in treating chronic babesiosis, a condition that often causes severe fatigue, chills, and muscle aches. Participants will self-administer the medication over a 12-week period to assess its impact on symptoms. The trial seeks individuals who have experienced severe fatigue and have evidence of babesiosis exposure in the past year. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important medical advancements.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently or planning to be treated with quinine or taking certain medications without proper medical oversight. It's best to discuss your current medications with the trial team.

Is there any evidence suggesting that tafenoquine is likely to be safe for humans?

Previous studies have led to FDA approval of tafenoquine for preventing malaria, demonstrating its safety for that use. However, the FDA has not yet approved it for treating babesiosis. Research on tafenoquine for babesiosis continues.

Tafenoquine has been combined with other treatments for babesiosis. Although limited safety information exists for its use in babesiosis, its approval for malaria suggests it is generally well-tolerated. Studies on babesiosis are still underway, and more information will clarify its safety for this condition. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Tafenoquine is unique because it offers a new approach to treating babesiosis. Unlike the standard treatments like atovaquone or azithromycin, which often require frequent dosing, tafenoquine is taken less frequently, potentially improving patient adherence. Additionally, tafenoquine has a long half-life, which might provide a more sustained action against the parasites causing the disease. Researchers are excited about its potential to simplify the treatment regimen while maintaining effectiveness.

What evidence suggests that tafenoquine might be an effective treatment for babesiosis?

Research has shown that tafenoquine holds promise for treating babesiosis. In this trial, participants will receive tafenoquine alone. Studies have found that tafenoquine, when used by itself, effectively eliminates drug-resistant strains of Babesia in lab tests. Another study discovered that combining tafenoquine with atovaquone completely cured human babesiosis in models, with no return of the parasite. These findings suggest tafenoquine could help with chronic babesiosis that causes severe tiredness. Overall, the evidence supports tafenoquine's potential to treat this condition. ^{3 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for individuals who have been diagnosed with chronic babesiosis and are experiencing severe disabling fatigue. Participants must be able to consent, perform all study assessments, and if female, not be pregnant and agree to use birth control.

Inclusion Criteria

I am female and my pregnancy test is negative.

I am willing and able to sign a consent form.

I am willing and able to follow all study procedures.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants self-administer Tafenoquine orally with food on Days 1, 2, 3, 4, then weekly thereafter for a total 12-week treatment period

12 weeks

Weekly visits (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Visits on Days 120 and 180

What Are the Treatments Tested in This Trial?

Interventions

• Tafenoquine

Trial Overview

The B-FREE Chronic Babesiosis Study is a Phase 2 trial where patients receive Tafenoquine at a dose of 100mg. It's an open-label study which means everyone knows they're getting the medication, aimed at treating those with severe fatigue due to chronic babesiosis.

How Is the Trial Designed?

Group I: Tafenoquine Experimental Treatment 1 Intervention

Tafenoquine (2 x 100 mg tablets) will be self-administered orally with food on Days 1, 2, 3, 4, then weekly thereafter for a total 12-week treatment period. Weekly treatment will start on Day 11 and end on Day 89.

Who Is Running the Clinical Trial?

60 Degrees Pharmaceuticals LLC

Lead Sponsor

Trials

6

Recruited

760+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10786256/

Tafenoquine-Atovaquone Combination Achieves Radical ...

We demonstrate that a combination of tafenoquine and atovaquone achieves cure with no recrudescence in experimental models of human babesiosis.

2.

medicine.yale.edu

medicine.yale.edu/news-article/babesiosis-researchers-discover-a-new-combination-therapy-effective-against-drug-sensitive-and-resistant-parasites/

Babesiosis: Researchers Discover a New Combination ...

Once again, they found that tafenoquine, as a monotherapy, was highly effective in clearing resistant B. ducani strains from the mice.

3.

academic.oup.com

academic.oup.com/jid/article-abstract/229/1/161/7505227

Tafenoquine-Atovaquone Combination Achieves Radical ...

We further show that a combination of tafenoquine and atovaquone achieves cure with no recrudescence in both models of human babesiosis.

4.

journals.asm.org

journals.asm.org/doi/10.1128/aac.00204-21

Tafenoquine Is a Promising Drug Candidate for the Treatment ...

In this study, we evaluated the efficacy of TAF for the treatment of Babesia infection and elucidated the suspected mechanisms of TAF activity against Babesia ...

5.

clinicaltrialsarena.com

clinicaltrialsarena.com/news/60-degrees-babesiosis-trial/

60 Degrees to commence Phase II babesiosis trial at ...

... tafenoquine's efficacy and safety in treating babesiosis in humans. Results from at least one of these trials are expected in the first half ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11259219/

Tafenoquine for Relapsing Babesiosis: A Case Series - PMC

Our results suggest that successful use of tafenoquine for babesiosis depends on concurrent treatment with other antimicrobial agents. In ...

7.

investors.60degreespharma.com

investors.60degreespharma.com/news-releases/news-release-details/60-degrees-pharmaceuticals-announces-no-detection-babesia

60 Degrees Pharmaceuticals, Inc.

Tafenoquine is not currently approved by the FDA for the treatment and prevention of babesiosis. Tafenoquine is approved for malaria prophylaxis ...

8.

academic.oup.com

academic.oup.com/jid/article-abstract/230/1/271/7660017

Planned Trial to Evaluate the Safety and Efficacy of ...

Our study will evaluate (1) time to resolution of 11 of 18 common babesiosis symptoms [4] based on a patient-reported outcome tool and (2) time to molecular ...

9.

biospace.com

biospace.com/60-degrees-pharma-to-present-review-of-safety-efficacy-data-of-8-aminoquinolines-for-malaria-and-babesiosis-treatment-at-ilads-annual-scientific-meeting-in-boston

60 Degrees Pharma to Present Review of Safety, Efficacy ...

Tafenoquine has not been proven to be effective for treatment or prevention of babesiosis and is not approved by the FDA for such indications.