Tafenoquine for Babesiosis

Overseen By Geoff Dow

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: 60 Degrees Pharmaceuticals LLC

Must be taking: Antimicrobials

Must not be taking: Quinine

Disqualifiers: Significant illness, Pregnancy, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 4 days

33 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effectiveness of a drug called Tafenoquine for treating babesiosis, a tick-borne infection that can cause flu-like symptoms. Participants will receive either Tafenoquine or a placebo (a pill with no active medicine) along with the usual antimicrobial treatment. Suitable candidates have a confirmed babesiosis infection, are experiencing symptoms, and are currently hospitalized. As a Phase 2 trial, this research measures how well the treatment works in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it mentions that some medications might be excluded. It's best to discuss your current medications with the trial team to see if any are not allowed.

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

Research has shown that tafenoquine is generally safe for use. Its safety, particularly for preventing malaria, has been tested in several studies. These studies were carefully designed to ensure that neither participants nor researchers knew who received the actual treatment, maintaining fair and unbiased results.

In these studies, tafenoquine was compared to other treatments and was found to be safe for most people, with few experiencing serious side effects. However, like any medication, some individuals might have mild reactions, which are usually manageable and resolve on their own.

While specific information about tafenoquine for treating babesiosis is still being gathered, its current approval for malaria suggests it is likely safe. Prospective trial participants should discuss any concerns with their doctor. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for babesiosis?

Tafenoquine is unique because, unlike the standard treatments for babesiosis, which typically involve antibiotics like atovaquone and azithromycin, it acts as an antiparasitic agent with a different mechanism of action. Researchers are excited about tafenoquine because it's designed to target the parasites directly, which could potentially lead to quicker and more effective results. Moreover, tafenoquine's oral administration over just four days simplifies the treatment regimen compared to the longer courses required for current therapies.

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

Research has shown that tafenoquine shows promise in animal studies as a treatment for infections similar to babesiosis, specifically Babesia microti. In these studies, tafenoquine effectively eliminated the infection. Additionally, one case demonstrated that tafenoquine successfully treated a patient with a weakened immune system who had a recurring form of the disease. However, tafenoquine has not yet been proven effective or approved for treating babesiosis in humans. In this trial, participants in Group 1 will receive tafenoquine, while Group 2 will receive a placebo. Current studies are further investigating its potential benefits. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

Adults hospitalized for babesiosis who can take oral meds, have good vein access for blood draws, and agree to birth control if of reproductive age. They must not join other drug studies simultaneously, be confirmed with Babesia infection showing symptoms, and consent to study requirements.

Inclusion Criteria

Laboratory confirmed infection with Babesia

Must agree not to enroll in another study of an investigational agent prior to completion of the study

Blood hemoglobin ≥ 7 g/dL

Exclusion Criteria

Receipt of any experimental treatment for babesiosis

Positive pregnancy test

I am not on any medication that is not allowed in the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 days

1 visit (in-person)

Treatment

Participants receive either tafenoquine or placebo along with standard-of-care antimicrobial regimen for 4 days

4 days

Daily visits (in-person) during hospitalization

Follow-up

Participants are monitored for sustained clinical resolution and molecular cure

90 days

Periodic follow-up visits

What Are the Treatments Tested in This Trial?

Interventions

• Tafenoquine

Trial Overview The trial tests Tafenoquine (TQ) plus standard care against a placebo plus standard care in patients with babesiosis. It's double-blind (neither doctors nor patients know who gets what), randomized (assigned by chance), at multiple sites, and checks safety and effectiveness.

How Is the Trial Designed?

Group I: Group 1 Active Control 1 Intervention

TQ: 2 x 100 mg TQ tablets orally on Days 1, 2, 3, and 4

Group II: Group 2 Placebo Group 1 Intervention

Placebo: 2 x 100 mg placebo tablets orally on Days 1, 2, 3, and 4

Tafenoquine is already approved in United States for the following indications:

Approved in United States as Arakoda for:

• Malaria
• Prevention of relapse of Plasmodium vivax malaria

Approved in United States as Krintafel for:

• Malaria
• Prevention of relapse of Plasmodium vivax malaria

Who Is Running the Clinical Trial?

60 Degrees Pharmaceuticals LLC

Lead Sponsor

Trials

6

Recruited

760+

Published Research Related to This Trial

Tafenoquine has shown high effectiveness against Babesia microti infections in animal models, suggesting its potential as a treatment option.

