60 Degrees Pharmaceuticals Announces No Detection of Babesia Infection in First Patient Following Treatment with Tafenoquine in Relapsing Babesiosis Study
60 Degrees Pharmaceuticals (NASDAQ: SXTP) reported that the first patient completing its expanded access study of ARAKODA® (tafenoquine) for relapsing babesiosis tested negative for Babesia by both a Mayo Clinic RT-PCR and an FDA-licensed RNA amplification assay that is described as at least 100x more sensitive than standard RT-PCR.
On October 3, 2025 the company submitted a Breakthrough Therapy request to FDA and plans a Type B meeting in early 2026 to discuss requirements for a supplementary NDA; remaining patients are expected to finish between January and October 2026 and clinical data are expected in second half of 2026.
60 Degrees Pharmaceuticals (NASDAQ: SXTP) ha riportato che il primo paziente che ha completato lo studio di accesso esteso di ARAKODA® (tafenoquina) per babesiosi ricorrente è risultato negativo per Babesia sia dal RT-PCR della Mayo Clinic sia da un test di amplificazione dell'RNA autorizzato dalla FDA, descritto come almeno 100x più sensibile rispetto al RT-PCR standard.
Il 3 ottobre 2025 l'azienda ha presentato una richiesta di terapia breakthrough alla FDA e pianifica un incontro di tipo B all'inizio del 2026 per discutere i requisiti per una NDA supplementare; i restanti pazienti dovrebbero terminare tra gennaio e ottobre 2026 e i dati clinici sono previsti nella seconda metà del 2026.
60 Degrees Pharmaceuticals (NASDAQ: SXTP) informó que el primer paciente que completó su estudio de acceso expandido de ARAKODA® (tafenoquina) para babesiosis recidivante dio negativo para Babesia tanto por RT-PCR de Mayo Clinic como por un ensayo de amplificación de ARN autorizado por la FDA, descrito como al menos 100x más sensible que el RT-PCR estándar.
El 3 de octubre de 2025 la empresa presentó una solicitud de terapia de avances (Breakthrough Therapy) a la FDA y planea una reunión de Tipo B en principios de 2026 para discutir los requisitos de una NDA suplementaria; se espera que los pacientes restantes terminen entre enero y octubre de 2026 y se esperan los datos clínicos en la segunda mitad de 2026.
60 Degrees Pharmaceuticals (NASDAQ: SXTP)는 ARAKODA® (tafenoquine)의 재발성 베이보시스에 대한 확장 접근 연구를 완료한 첫 번째 환자가 Mayo Clinic RT-PCR와 FDA 허가 RNA 증폭 검사 모두에서 Babesia에 대해 음성으로 판정되었으며, 이는 표준 RT-PCR보다 최소 100배 더 민감하다고 설명되었다고 보고했다.
2025년 10월 3일, 회사는 FDA에 Breakthrough Therapy 요청을 제출했고, 2026년 초에 Type B 회의를 계획하여 보충 NDA의 요건을 논의할 예정이며, 남은 환자는 2026년 1월에서 10월 사이에 완료될 것으로 예상되며 임상 데이터는 2026년 하반기에 예정되어 있다.
60 Degrees Pharmaceuticals (NASDAQ: SXTP) a annoncé que le premier patient ayant terminé son étude d'accès élargi de ARAKODA® (tafénoquine) pour la babésiose récurrente a été testé négatif pour Babesia tant par RT-PCR Mayo Clinic que par un test d’amplification d’ARN autorisé par la FDA, décrit comme au moins 100 fois plus sensible que le RT-PCR standard.
Le 3 octobre 2025, la société a soumis une demande de Thérapie révolutionnaire à la FDA et prévoit une réunion de Type B au début de 2026 pour discuter des exigences d’un NDA supplémentaire; les patients restants devraient terminer entre janvier et octobre 2026 et les données cliniques sont attendues dans la deuxième moitié de 2026.
