Sixty Degrees Pharmaceuticals Announces Patent License Agreement to Advance Development of Tafenoquine for Babesiosis Treatment and Prevention with Yale School of Medicine and Yale School of Public Health
60 Degrees Pharmaceuticals (NASDAQ: SXTP) has signed a Patent License Agreement with Yale School of Medicine and Yale School of Public Health to advance the development and commercialization of tafenoquine for babesiosis treatment and prevention.
The agreement follows collaborative research between the organizations studying tafenoquine's activity against babesiosis, a tick-borne disease that infects red blood cells. Currently, tafenoquine is not FDA-approved for babesiosis treatment and prevention.
If approved, tafenoquine could address a significant unmet medical need, particularly for patients who progress beyond initial mild symptoms. The drug could potentially become the first prophylaxis available for babesiosis. According to Dr. Peter James Krause from Yale, relapsing babesiosis in immunocompromised patients has an estimated mortality rate of 20 percent and is challenging to treat.
60 Degrees Pharmaceuticals (NASDAQ: SXTP) ha firmato un Accordo di Licenza Brevettuale con la Yale School of Medicine e la Yale School of Public Health per promuovere lo sviluppo e la commercializzazione di tafenoquina per il trattamento e la prevenzione della babesiosi.
L'accordo segue una ricerca collaborativa tra le organizzazioni che studiano l'attività della tafenoquina contro la babesiosi, una malattia trasmessa dalle zecche che infetta i globuli rossi. Attualmente, la tafenoquina non è approvata dalla FDA per il trattamento e la prevenzione della babesiosi.
Se approvata, la tafenoquina potrebbe soddisfare un'importante esigenza medica non soddisfatta, particolarmente per i pazienti che progrediscono oltre i sintomi iniziali lievi. Il farmaco potrebbe potenzialmente diventare la prima profilassi disponibile per la babesiosi. Secondo il Dr. Peter James Krause della Yale, la babesiosi recidivante nei pazienti immunocompromessi ha un tasso di mortalità stimato del 20% ed è difficile da trattare.
60 Degrees Pharmaceuticals (NASDAQ: SXTP) ha firmado un Acuerdo de Licencia de Patente con la Escuela de Medicina de Yale y la Escuela de Salud Pública de Yale para avanzar en el desarrollo y la comercialización de tafenoquina para el tratamiento y la prevención de la babesiosis.
El acuerdo sigue a una investigación colaborativa entre las organizaciones que estudian la actividad de la tafenoquina contra la babesiosis, una enfermedad transmitida por garrapatas que infecta los glóbulos rojos. Actualmente, la tafenoquina no está aprobada por la FDA para el tratamiento y la prevención de la babesiosis.
Si se aprueba, la tafenoquina podría abordar una necesidad médica significativa no satisfecha, particularmente para los pacientes que progresan más allá de los síntomas leves iniciales. El fármaco podría convertirse potencialmente en la primera profilaxis disponible para la babesiosis. Según el Dr. Peter James Krause de Yale, la babesiosis recurrente en pacientes inmunocomprometidos tiene una tasa de mortalidad estimada del 20% y es difícil de tratar.
60 Degrees Pharmaceuticals (NASDAQ: SXTP)는 예일 의대와 예일 공공 보건대학과 특허 라이선스 계약을 체결하여 타페노퀸의 바베시아증 치료 및 예방을 위한 개발 및 상용화를 추진합니다.
이번 계약은 타페노퀸의 바베시아증에 대한 활동을 연구하는 두 기관 간의 협력 연구에 따른 것입니다. 바베시아증은 적혈구를 감염시키는 진드기에 의해 전파되는 질병입니다. 현재 타페노퀸은 바베시아증 치료 및 예방을 위해 FDA 승인을 받지 못했습니다.
승인될 경우, 타페노퀸은 초기 경증 증상을 넘어서는 환자들에게 특히 중요한 의료적 필요를 충족시킬 수 있습니다. 이 약물은 바베시아증에 대한 첫 번째 예방약이 될 수 있습니다. 예일의 피터 제임스 크라우스 박사에 따르면, 면역이 저하된 환자에서 재발하는 바베시아증의 예상 사망률은 20%이며 치료가 어렵습니다.
60 Degrees Pharmaceuticals (NASDAQ: SXTP) a signé un Accord de Licence de Brevet avec la Yale School of Medicine et la Yale School of Public Health pour faire avancer le développement et la commercialisation de tafénoquine pour le traitement et la prévention de la babesiose.
L'accord fait suite à des recherches collaboratives entre les organisations étudiant l'activité de la tafénoquine contre la babesiose, une maladie transmise par les tiques qui infecte les globules rouges. Actuellement, la tafénoquine n'est pas approuvée par la FDA pour le traitement et la prévention de la babesiose.
Si elle est approuvée, la tafénoquine pourrait répondre à un besoin médical important non satisfait, en particulier pour les patients qui progressent au-delà des symptômes initiaux légers. Le médicament pourrait potentiellement devenir la première prophylaxie disponible pour la babesiose. Selon le Dr. Peter James Krause de Yale, la babesiose récurrente chez les patients immunodéprimés a un taux de mortalité estimé à 20 % et est difficile à traiter.
60 Degrees Pharmaceuticals (NASDAQ: SXTP) hat eine Patentlizenzvereinbarung mit der Yale School of Medicine und der Yale School of Public Health unterzeichnet, um die Entwicklung und Vermarktung von Tafenoquin zur Behandlung und Prävention von Babesiose voranzutreiben.