In a case study, an immunocompromised patient with a resistant strain of B. microti was successfully treated with tafenoquine, indicating its possible efficacy in challenging cases of babesiosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of tafenoquine to treat a patient with relapsing babesiosis with clinical and molecular evidence of resistance to azithromycin and atovaquone. Marcos, LA., Leung, A., Kirkman, L., et al.[2022]

Tafenoquine was effective in eliminating visible Babesia microti parasites in mouse models, but all mice relapsed except those treated with artesunate, indicating that tafenoquine alone may not be sufficient to prevent relapse.

An immunocompromised patient experienced a relapse of infection after a 46-day tafenoquine treatment, suggesting that longer treatment durations or combination therapies may be necessary for effective management in such patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Failure of an Approximately Six Week Course of Tafenoquine to Completely Eradicate Babesia microti Infection in an Immunocompromised Patient. Prasad, PJ., Wormser, GP.[2022]

Tafenoquine (TQ) demonstrated a strong efficacy in treating Babesia microti infection in SCID mice, completely eliminating detectable parasites and achieving over 90% reduction in parasitemia within 4 days after treatment.

The study found no evidence of drug resistance developing against TQ, suggesting it could be a promising treatment option for B. microti infections in humans, pending further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Could the Drug Tafenoquine Revolutionize Treatment of Babesia microti Infection? Mordue, DG., Wormser, GP.[2020]

Tafenoquine, recently approved for treating Plasmodium vivax malaria, does not show the same neurotoxic effects as older 8-aminoquinoline drugs like pamaquine and plasmocid, based on a review of both non-clinical and clinical literature.

Unlike some older malaria treatments that caused specific neurological damage in Rhesus monkeys and humans, there is no evidence of similar neurotoxicity associated with tafenoquine or primaquine, suggesting they are safer options for malaria treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tafenoquine and primaquine do not exhibit clinical neurologic signs associated with central nervous system lesions in the same manner as earlier 8-aminoquinolines. Berman, J., Brown, T., Dow, G., et al.[2023]

Tafenoquine is an effective oral anti-malarial drug approved for the radical cure of P. vivax malaria and for malaria prophylaxis, demonstrating its dual action against both liver and blood stages of the parasite.

The exact mechanism of tafenoquine's action is not fully understood, but it may involve inhibiting haematin polymerization and inducing mitochondrial dysfunction in the malaria-causing organisms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tafenoquine: First Global Approval. Frampton, JE.[2019]

Citations

1. investors.60degreespharma.com investors.60degreespharma.com/news-releases/news-release-details/60-degrees-pharmaceuticals-selects-icahn-school-medicine-mount

60 Degrees Pharmaceuticals, Inc. Tafenoquine has not been proven to be effective for treatment or prevention of babesiosis and is not approved by the United States Food and Drug ...

2. 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 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8885462/

Use of tafenoquine to treat a patient with relapsing ... Tafenoquine is a highly effective treatment for Babesia microti infections in animal models. An immunocompromised patient infected by a strain of B. microti

4. sec.gov sec.gov/Archives/edgar/data/1946563/000121390024060093/ea020916101ex99-1_60degrees.htm

Press Release of 60 Degrees Pharmaceuticals, Inc. ... Tafenoquine has not been proven to be effective for treatment or prevention of babesiosis and is not approved by the FDA for such an indication.

5. finance.yahoo.com finance.yahoo.com/news/60-degrees-pharmaceuticals-defines-potential-110100760.html

60 Degrees Pharmaceuticals Defines Potential Human ... ... tafenoquine's safety and efficacy in treating humans diagnosed with babesiosis. Data are expected from one or more of these studies in the ...

6. biospace.com biospace.com/press-releases/60-degrees-pharmaceuticals-announces-no-detection-of-babesia-infection-in-first-patient-following-treatment-with-tafenoquine-in-relapsing-babesiosis-study

60 Degrees Pharmaceuticals Announces No Detection of ... The Company's study aims to confirm the high cure rate for tafenoquine in enrolled immunosuppressed patients with relapsing babesiosis, as ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10534932/

Plasma Blood Levels of Tafenoquine following a Single ... Previous studies of mice infected with Babesia microti have shown that a single dose of tafenoquine administered orally is extremely effective ...