First Patient Enrolled in 60 Degrees Pharmaceuticals Clinical Trial of Tafenoquine for Babesiosis at Tufts Medical Center; First and Only Study of Its Kind
60 Degrees Pharmaceuticals (SXTP) has enrolled the first patient in a groundbreaking clinical trial at Tufts Medical Center to evaluate the efficacy and safety of tafenoquine in treating human babesiosis. The randomized, double-blind, placebo-controlled study aims to enroll 24-33 participants to assess time to sustained clinical resolution and molecular cure using an FDA-approved nucleic acid test. Tafenoquine, already approved for malaria prophylaxis under the name ARAKODA, has been designated as an orphan drug by the FDA for this new indication. Babesiosis, a tick-borne disease, poses significant health risks, particularly for the elderly and immunosuppressed.
- First patient enrolled in the world's first clinical trial of tafenoquine for babesiosis.
- Study aims to enroll 24-33 participants at Tufts Medical Center.
- Tafenoquine has been designated as an orphan drug by the FDA.
- Tafenoquine has not yet been proven effective for treating babesiosis.
- Tafenoquine is not approved by the FDA for treating babesiosis.
Insights
The initiation of a clinical trial to evaluate the efficacy and safety of tafenoquine for the treatment of babesiosis is indeed noteworthy. Clinical trials, especially randomized, double-blind, placebo-controlled ones, are the gold standard for assessing new therapeutic interventions. This trial seeks to determine whether tafenoquine, already approved for malaria prophylaxis, can be effective for babesiosis, an often overlooked tick-borne disease that can be severe in certain populations.
Given that this is the first and only trial of its kind, it can potentially be a significant step forward in the treatment landscape for babesiosis. If successful, it could lead to FDA approval for a new indication for tafenoquine, thus broadening its market and utility. Additionally, the orphan drug designation by the FDA offers financial incentives and potential market exclusivity upon approval, which is advantageous for the company.
However, it is important to remember that this is an early-stage trial with a small sample size (24-33 participants). The results, while potentially promising, will need further validation through subsequent phases involving larger populations to ensure efficacy and safety.
From a market perspective, the enrollment of the first patient in this clinical trial can create a positive outlook for 60 Degrees Pharmaceuticals. The company's stock (NASDAQ: SXTP; SXTPW) may see a surge in investor interest due to the potential of tafenoquine to address an unmet medical need in babesiosis treatment. Investors often respond positively to the initiation of clinical trials, especially those that could lead to new indications for existing drugs.
The orphan drug designation is another strategic win. Orphan drugs usually enjoy market exclusivity upon approval, which can be a significant market differentiator, potentially allowing the company to charge premium prices. The existing approval of tafenoquine for malaria prophylaxis also provides a safety profile that can streamline the regulatory process if the drug proves effective for babesiosis.
However, investors should be cautious about the inherent risks in clinical trials. While the potential for market expansion is significant, the small sample size and early stage of the trial mean results are still uncertain. The company's ability to secure further partnerships with other university hospitals could also impact the trial's progress and outcomes.
- The efficacy and safety of tafenoquine in treating human babesiosis will be evaluated in a randomized, double-blind, placebo-controlled trial conducted at Tufts Medical Center in Boston.
- Endpoints are time to sustained clinical resolution of symptoms of babesiosis, and molecular cure as determined by an FDA-approved nucleic acid test (NAT).
- Study is the world’s first and only clinical trial evaluating tafenoquine in human babesiosis patients.
WASHINGTON, June 27, 2024 (GLOBE NEWSWIRE) -- 60 Degrees Pharmaceuticals, Inc. (NASDAQ: SXTP; SXTPW) (the “Company” or 60 Degrees Pharmaceuticals), a pharmaceutical company focused on developing new medicines for infectious diseases, announced that the first patient has been enrolled in a randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of tafenoquine in treating babesiosis in humans. The patient was enrolled at Tufts Medical Center in Boston.
The study will enroll at least 24, and as many as 33 people. It is the world's first and only clinical trial evaluating the efficacy and safety of tafenoquine in human patients who have been diagnosed with acute babesiosis.
"With the first patient now enrolled in this groundbreaking clinical study, we have moved into a key phase of development with tafenoquine as a potential new treatment option in treating babesiosis,” said Geoff Dow, PhD, chief executive officer at 60 Degrees Pharmaceuticals. “Given both the growing prevalence of babesiosis and the difficulty of quickly differentiating it from other illnesses seen in the clinic, we anticipate the numbers of people hospitalized with this serious tick-borne illness will continue to rise over time. In such cases, babesiosis can certainly become life-threatening. Our goal is for tafenoquine to play an important role in safely and effectively resolving babesiosis in those patients.”
Babesiosis is a steadily emerging, tick-borne disease transmitted through the bite of the black-legged (deer) tick, the vector that spreads Lyme disease. An orphan disease, babesiosis may be life-threatening in elderly and immunosuppressed patients.
The Company is in discussions with other prominent university hospitals to participate in the tafenoquine for babesiosis study.
Tafenoquine is approved for malaria prophylaxis in the United States under the product name ARAKODA®. The safety of the approved regimen of tafenoquine for malaria prophylaxis has been assessed in five separate randomized, double-blind, active comparator or placebo-controlled trials for durations of up to six months. Tafenoquine has not been proven to be effective for treatment or prevention of babesiosis and is not approved by the U.S. Food and Drug Administration for such an indication.
60 Degrees Pharma recently announced tafenoquine has been designated as an orphan drug by the U.S. Food and Drug Administration.