60 Degrees Pharmaceuticals (NASDAQ: SXTP) berichtete, dass der erste Patient, der die erweiterte Zugangsstudie von ARAKODA® (Tafenoquin) für rezidivierende Babesiose abgeschlossen hat, sowohl von der Mayo Clinic RT-PCR als auch von einem von der FDA lizenzierten RNA-Amplifikations-Assay negativ auf Babesia getestet wurde, der als mindestens 100-mal empfindlicher als die Standard-RT-PCR beschrieben wird.
Am 3. Oktober 2025 hat das Unternehmen einen Antrag auf Breakthrough Therapy bei der FDA eingereicht und plant ein Type-B-Treffen Anfang 2026, um Anforderungen für eine ergänzende NDA zu besprechen; verbleibende Patienten sollen zwischen Januar und Oktober 2026 fertiggestellt werden, und klinische Daten werden in der zweiten Hälfte von 2026 erwartet.
60 Degrees Pharmaceuticals (NASDAQ: SXTP) ذكرت أن أول مريض أكمل دراستها للوصول الموسع لـ ARAKODA® (tafenoquine) لعلاج البابيزيز المتكرر أظهر نتيجة سلبية لـ Babesia في كل من RT-PCR لعيادة Mayo وبرنامج RNA المعتمد من FDA، الوصف بأنه أكثر حساسية بمقدار 100x من RT-PCR القياسي.
في 3 أكتوبر 2025 قدمت الشركة طلباً لـ العلاج الثوري Breakthrough Therapy لدى FDA وتخطط لاجتماع من النوع B في بدايات 2026 لمناقشة متطلبات NDA التكميلي؛ من المتوقع أن يكمل المرضى المتبقون بين يناير وأكتوبر 2026، وتُتوقع البيانات السريرية في النصف الثاني من 2026.
60 Degrees Pharmaceuticals (NASDAQ: SXTP) 报告称，完成其扩展获取研究的 ARAKODA®（托芬酮啶）用于复发性巴贝斯虫病的首位患者，经 Mayo Clinic 的 RT-PCR 以及 FDA 授权的 RNA 放大检测均对 Babesia 显示阴性，该检测被描述为至少比标准 RT-PCR 敏感性高 100x。
2025年10月3日，该公司向 FDA 提交了 突破性疗法（Breakthrough Therapy）请求，并计划在 2026 年初举行 B 型会议，以讨论补充 NDA 的要求；剩余患者预计在 2026 年 1 月至 10 月之间完成，临床数据预计在 2026 年下半年公布。
- First patient tested negative on both Mayo RT-PCR and RNA assay
- Company submitted a Breakthrough Therapy request on Oct 3, 2025
- RNA amplification test described as at least 100x more sensitive
- Remaining enrollees to complete study between Jan–Oct 2026
- Clinical data expected in the second half of 2026
- Tafenoquine is not FDA-approved for babesiosis treatment
- Only one patient reported negative result to date (early evidence)
Insights
Early clinical signal and regulatory engagement increase program visibility; key milestones due across 2026.
The negative result in the first completed patient uses two molecular assays, including an FDA-licensed, highly sensitive RNA amplification test, which strengthens the factual basis that the ARAKODA® (tafenoquine) regimen can clear detectable parasitemia in an immunosuppressed relapsing babesiosis patient. The study design calls for assessment 60 days after clinical resolution and uses both the Mayo RT-PCR and the higher-sensitivity blood-donation RNA assay, giving the observation methodological weight.
Dependencies and risks include a single-patient data point so far, the open-label expanded-access design, and the fact that tafenoquine is not FDA-approved for babesiosis; broader conclusions require the remaining enrolled patients to complete follow-up between
Watchable items and timing: completion of remaining patient follow-ups through
- Breakthrough Therapy Designation request has been submitted to FDA
- Company to request a Type B meeting with FDA in early 2026 to discuss requirements for a supplementary New Drug Application (sNDA)
- Results obtained using highest sensitivity test available; licensed by FDA for blood donation screening
- Remaining enrolled patients will complete the study between January and October 2026
- Study intended to confirm the high cure rate for tafenoquine in immunosuppressed patients with relapsing babesiosis, as reported by Yale in a 2024 publication
WASHINGTON, Oct. 15, 2025 (GLOBE NEWSWIRE) -- 60 Degrees Pharmaceuticals, Inc. (NASDAQ: SXTP; SXTPW) (“60 Degrees” or the “Company”), a pharmaceutical company focused on developing new medicines for vector-borne disease, today announced that the first patient to have completed the regimen in the Company’s trial of relapsing babesiosis in immunosuppressed patients has tested negative for babesiosis. The trial is an expanded access study of ARAKODA® (tafenoquine) in combination with conventional treatments for relapsing babesiosis (NCT06478641).
