IRB approved Phase II study for tafenoquine to treat chronic babesiosis; enrollment to start Q3 2025.
Quiver AI Summary
60 Degrees Pharmaceuticals, Inc. announced the approval of an Investigational Review Board (IRB) for a Phase II clinical study aimed at evaluating the efficacy and safety of tafenoquine, marketed as ARAKODA®, for treating patients with chronic babesiosis. The open-label study, which will enroll patients who have suffered significant functional impairment for at least six months, is set to begin in Q3 2025. This is particularly timely as babesiosis cases rise in the U.S., especially in the Northeast. The objective is to address the lack of approved treatments for chronic babesiosis, which poses significant health risks, especially to vulnerable populations. Tafenoquine is currently approved for malaria prophylaxis but has not yet been proven safe or effective for babesiosis. The study is supported by the U.S. Army Medical & Materiel Development Activity.
Potential Positives
- IRB approval received for a Phase II clinical study, validating the research direction and potential for tafenoquine as a treatment option.
- Enrollment expected to commence in Q3 2025, indicating the company is on track for future clinical progress.
- Estimate of over 400,000 patients in the addressable market for tafenoquine, highlighting significant commercial potential.
Potential Negatives
- Potential delays in patient enrollment for the clinical study, expected to start in Q3 2025, may indicate challenges in the company’s operational timelines.
- Previously, tafenoquine has not been proven effective for babesiosis, creating uncertainty around the outcomes of this new clinical trial.
- The substantial doubt regarding the company's ability to continue on a going-concern basis, as indicated in the cautionary statements, raises concerns about its financial stability and future operations.
FAQ
What is the purpose of the tafenoquine study?
The study aims to evaluate the efficacy and safety of tafenoquine for patients with chronic babesiosis.
When is patient enrollment expected to begin?
Enrollment for the clinical study is expected to commence in Q3 2025.
What organization approved the clinical study for tafenoquine?
The Investigational Review Board (IRB) has granted approval for the clinical study.
What is chronic babesiosis?
Chronic babesiosis is a tick-borne illness caused by Babesia parasites, leading to severe symptoms and functional impairment.
Is tafenoquine currently approved for treating babesiosis?
No, tafenoquine is not approved by the FDA for the treatment of babesiosis at this time.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
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Full Release
Investigational Review Board (IRB) approval has been granted for the open-label study to evaluate
tafenoquine
for treatment of patients with a presumptive diagnosis of chronic babesiosis in outpatient settings.
Enrollment expected to commence Q3 2025.
WASHINGTON, Jan. 28, 2025 (GLOBE NEWSWIRE) --
60 Degrees Pharmaceuticals, Inc.
(NASDAQ: SXTP; SXTPW) (the “Company”), a pharmaceutical company focused on developing new medicines for infectious diseases, announced today the approval of an Investigational Review Board (IRB) sanctioned
Phase II clinical study
.
The study (NCT06656351) will evaluate the efficacy and safety of the ARAKODA® regimen (
tafenoquine
) over 90 days for treating patients with a presumptive diagnosis of chronic babesiosis. Participants will have experienced significant functional impairment for at least six months. Patient enrollment is expected to begin in Q3 2025.
“As babesiosis continues to emerge in new regions of the U.S., the need to address its impact safely and effectively is also growing,” said 60 Degrees Pharmaceuticals, Inc. Chief Executive Officer, Geoff Dow, PhD. “The chronic phase of babesiosis particularly may prove to be one of the most important areas of study due to the estimated large size of the patient population, the severity and duration of symptoms, and the absence of any approved treatment option available today.”
The Company estimates the total cumulative addressable market through the end of U.S. patent protection in December 2035 for ARAKODA (
tafenoquine
) for babesiosis exceeds 400,000 patients.
About Babesiosis
Babesiosis is a tick-borne illness caused by
Babesia
parasites that develop and multiply in red blood cells. Its symptoms include fevers, chills, sweats, and fatigue, and in severe cases, can be life-threatening threatening in elderly and immunosuppressed patients. Incidence of the disease is rapidly rising, particularly in the Northeast. Transmitted through the bite of the black-legged (deer) tick, the vector that spreads Lyme disease, babesiosis is an orphan disease.
Babesia
infection may persist for at least a year; fatigue is usually the symptom of infection that takes longest to resolve and may be debilitating over the long term in some patients.
About ARAKODA® (tafenoquine)
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 United States Food and Drug Administration for such an indication.
Tafenoquine
was discovered by Walter Reed Army Institute of Research and the current study was funded by the United States Army Medical & Materiel Development Activity.
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 16 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
. The statements contained herein may include prospects, statements of future expectations and other forward-looking statements that are based on management’s current views and assumptions and involve known and unknown risks and uncertainties. Actual results, performance or events may differ materially from those expressed or implied in such forward-looking statements.
Cautionary Note Regarding Forward-Looking Statements
This press release may contain “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward‐looking statements reflect the current view about future events. When used in this press release, the words “anticipate,” “believe,” “estimate,” “expect,” “future,” “intend,” “plan,” or the negative of these terms and similar expressions, as they relate to us or our management, identify forward‐looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and trends, the economy, activities of regulators and future regulations and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Our actual results and financial condition may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause our actual results and financial condition to differ materially from those indicated in the forward-looking statements include, among others, the following: there is substantial doubt as to our ability to continue on a going-concern basis; we might not be eligible for Australian government research and development tax rebates; if we are not able to successfully develop, obtain FDA approval for, and provide for the commercialization of non-malaria prevention indications for
tafenoquine
(ARAKODA® or other regimen) or Celgosivir in a timely manner, we may not be able to expand our business operations; we may not be able to successfully conduct planned clinical trials or patient recruitment in our trials might be slow or negligible; and we have no manufacturing capacity which puts us at risk of lengthy and costly delays of bringing our products to market. More detailed information about the Company and the risk factors that may affect the realization of forward- looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (“SEC”), including the information contained in our Annual Report on Form 10-K filed with the SEC on April 1, 2024, and our subsequent SEC filings. Investors and security holders are urged to read these documents free of charge on the SEC’s website at www.sec.gov. As a result of these matters, changes in facts, assumptions not being realized or other circumstances, the Company’s actual results may differ materially from the expected results discussed in the forward-looking statements contained in this press release. Any forward-looking statement made by us in this press release is based only on information currently available to us and speaks only as of the date on which it is made. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.
Media Contact:
Sheila A. Burke
SheilaBurke-consultant@60degreespharma.com
(484) 667-6330
Investor Contact:
Patrick Gaynes
patrickgaynes@60degreespharma.com
(310) 989-5666
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