About the Tafenoquine in Babesiosis Study
The study is a randomized, double-blind, placebo-controlled trial enrolling patients in multiple sites in the Northeast U.S. comparing the safety and efficacy of tafenoquine versus placebo in patients hospitalized for babesiosis, i.e., acute cases. The two main study endpoints will be time to sustained clinical resolution of symptoms of babesiosis and molecular cure as determined by an FDA-approved nucleic acid test (NAT). At least 24, and as many as 33 patients, will be recruited before an interim analysis is conducted. Sufficient enrollment capacity is planned to allow all these patients to be recruited during the 2024 tick season (June to September) if caseload is high. The interim analysis will include both a test of significance as well as size re-estimation to allow additional recruitment if required. The study will be conducted at three hospitals in the northeastern United States.
About ARAKODA® (tafenoquine)
Tafenoquine was discovered by Walter Reed Army Institute of Research. Tafenoquine was approved for malaria prophylaxis in 2018 in the United States as ARAKODA® and in Australia as KODATEF®. Both were commercially launched in 2019 and are currently distributed through pharmaceutical wholesaler networks in each respective country. They are available at retail pharmacies as a prescription-only malaria prevention drug. According to the Centers for Disease Control and Prevention, the long terminal half-life of tafenoquine, which is approximately 16 days, may offer potential advantages in less-frequent dosing for prophylaxis for malaria. ARAKODA is not suitable for everyone, and patients and prescribers should review the Important Safety Information below. Individuals at risk of contracting malaria are prescribed ARAKODA 2 x 100 mg tablets once per day for three days (the loading phase) prior to travel to an area of the world where malaria is endemic, 2 x 100 mg tablets weekly for up to six months during travel, then 2 x 100 mg in the week following travel.
ARAKODA® (tafenoquine) Important Safety Information:
ARAKODA® is an antimalarial indicated for the prophylaxis of malaria in patients aged 18 years of age and older.
Contraindications
ARAKODA® should not be administered to:
- Glucose-6-phosphate dehydrogenase (“G6PD”) deficiency or unknown G6PD status;
- Breastfeeding by a lactating woman when the infant is found to be G6PD deficient or if
- G6PD status is unknown;
- Patients with a history of psychotic disorders or current psychotic symptoms; or
- Known hypersensitivity reactions to tafenoquine, other 8-aminoquinolines, or any component of ARAKODA®.
Warnings and Precautions
Hemolytic Anemia: G6PD testing must be performed before prescribing ARAKODA® due to the risk of hemolytic anemia. Monitor patients for signs or symptoms of hemolysis.
G6PD Deficiency in Pregnancy or Lactation: ARAKODA® may cause fetal harm when administered to a pregnant woman with a G6PD-deficient fetus. ARAKODA® is not recommended during pregnancy. A G6PD-deficient infant may be at risk for hemolytic anemia from exposure to ARAKODA® through breast milk. Check infant’s G6PD status before breastfeeding begins.
Methemoglobinemia: Asymptomatic elevations in blood methemoglobin have been observed. Initiate appropriate therapy if signs or symptoms of methemoglobinemia occur.
Psychiatric Effects: Serious psychotic adverse reactions have been observed in patients with a history of psychosis or schizophrenia, at doses different from the approved dose. If psychotic symptoms (hallucinations, delusions, or grossly disorganized thinking or behavior) occur, consider discontinuation of ARAKODA® therapy and evaluation by a mental health professional as soon as possible.
Hypersensitivity Reactions: Serious hypersensitivity reactions have been observed with administration of ARAKODA®. If hypersensitivity reactions occur, institute appropriate therapy.
Delayed Adverse Reactions: Due to the long half-life of ARAKODA® (approximately 17 days), psychiatric effects, hemolytic anemia, methemoglobinemia, and hypersensitivity reactions may be delayed in onset and/or duration.
Adverse Reactions: The most common adverse reactions (incidence greater than or equal to 1 percent) were: headache, dizziness, back pain, diarrhea, nausea, vomiting, increased alanine aminotransferase, motion sickness, insomnia, depression, abnormal dreams, and anxiety.
Drug Interactions
Avoid co-administration with drugs that are substrates of organic cation transporter-2 or multidrug and toxin extrusion transporters.
Use in Specific Populations
Lactation: Advise women not to breastfeed a G6PD-deficient infant or infant with unknown G6PD status during treatment and for 3 months after the last dose of ARAKODA®.
To report SUSPECTED ADVERSE REACTIONS, contact 60 Degrees Pharmaceuticals, Inc. at 1- 888-834-0225 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. The full prescribing information of ARAKODA® is located here.
About 60 Degrees Pharmaceuticals, Inc.
60 Degrees Pharmaceuticals, Inc., founded in 2010, specializes in developing and marketing new medicines for the treatment and prevention of infectious diseases that affect the lives of millions of people. 60 Degrees Pharmaceuticals, Inc. achieved FDA approval of its lead product, ARAKODA® (tafenoquine), for malaria prevention, in 2018. 60 Degrees Pharmaceuticals, Inc. also collaborates with prominent research organizations in the U.S., Australia, and Singapore. The 60 Degrees Pharmaceuticals, Inc. mission has been supported through in-kind funding from the U.S. Department of Defense and private institutional investors including Knight Therapeutics Inc., a Canadian-based pan-American specialty pharmaceutical company. 60 Degrees Pharmaceuticals, Inc. is headquartered in Washington D.C., with a majority-owned subsidiary in Australia. Learn more at www.60degreespharma.com.
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Media Contact:
Sheila A. Burke
SheilaBurke-consultant@60degreespharma.com
(484) 667-6330
Investor Contact:
Patrick Gaynes
patrickgaynes@60degreespharma.com
(310) 989-5666
FAQ
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