60 Degrees Pharmaceuticals and Tulane University Sign Research Agreement to Study Tafenoquine Against Lyme and Bartonella Bacteria
60 Degrees Pharmaceuticals (NASDAQ: SXTP) has entered into a research agreement with Tulane University to study tafenoquine's effectiveness against Borrelia (Lyme disease) and Bartonella bacteria in cell culture. These pathogens, along with Babesia, are known as the "3Bs" commonly found in tick-borne illnesses.
The study aims to evaluate tafenoquine, an FDA-approved antimalarial drug marketed as ARAKODA®, for potential treatment of co-infections in babesiosis patients. Currently, tafenoquine is undergoing babesiosis trials at several sites. The drug's safety for malaria prophylaxis has been validated through six randomized, controlled trials lasting up to 12 months, though it remains unapproved for treating babesiosis, Borrelia, or Bartonella infections.
60 Degrees Pharmaceuticals (NASDAQ: SXTP) ha stipulato un accordo di ricerca con la Università di Tulane per studiare l'efficacia della tafenoquina contro i batteri Borrelia (responsabili della malattia di Lyme) e Bartonella in colture cellulari. Questi patogeni, insieme a Babesia, sono conosciuti come le "3B" comunemente associate alle malattie trasmesse dalle zecche.
Lo studio mira a valutare la tafenoquina, un farmaco antimalarico approvato dalla FDA e commercializzato come ARAKODA®, per il possibile trattamento delle co-infezioni nei pazienti affetti da babesiosi. Attualmente, la tafenoquina è in fase di sperimentazione per la babesiosi in diversi centri. La sicurezza del farmaco per la profilassi della malaria è stata confermata da sei studi randomizzati e controllati della durata fino a 12 mesi, anche se non è ancora approvato per il trattamento della babesiosi, né delle infezioni da Borrelia o Bartonella.
60 Degrees Pharmaceuticals (NASDAQ: SXTP) ha firmado un acuerdo de investigación con la Universidad de Tulane para estudiar la efectividad de la tafenoquina contra las bacterias Borrelia (enfermedad de Lyme) y Bartonella en cultivos celulares. Estos patógenos, junto con Babesia, son conocidos como las "3B" comúnmente asociadas a enfermedades transmitidas por garrapatas.
El estudio tiene como objetivo evaluar la tafenoquina, un medicamento antipalúdico aprobado por la FDA y comercializado como ARAKODA®, para el posible tratamiento de coinfecciones en pacientes con babesiosis. Actualmente, la tafenoquina se encuentra en ensayos para babesiosis en varios sitios. La seguridad del fármaco para la profilaxis de la malaria ha sido validada mediante seis ensayos aleatorizados y controlados de hasta 12 meses, aunque aún no está aprobado para tratar la babesiosis ni las infecciones por Borrelia o Bartonella.
60 Degrees Pharmaceuticals (NASDAQ: SXTP)는 튤레인 대학교와 연구 협약을 체결하여 보렐리아(라임병) 및 바르토넬라 박테리아에 대한 타페노퀸의 효능을 세포 배양에서 연구하고 있습니다. 이 병원체들은 바베시아와 함께 진드기 매개 질환에서 흔히 발견되는 '3B'로 알려져 있습니다.
이번 연구는 FDA 승인 항말라리아제인 ARAKODA®로 판매되는 타페노퀸을 바베시아증 환자의 공동 감염 치료 가능성을 위해 평가하는 것을 목표로 합니다. 현재 타페노퀸은 여러 기관에서 바베시아증 임상 시험 중입니다. 이 약물은 최대 12개월 동안 진행된 6건의 무작위 대조 시험을 통해 말라리아 예방 안전성이 입증되었으나, 바베시아증, 보렐리아 또는 바르토넬라 감염 치료제로는 아직 승인받지 못했습니다.
60 Degrees Pharmaceuticals (NASDAQ : SXTP) a conclu un accord de recherche avec l'Université Tulane pour étudier l'efficacité de la tafénoquine contre les bactéries Borrelia (maladie de Lyme) et Bartonella en culture cellulaire. Ces agents pathogènes, avec Babesia, sont connus sous le nom des « 3B » couramment présents dans les maladies transmises par les tiques.
L'étude vise à évaluer la tafénoquine, un médicament antipaludique approuvé par la FDA et commercialisé sous le nom de ARAKODA®, comme traitement potentiel des co-infections chez les patients atteints de babésiose. Actuellement, la tafénoquine fait l'objet d'essais cliniques pour la babésiose dans plusieurs centres. La sécurité du médicament pour la prophylaxie du paludisme a été validée lors de six essais randomisés contrôlés d'une durée allant jusqu'à 12 mois, bien qu'il ne soit pas encore approuvé pour le traitement de la babésiose, ni des infections à Borrelia ou Bartonella.
60 Degrees Pharmaceuticals (NASDAQ: SXTP) hat eine Forschungsvereinbarung mit der Tulane University geschlossen, um die Wirksamkeit von Tafenoquin gegen Borrelia (Lyme-Borreliose) und Bartonella-Bakterien in Zellkulturen zu untersuchen. Diese Erreger, zusammen mit Babesien, werden als die "3Bs" bezeichnet, die häufig bei durch Zecken übertragenen Krankheiten vorkommen.
