60 Degrees Pharmaceuticals Selects Icahn School of Medicine at Mount Sinai as Central Clinical Trial Site for Phase II Study to Evaluate Tafenoquine for Chronic Babesiosis
60 Degrees Pharmaceuticals (NASDAQ: SXTP) has selected the Icahn School of Medicine at Mount Sinai as the central site for a Phase II clinical trial evaluating tafenoquine for chronic babesiosis treatment. The 90-day open-label study will assess the drug's efficacy in treating patients with disabling fatigue lasting at least six months.
The trial will evaluate ARAKODA® (tafenoquine) with a dosing regimen of 2 x 100 mg tablets administered orally for the first four days, followed by weekly doses for 12 weeks. The primary endpoint is fatigue resolution measured using a patient-reported outcome scale. Enrollment is expected to begin in Q4 2025 with completion targeted for Q2 2026.
This study is one of three clinical trials sponsored by 60 Degrees Pharma to evaluate tafenoquine for babesiosis, with data expected in H1 2026. The company plans to submit a New Drug Application (NDA) to the FDA in 2026.
60 Degrees Pharmaceuticals (NASDAQ: SXTP) ha scelto la Icahn School of Medicine at Mount Sinai come centro principale per uno studio clinico di Fase II che valuterà il tafenoquine nel trattamento della babesiosi cronica. Lo studio open-label di 90 giorni esaminerà l'efficacia del farmaco in pazienti con affaticamento debilitante persistente da almeno sei mesi.
Lo studio testerà ARAKODA® (tafenoquine) con un regime posologico di 2 compresse da 100 mg assunte per via orale nei primi quattro giorni, seguite da dosi settimanali per 12 settimane. L'endpoint primario è la risoluzione dell'affaticamento misurata con una scala di outcome riferita dal paziente. Le arruolazioni dovrebbero iniziare nel Q4 2025 e il completamento è previsto per il Q2 2026.
Questa indagine è uno dei tre studi clinici sponsorizzati da 60 Degrees Pharma per valutare il tafenoquine nella babesiosi, con dati attesi nel primo semestre 2026. La società intende presentare una New Drug Application (NDA) alla FDA nel 2026.
60 Degrees Pharmaceuticals (NASDAQ: SXTP) ha seleccionado la Icahn School of Medicine at Mount Sinai como centro principal para un ensayo clínico de fase II que evaluará tafenoquina en el tratamiento de la babesiosis crónica. El estudio abierto de 90 días analizará la eficacia del fármaco en pacientes con fatiga incapacitante durante al menos seis meses.
El ensayo evaluará ARAKODA® (tafenoquina) con un régimen de dos comprimidos de 100 mg por vía oral durante los primeros cuatro días, seguidos de dosis semanales durante 12 semanas. El criterio principal es la resolución de la fatiga medida mediante una escala de resultado informada por el paciente. Se espera que el reclutamiento comience en el Q4 2025 y que la finalización esté prevista para el Q2 2026.
Este estudio es uno de los tres ensayos clínicos patrocinados por 60 Degrees Pharma para evaluar tafenoquina en babesiosis, con datos previstos en el primer semestre de 2026. La compañía planea presentar una New Drug Application (NDA) a la FDA en 2026.
60 Degrees Pharmaceuticals (NASDAQ: SXTP)는 만성 바베시아증 치료를 위한 타페노퀸의 임상 2상 시험의 중심 연구기관으로 Icahn School of Medicine at Mount Sinai를 선정했습니다. 90일 공개 라벨 연구는 최소 6개월 이상 지속되는 심각한 피로를 호소하는 환자들에서 약물의 유효성을 평가합니다.
시험은 ARAKODA® (타페노퀸)을 첫 4일간 경구로 100 mg 정제 2정 복용하고, 이후 12주 동안 주간 투여하는 투약 요법으로 평가합니다. 주된 평가변수는 환자 보고 결과 척도로 측정한 피로 해소입니다. 등록은 Q4 2025에 시작될 예정이며 완료 목표는 Q2 2026입니다.
