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60 Degrees Pharma Announces IRB Approval of Phase II Study to Evaluate Tafenoquine for Chronic Babesiosis

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60 Degrees Pharmaceuticals (NASDAQ: SXTP) has received IRB approval for a Phase II clinical study to evaluate ARAKODA® (tafenoquine) in treating chronic babesiosis. The open-label study (NCT06656351) will assess the drug's efficacy and safety over 90 days in outpatient settings, targeting patients with presumptive chronic babesiosis who have experienced significant functional impairment for at least six months.

Patient enrollment is scheduled to begin in Q3 2025. The company estimates the total cumulative addressable market through December 2035 (U.S. patent protection end) exceeds 400,000 patients. The study aims to address an unmet medical need, as there are currently no approved treatment options for chronic babesiosis, a condition that is emerging in new regions of the U.S.

60 Degrees Pharmaceuticals (NASDAQ: SXTP) ha ricevuto l'approvazione dell'IRB per uno studio clinico di Fase II per valutare ARAKODA® (tafenoquina) nel trattamento della babesiosi cronica. Lo studio open-label (NCT06656351) valuterà l'efficacia e la sicurezza del farmaco per un periodo di 90 giorni in contesti ambulatoriali, rivolgendosi a pazienti con babesiosi cronica presuntiva che hanno subito un significativo peggioramento funzionale per almeno sei mesi.

L'arruolamento dei pazienti è previsto per Q3 2025. L'azienda stima che il mercato indirizzabile cumulativo totale fino a dicembre 2035 (fine della protezione del brevetto negli Stati Uniti) superi 400.000 pazienti. Lo studio mira a soddisfare un bisogno medico non soddisfatto, poiché attualmente non esistono opzioni di trattamento approvate per la babesiosi cronica, una condizione che sta emergendo in nuove regioni degli Stati Uniti.

60 Degrees Pharmaceuticals (NASDAQ: SXTP) ha recibido la aprobación del IRB para un estudio clínico de Fase II para evaluar ARAKODA® (tafenoquina) en el tratamiento de la babesiosis crónica. El estudio abierto (NCT06656351) evaluará la eficacia y seguridad del fármaco durante 90 días en entornos ambulatorios, dirigiéndose a pacientes con babesiosis crónica presunta que han experimentado un deterioro funcional significativo durante al menos seis meses.

Se prevé que la inscripción de pacientes comience en Q3 2025. La empresa estima que el mercado total acumulativo direccionable hasta diciembre de 2035 (fin de la protección de patente en EE. UU.) superará 400,000 pacientes. El estudio tiene como objetivo abordar una necesidad médica no satisfecha, ya que actualmente no hay opciones de tratamiento aprobadas para la babesiosis crónica, una condición que está emergiendo en nuevas regiones de EE. UU.

60 Degrees Pharmaceuticals (NASDAQ: SXTP)는 만성 바베시아증 치료를 위한 ARAKODA® (타페노퀸)의 2상 임상 연구에 대한 IRB 승인을 받았습니다. 이 오픈 라벨 연구(NCT06656351)는 외래 진료 환경에서 90일 동안 약물의 효능과 안전성을 평가하며, 최소 6개월 동안 상당한 기능적 장애를 겪은 만성 바베시아증 의심 환자를 대상으로 합니다.

환자 등록은 2025년 3분기에 시작될 예정입니다. 이 회사는 2035년 12월까지의 총 누적 대상 시장이 (미국 특허 보호 종료 시점) 400,000명 이상의 환자를 초과할 것으로 예상하고 있습니다. 이 연구는 현재 만성 바베시아증 치료 옵션이 없기 때문에 충족되지 않은 의료 필요를 해결하는 것을 목표로 하며, 이 질환은 미국의 새로운 지역에서 발생하고 있습니다.

60 Degrees Pharmaceuticals (NASDAQ: SXTP) a reçu l'approbation de l'IRB pour une étude clinique de Phase II afin d'évaluer ARAKODA® (tafénoquine) dans le traitement de la babesiose chronique. L'étude en ouvert (NCT06656351) évaluera l'efficacité et la sécurité du médicament sur une période de 90 jours dans des environnements ambulatoires, visant des patients avec une babesiose chronique présumée ayant connu une altération fonctionnelle significative pendant au moins six mois.