Babesiosis is a tick-borne illness caused by Babesia parasites that develop and multiply in red blood cells. Symptoms include fevers, chills, sweats, and fatigue. In severe cases, babesiosis can be life-threatening in elderly and immunosuppressed patients. Incidence of the disease is rapidly rising, particularly in the Northeast. The disease may relapse multiple times in patients with risk factors such as asplenia (no spleen) or individuals who have been administered immunosuppressive drugs. Babesia parasites frequently develop resistance to conventional drugs when they are used persistently to manage disease in such patients.
No U.S. Food and Drug Administration (FDA)-approved treatment or vaccine exists for babesiosis.
The Company’s study aims to confirm the high cure rate for tafenoquine in enrolled immunosuppressed patients with relapsing babesiosis, as reported by Yale in a 2024 Clinical Infectious Diseases publication. It is an open label, expanded access, multi-site study evaluating the safety and efficacy of the ARAKODA® regimen of tafenoquine combined with standard of care medications in patients with risk factors for severe disease with relapsing babesiosis who have previously failed conventional antimicrobial regimens.
Sixty days following clinical resolution and cessation of study drug administration, the study protocol calls for a follow-up visit at which two molecular tests are administered to assess parasite infection status. One test is an RT-PCR from Mayo Clinic. The second is an FDA-approved RNA amplification test used for blood donation screening that is at least 100 times more sensitive than standard commercial RT-PCRs such as the Mayo test. Since blood donation screening using RNA amplification tests commenced in 2020, the number of babesiosis infections contracted through the U.S. blood donation system has declined precipitously.
The first patient in the 60 Degrees expanded access relapsing babesiosis study tested negative for babesiosis infection using both the Mayo and RNA amplification assays.
On October 3, 2025, the Company submitted a Breakthrough Therapy Application to the FDA for use of tafenoquine for treatment of babesiosis patients requiring medical treatment.
The remaining patients now enrolled are anticipated to complete the study between January and October, 2026.
The Company plans to request a Type B meeting with FDA in early 2026 to discuss requirements for a supplementary New Drug Application (sNDA).
Tafenoquine is not currently approved by the FDA for the treatment and prevention of babesiosis. Tafenoquine is approved for malaria prophylaxis in the United States under the product name ARAKODA® (tafenoquine).
Clinical Babesiosis Studies Sponsored by 60 Degrees Pharmaceuticals
Three 60 Degrees Pharmaceuticals-sponsored clinical trials (NCT06478641, NCT06207370, NCT06656351) are underway or planned to evaluate safety and efficacy of tafenoquine in treating humans diagnosed with babesiosis. Data are expected from one or more of these studies second half of 2026 and will be used as part of a planned supplementary New Drug Application (sNDA) submission to the U.S. Food and Drug Administration for babesiosis.
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, 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 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 Contacts:
Sheila A. Burke
SheilaBurke-consultant@60degreespharma.com
(484) 667-6330
Investor Contact:
Patrick Gaynes
patrickgaynes@60degreespharma
A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/aafe096f-fee5-4824-a359-dd3d0a6bc17e
FAQ
What result did 60 Degrees (SXTP) announce for the first patient in the relapsing babesiosis study?
When did 60 Degrees submit a Breakthrough Therapy request to FDA for tafenoquine (SXTP)?
What regulatory meetings does 60 Degrees plan for tafenoquine (SXTP) in 2026?
When are the remaining patients in the SXTP relapsing babesiosis study expected to complete the trial?
How sensitive is the RNA amplification test used in the 60 Degrees babesiosis study?
When does 60 Degrees expect to have clinical data for tafenoquine (SXTP) in babesiosis?
Is tafenoquine currently FDA-approved for treatment of babesiosis (SXTP)?