Die Vereinbarung folgt einer gemeinsamen Forschung zwischen den Organisationen, die die Aktivität von Tafenoquin gegen Babesiose untersuchen, eine von Zecken übertragene Krankheit, die die roten Blutkörperchen infiziert. Derzeit ist Tafenoquin nicht von der FDA für die Behandlung und Prävention von Babesiose zugelassen.
Falls genehmigt, könnte Tafenoquin einen erheblichen ungedeckten medizinischen Bedarf decken, insbesondere für Patienten, die über die anfänglichen milden Symptome hinaus fortschreiten. Das Medikament könnte potenziell die erste Prophylaxe für Babesiose werden. Laut Dr. Peter James Krause von Yale hat die wiederkehrende Babesiose bei immungeschwächten Patienten eine geschätzte Sterblichkeitsrate von 20 Prozent und ist schwer zu behandeln.
- Potential first-to-market opportunity for babesiosis prophylaxis
- Partnership with prestigious Yale institutions strengthens development prospects
- Addresses high mortality rate (20%) market opportunity in immunocompromised patients
- Product not yet FDA approved
- Development and approval timeline uncertain
- Will require additional clinical studies and regulatory submissions
Insights
This patent license agreement marks a strategic expansion of 60 Degrees Pharmaceuticals' development pipeline, leveraging their tafenoquine asset into the underserved therapeutic area of babesiosis. The collaboration with Yale adds significant scientific credibility to this development program.
The agreement represents a classic case of indication expansion - potentially extracting additional value from an existing compound by targeting a new disease. Babesiosis represents a compelling opportunity due to several factors:
- The
20% mortality rate cited for relapsing babesiosis in immunocompromised patients clearly demonstrates the serious unmet medical need - The potential to develop both treatment and prophylactic applications creates dual market opportunities
- Being potentially first-to-market for babesiosis prophylaxis would establish a strong competitive position
From a development perspective, repurposing existing compounds typically offers accelerated pathways to market compared to novel molecule development, potentially requiring less investment while leveraging existing safety data.
While this news demonstrates positive pipeline progress, investors should note the announcement lacks details on development stage, timeline to potential approval, or commercial terms of the agreement. The relative rarity of babesiosis compared to other infectious diseases also raises questions about ultimate market size and revenue potential.
WASHINGTON, D.C., April 08, 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 the signing of a Patent License Agreement with Yale School of Medicine and Yale School of Public Health to jointly advance the development and commercialization of tafenoquine for the treatment and prevention of babesiosis.
Tafenoquine is not currently approved by the U.S. Food and Drug Administration (“FDA”) for the treatment and prevention of babesiosis.
The agreement follows initiation of collaboration between researchers from both organizations to study the activity of tafenoquine against babesiosis, a serious tick-borne disease caused by microscopic parasites that infect red blood cells.
“This agreement demonstrates the growing confidence 60 Degrees Pharmaceuticals, Yale School of Medicine, and Yale School of Public Health have in the potential that tafenoquine is now showing as a next-generation therapeutic for babesiosis,” said Chief Executive Officer of 60 Degrees Pharmaceuticals, Inc., Geoff Dow, PhD. “Today, a babesiosis patient who progresses past the initial stages of mild symptoms may have limited treatment options. If approved, tafenoquine has the potential to meet this growing unmet need. Tafenoquine also has the potential to become the first prophylaxis available for babesiosis.”
“Relapsing babesiosis occurs in highly immunocompromised patients, is very difficult to treat, and has an estimated mortality rate of 20 percent. There is a critical need to develop new antimicrobials for use in these patients,” said Peter James Krause, MD, Senior Research Scientist in Epidemiology (Microbial Diseases), in Medicine (Infectious Diseases) and in Pediatrics (Infectious Disease) and Lecturer in Epidemiology (Microbial Diseases) at Yale University.
About Babesiosis and the Study of Tafenoquine for Patients Hospitalized with Babesiosis
Babesiosis is a steadily emerging, infectious disease caused by a microscopic parasite, Babesia. It is transmitted through the bite of the black-legged (deer) tick, the vector that also spreads Lyme disease. Babesiosis, an orphan disease, may be life-threatening in elderly and immunosuppressed patients. Up to 10 percent of Lyme disease patients may be coinfected with Babesia. Therefore, up to 47,600 of the estimated 476,000 patients with new Lyme infections each year may be coinfected with Babesia. Cases reported in the medical literature suggest tafenoquine is a promising therapeutic for patients with relapsing babesiosis. The efficacy and safety of 8-aminoquinolines, a class of drugs that includes tafenoquine and primaquine, are well documented.
60 Degrees Pharmaceuticals is the sponsor of a clinical trial (NCT06207370) evaluating the efficacy and safety of tafenoquine in treating severe babesiosis in humans. The trial is now enrolling and is being conducted at multiple sites in the U.S., including at Tufts Medical Center, Rhode Island Hospital, Yale University and Brigham and Women’s Hospital. The study is a randomized, double-blind, placebo-controlled trial that compares the safety and efficacy of tafenoquine versus placebo in patients hospitalized for babesiosis and treated with standard-of-care. The two main study endpoints will be the time to sustained clinical resolution of symptoms and the time to molecular cure as determined by an FDA-approved nucleic acid test. At least 24, and as many as 33 patients, will be recruited before an interim analysis is conducted. The interim analysis will include both a test of significance, as well as size re-estimation to allow additional recruitment if required.
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 U.S. Food and Drug Administration for such an indication.
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 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:
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FAQ
What is the purpose of SXTP's patent license agreement with Yale?
What is the current FDA status of SXTP's tafenoquine for babesiosis?
What is the mortality rate for relapsing babesiosis according to Yale's research?
What potential market opportunity could tafenoquine represent for SXTP?