L'enrôlement des patients est prévu pour Q3 2025. L'entreprise estime que le marché cumulatif total adressable d'ici décembre 2035 (fin de la protection par brevet aux États-Unis) dépasse 400 000 patients. L'étude vise à répondre à un besoin médical non satisfait, car il n'existe actuellement aucune option de traitement approuvée pour la babesiose chronique, une condition qui émerge dans de nouvelles régions des États-Unis.

60 Degrees Pharmaceuticals (NASDAQ: SXTP) hat die IRB-Zulassung für eine klinische Phase-II-Studie zum Einsatz von ARAKODA® (Tafenoquin) bei der Behandlung von chronischer Babesiose erhalten. Die offene Studie (NCT06656351) wird die Wirksamkeit und Sicherheit des Medikaments über einen Zeitraum von 90 Tagen in ambulanten Einrichtungen untersuchen und richtet sich an Patienten mit vermuteter chronischer Babesiose, die mindestens sechs Monate lang erhebliche funktionale Einschränkungen erfahren haben.

Die Patientenrekrutierung soll im 3. Quartal 2025 beginnen. Das Unternehmen schätzt, dass der gesamte kumulierbare adressierbare Markt bis Dezember 2035 (Ende des Patentschutzes in den USA) über 400.000 Patienten hinausgeht. Die Studie zielt darauf ab, einem nicht erfüllten medizinischen Bedarf nachzukommen, da derzeit keine genehmigten Behandlungsmöglichkeiten für chronische Babesiose existieren, eine Erkrankung, die in neuen Regionen der USA auftritt.

Positive
  • IRB approval received for Phase II clinical trial
  • Addressable market exceeds 400,000 patients through 2035
  • No current approved treatment options for chronic babesiosis (first-mover advantage)
Negative
  • Study enrollment won't begin until Q3 2025
  • Patent protection ends in December 2035

Insights

The IRB approval for 60 Degrees Pharmaceuticals' Phase II study of tafenoquine in chronic babesiosis represents a significant milestone with compelling market potential. Babesiosis, a tick-borne illness caused by parasitic infection of red blood cells, currently lacks FDA-approved treatments for its chronic form, creating a substantial unmet medical need.

The market opportunity is particularly noteworthy when compared to the company's current $1.97 million market capitalization. With an estimated addressable market of 400,000 patients through 2035, even modest market penetration and conservative pricing could generate meaningful revenue relative to the company's size. The geographic expansion of babesiosis cases in the U.S. further strengthens the market opportunity.

However, investors should consider several critical factors:

  • As a Phase II trial, significant development hurdles remain before potential commercialization, including the need for Phase III studies
  • The Q3 2025 enrollment timeline suggests potential approval would likely be 2027 or later
  • Open-label study design may impact the strength of efficacy data
  • Success rates for Phase II infectious disease trials historically range from 30% to 40%
  • Patent protection through 2035 provides reasonable commercial runway if approved

The study's focus on patients with 6+ months of functional impairment provides a well-defined target population and could support premium pricing if efficacy is demonstrated. The repurposing of ARAKODA®, already approved for malaria prophylaxis, may provide some regulatory advantages and risk mitigation compared to entirely novel compounds.

  • 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


FAQ

What is the market size for SXTP's tafenoquine treatment for babesiosis?

60 Degrees Pharmaceuticals estimates the total cumulative addressable market for ARAKODA (tafenoquine) in babesiosis treatment exceeds 400,000 patients through December 2035.

When will SXTP begin enrollment for the Phase II babesiosis trial?

Patient enrollment for the Phase II clinical study is expected to begin in Q3 2025.

How long will SXTP's Phase II trial for chronic babesiosis last?

The Phase II clinical study will evaluate ARAKODA's efficacy and safety over a 90-day period.

What is the clinical trial identifier for SXTP's babesiosis study?

The clinical trial identifier is NCT06656351.

When does SXTP's patent protection for ARAKODA expire?

The U.S. patent protection for ARAKODA (tafenoquine) expires in December 2035.

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