Ziel der Studie ist es, Tafenoquin, ein von der FDA zugelassenes Malariamedikament, das unter dem Namen ARAKODA® vermarktet wird, als potenzielle Behandlung von Co-Infektionen bei Babesiose-Patienten zu evaluieren. Derzeit wird Tafenoquin an mehreren Standorten in Babesiose-Studien getestet. Die Sicherheit des Medikaments zur Malariaprophylaxe wurde in sechs randomisierten, kontrollierten Studien mit einer Dauer von bis zu 12 Monaten bestätigt, jedoch ist es noch nicht für die Behandlung von Babesiose, Borrelia- oder Bartonella-Infektionen zugelassen.
- Research partnership with prestigious Tulane University established
- Potential expansion of tafenoquine's applications to treat widespread tick-borne diseases
- Existing safety profile already established through multiple clinical trials for malaria use
- Tafenoquine not yet proven effective for treating Lyme disease or Bartonella
- FDA approval for new indications will require extensive additional testing
Insights
60 Degrees expands tafenoquine research to Lyme and Bartonella bacteria, potentially broadening its market beyond malaria prophylaxis.
This research agreement between 60 Degrees Pharmaceuticals and Tulane University represents a strategic expansion of tafenoquine's potential applications beyond its current FDA-approved indication for malaria prophylaxis (ARAKODA®). The study will specifically evaluate the drug's activity against Borrelia (causing Lyme disease) and Bartonella bacteria in cell culture—two of the "3Bs" pathogens commonly associated with tick-borne illnesses.
The timing is noteworthy as tafenoquine is already undergoing trials for babesiosis (the third "B"), suggesting a comprehensive approach to addressing complex tick-borne infections. This aligns with clinical observations that post-treatment Lyme disease (PTLD) may be complicated by co-infections with Babesia and Bartonella, which cause overlapping symptoms.
From a market perspective, tick-borne diseases represent a growing opportunity due to climate change expanding tick habitats and increasing infection rates. The CDC estimates approximately 476,000 Americans are diagnosed and treated for Lyme disease annually, with limited treatment options for persistent cases. If tafenoquine demonstrates efficacy against multiple tick-borne pathogens, it could potentially address a significant unmet clinical need and expand 60 Degrees' market positioning substantially.
However, this research is still at the preliminary cell culture stage, and the press release explicitly states tafenoquine "has not been proven effective" for these conditions. Investors should recognize that successful in vitro studies would still require extensive clinical trials before any potential FDA approval for these new indications.
- Study will evaluate activity of tafenoquine against vector-borne pathogens, Borrelia (Lyme disease) and Bartonella in cell culture
- Borrelia and Bartonella, together with Babesia, represent the "3Bs," pathogens most often present in individuals with tick-borne illness such as Lyme disease
WASHINGTON, July 17, 2025 (GLOBE NEWSWIRE) -- 60 Degrees Pharmaceuticals, Inc. (NASDAQ: SXTP; SXTPW) (“60 Degrees” or the “Company”), a pharmaceutical company focused on developing new medicines for infectious diseases, today announced its entry into a sponsored research agreement with Tulane University to evaluate activity of tafenoquine against the vector-borne bacteria, Borrelia (Lyme disease) and Bartonella, in cell culture. Together with Babesia, these three pathogens are known as the “3Bs” in the Lyme disease community.
Acute Lyme disease (Borreliosis) is caused by Borrelia spp. infection, which may also trigger a condition known as post-treatment Lyme disease (PTLD). Prescribers hypothesize that recovery from PTLD is hindered by the ongoing presence of low levels of Babesia and Bartonella spp. in the body, either of which, separately, may cause persistent illness with overlapping symptoms.
“The purpose of this study is to gain a better understanding of these rapidly spreading tick-borne diseases for which there is a growing unmet need for effective, approved treatments,” said Chief Executive Officer of 60 Degrees Pharma, Geoff Dow. “Tafenoquine continues to perform well in babesiosis trials currently underway in several sites. The Tulane University study will help further elucidate tafenoquine’s potential for treating co-infections in babesiosis patients.”
Tafenoquine is an 8-aminoquinoline antimalarial drug 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 six separate randomized, double-blind, active comparator or placebo-controlled trials for durations of up to twelve months.
Tafenoquine has not been proven to be effective for treatment or prevention of babesiosis or Borrelia or Bartonella and is not approved by the U.S. Food and Drug Administration for such an indication.
About ARAKODA® (tafenoquine)
Tafenoquine was discovered by Walter Reed Army Institute of Research. It 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, offers the advantage of less frequent dosing for the prophylaxis of 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 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 (ALT), 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 Contacts:
Sheila A. Burke
SheilaBurke-consultant@60degreespharma.com
(484) 667-6330
Investor Contact:
Patrick Gaynes
patrickgaynes@60degreespharma.com
FAQ
What is the purpose of SXTP's research agreement with Tulane University?
Is tafenoquine currently approved for treating Lyme disease or Bartonella infections?
What are the '3Bs' mentioned in SXTP's research announcement?
What is the current safety profile of SXTP's tafenoquine?
How does this research relate to SXTP's ongoing babesiosis trials?