이 연구는 60 Degrees Pharma가 후원하는 타페노퀸 관련 세 건의 임상시험 중 하나로, 데이터는 2026년 상반기에 도출될 것으로 예상됩니다. 회사는 2026년에 FDA에 New Drug Application (NDA)을 제출할 계획입니다.
60 Degrees Pharmaceuticals (NASDAQ: SXTP) a choisi la Icahn School of Medicine at Mount Sinai comme site principal pour un essai clinique de phase II évaluant le tafenoquine dans le traitement de la babésiose chronique. L'étude ouverte de 90 jours évaluera l'efficacité du médicament chez des patients présentant une fatigue invalidante depuis au moins six mois.
L'essai portera sur ARAKODA® (tafenoquine) avec un schéma posologique de 2 comprimés de 100 mg pris par voie orale pendant les quatre premiers jours, puis des doses hebdomadaires pendant 12 semaines. Le critère principal est la disparition de la fatigue mesurée par une échelle d'évaluation rapportée par le patient. Le recrutement devrait débuter au T4 2025 (Q4 2025) et l'achèvement est visé pour le T2 2026 (Q2 2026).
Cette étude est l'une des trois essais cliniques parrainés par 60 Degrees Pharma pour évaluer le tafenoquine dans la babésiose, des données étant attendues au premier semestre 2026. La société prévoit de déposer une New Drug Application (NDA) auprès de la FDA en 2026.
60 Degrees Pharmaceuticals (NASDAQ: SXTP) hat die Icahn School of Medicine at Mount Sinai als Zentrumsstandort für eine Phase-II-Studie ausgewählt, die Tafenoquin zur Behandlung der chronischen Babesiose untersucht. Die 90-tägige Open-Label-Studie wird die Wirksamkeit des Medikaments bei Patienten mit mindestens sechs Monate andauernder, stark einschränkender Müdigkeit bewerten.
Untersucht wird ARAKODA® (Tafenoquin) mit einem Dosierungsschema von 2 x 100 mg Tabletten oral an den ersten vier Tagen, gefolgt von wöchentlichen Dosen über 12 Wochen. Der primäre Endpunkt ist die Beseitigung der Müdigkeit, gemessen anhand einer vom Patienten berichteten Outcome-Skala. Die Rekrutierung soll im Q4 2025 beginnen und der Abschluss ist für das Q2 2026 geplant.
Diese Studie ist eine von drei klinischen Prüfungen, die 60 Degrees Pharma zur Bewertung von Tafenoquin bei Babesiose sponsert; Daten werden im ersten Halbjahr 2026 erwartet. Das Unternehmen plant, 2026 einen New Drug Application (NDA)-Antrag bei der FDA einzureichen.
- Company secured prestigious Icahn School of Medicine at Mount Sinai as central trial site
- Trial addresses an unmet medical need with no current FDA-approved treatment for chronic babesiosis
- Company has three ongoing/planned clinical trials for babesiosis indication
- Clear timeline for potential NDA submission to FDA in 2026
- Tafenoquine is not yet proven effective for babesiosis treatment
- Extended timeline to potential approval with data not expected until H1 2026
Insights
60 Degrees Pharma advances tafenoquine's potential by partnering with Mount Sinai for a Phase II chronic babesiosis trial addressing an unmet medical need.
60 Degrees Pharmaceuticals has selected the prestigious Icahn School of Medicine at Mount Sinai as the central clinical trial site for their Phase II study evaluating tafenoquine in treating chronic babesiosis. This strategic partnership leverages Mount Sinai's expertise in tick-borne illnesses and access to a relevant patient population.
The open-label study (NCT06656351) will assess a 90-day treatment regimen of ARAKODA® (tafenoquine) in patients with chronic babesiosis, defined as those experiencing disabling fatigue for at least six months with laboratory confirmation. The primary endpoint focuses on resolution of fatigue using a patient-reported outcome measure at Day 90 compared to baseline.
This trial holds particular significance as no FDA-approved treatment currently exists for chronic babesiosis, a debilitating tick-borne illness. The study employs a specific dosing regimen: 2×100mg tablets administered orally with food on Days 1-4, then weekly from Day 11 through Day 89.
This study represents one of three clinical trials in 60 Degrees Pharma's babesiosis program. Data from these trials, expected in H1 2026, will support a planned New Drug Application to the FDA later that year. While tafenoquine is already FDA-approved for malaria prophylaxis (as ARAKODA®), this represents a potential label expansion into a new indication.
The company's strategic timeline appears well-structured, with enrollment expected to begin in Q4 2025 and complete by Q2 2026. If successful, this development program could address an important unmet medical need while potentially expanding the commercial opportunities for 60 Degrees Pharmaceuticals' lead asset.
- 90-day trial measuring change in general fatigue in chronic babesiosis patients
- Enrollment expected to commence Q4 2025 and to be completed by Q2 2026
- Site has clinical expertise in infectious disease trials and access to a robust patient population with tick-borne illness, including chronic babesiosis
- No FDA-approved treatment exists for chronic babesiosis, a debilitating illness
WASHINGTON, Aug. 19, 2025 (GLOBE NEWSWIRE) -- 60 Degrees Pharmaceuticals, Inc. (NASDAQ: SXTP; SXTPW) (“60 Degrees Pharma” or the “Company”), a pharmaceutical company focused on developing new medicines for vector-borne disease, announced today it has signed a clinical trial agreement with the Icahn School of Medicine at Mount Sinai in New York City as the central site for a Phase II clinical study of tafenoquine in treating chronic babesiosis.
For the purposes of the study, chronic babesiosis is defined as a patient with disabling fatigue of at least six months duration, with other symptoms, and laboratory confirmation of, babesiosis.
The open-label study (NCT06656351) will evaluate the efficacy and safety of the ARAKODA® (tafenoquine) regimen over 90 days, treating patients with a presumptive diagnosis of chronic babesiosis. The primary endpoint will be resolution of fatigue assessed using a patient reported outcome measure (the multi-dimensional fatigue inventory general fatigue subscale) at Day 90 compared with baseline. Participants will have experienced significant functional impairment for at least six months. 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.
Tafenoquine is approved for malaria prophylaxis in the United States under the product name ARAKODA®. 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.
“We are pleased to welcome the Icahn School of Medicine at Mount Sinai research team into the 60 Degrees Pharma tafenoquine for babesiosis clinical trial program,” said 60 Degrees Pharmaceuticals, Inc. Chief Executive Officer, Geoff Dow, PhD. “They bring deep expertise and skill in researching tick-borne illnesses, along with a focus on supporting the development of novel therapies to meet the critical unmet needs of patients with chronic disease.”
Clinical Babesiosis Studies Sponsored by 60 Degrees Pharmaceuticals
Three 60 Degrees Pharmaceuticals-sponsored clinical trials (NCT06478641, NCT06207370, NCT06656351) are underway or planned to evaluate tafenoquine’s safety and efficacy in treating humans diagnosed with babesiosis. Data are expected from one or more of these studies in the first half of 2026 and will be used as part of a planned New Drug Application (NDA) submission to the U.S. Food and Drug Administration for babesiosis, anticipated in 2026.
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 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 commercializing new medicines for the treatment and prevention of vector-borne disease. The Company achieved U.S. Food and Drug Administration approval of Its lead product, ARAKODA® (tafenoquine), for malaria prevention, in 2018. ARAKODA is commercially available in the U.S. and Australia. 60 Degrees Pharmaceuticals, Inc. also collaborates with prominent research and academic organizations in the U.S. and Australia. 60 Degrees Pharmaceuticals, Inc. is headquartered in Washington, D.C., with a 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
FAQ
What is the purpose of SXTP's Phase II clinical trial at Mount Sinai?
When will 60 Degrees Pharmaceuticals (SXTP) complete enrollment for the babesiosis trial?
What is the dosing regimen for tafenoquine in SXTP's chronic babesiosis trial?
How many clinical trials is 60 Degrees Pharmaceuticals conducting for babesiosis?
When does SXTP plan to submit the New Drug Application (NDA) for babesiosis?
