60 Degrees Pharmaceuticals to Submit MUMS (Minor Use/Minor Species) Designation Request to FDA for Tafenoquine for Acute Canine Babesiosis in 2025
60 Degrees Pharmaceuticals (NASDAQ: SXTP) announced plans to submit a Minor Use Minor Species (MUMS) designation request to the FDA for tafenoquine to treat acute canine babesiosis in 2025. The submission will be supported by three clinical efficacy studies that evaluated ARAKODA® (tafenoquine) for canine babesiosis, including one company-sponsored study at North Carolina State University.
The studies demonstrated that tafenoquine was well-tolerated and effective in treating both experimental and naturally acquired Babesia infections in dogs. This development is significant as there are currently no FDA-approved oral treatments for canine babesiosis, an emerging tick-borne illness that affects hundreds to thousands of dogs annually in the United States.
60 Degrees Pharmaceuticals (NASDAQ: SXTP) ha annunciato l'intenzione di presentare nel 2025 una richiesta di designazione Minor Use Minor Species (MUMS) alla FDA per l'uso di tafenoquina nel trattamento della babesiosi acuta canina. La domanda sarà supportata da tre studi clinici di efficacia che hanno valutato ARAKODA® (tafenoquina) per la babesiosi canina, incluso uno studio sponsorizzato dall'azienda presso la North Carolina State University.
Gli studi hanno dimostrato che la tafenoquina è stata ben tollerata ed efficace nel trattamento sia delle infezioni da Babesia sperimentali che naturali nei cani. Questo sviluppo è rilevante poiché attualmente non esistono trattamenti orali approvati dalla FDA per la babesiosi canina, una malattia emergente trasmessa dalle zecche che colpisce centinaia o migliaia di cani ogni anno negli Stati Uniti.
60 Degrees Pharmaceuticals (NASDAQ: SXTP) anunció planes para presentar en 2025 una solicitud de designación Minor Use Minor Species (MUMS) ante la FDA para tafenoquina destinada al tratamiento de la babesiosis canina aguda. La solicitud estará respaldada por tres estudios clínicos de eficacia que evaluaron ARAKODA® (tafenoquina) para la babesiosis canina, incluyendo un estudio patrocinado por la empresa en la Universidad Estatal de Carolina del Norte.
Los estudios demostraron que la tafenoquina fue bien tolerada y efectiva en el tratamiento de infecciones por Babesia tanto experimentales como naturales en perros. Este avance es significativo, ya que actualmente no existen tratamientos orales aprobados por la FDA para la babesiosis canina, una enfermedad emergente transmitida por garrapatas que afecta a cientos o miles de perros anualmente en los Estados Unidos.
60 Degrees Pharmaceuticals (NASDAQ: SXTP)는 2025년에 급성 개 바베시아증 치료를 위한 타페노퀸의 Minor Use Minor Species (MUMS) 지정 요청을 FDA에 제출할 계획이라고 발표했습니다. 이 제출은 ARAKODA®(타페노퀸)를 개 바베시아증에 대해 평가한 세 건의 임상 효능 연구에 의해 뒷받침되며, 그 중 하나는 노스캐롤라이나 주립대학교에서 회사가 후원한 연구입니다.
연구 결과 타페노퀸은 개에서 실험적으로 획득한 및 자연 발생 바베시아 감염 치료에 있어 내약성이 좋고 효과적임이 입증되었습니다. 이는 현재 미국에서 매년 수백에서 수천 마리의 개에게 영향을 미치는 신종 진드기 매개 질환인 개 바베시아증에 대해 FDA 승인 구강 치료제가 전무한 상황에서 중요한 발전입니다.
60 Degrees Pharmaceuticals (NASDAQ : SXTP) a annoncé son intention de soumettre en 2025 une demande de désignation Minor Use Minor Species (MUMS) à la FDA pour le tafénoquine afin de traiter la babésiose canine aiguë. Cette soumission sera appuyée par trois études cliniques d'efficacité ayant évalué ARAKODA® (tafénoquine) pour la babésiose canine, dont une étude sponsorisée par l'entreprise à l'Université d'État de Caroline du Nord.
Les études ont démontré que le tafénoquine était bien toléré et efficace dans le traitement des infections à Babesia expérimentales et naturellement acquises chez le chien. Ce développement est important car il n'existe actuellement aucun traitement oral approuvé par la FDA pour la babésiose canine, une maladie émergente transmise par les tiques qui affecte chaque année des centaines à des milliers de chiens aux États-Unis.
60 Degrees Pharmaceuticals (NASDAQ: SXTP) kündigte Pläne an, 2025 einen Antrag auf Minor Use Minor Species (MUMS)-Kennzeichnung bei der FDA für Tafenoquin zur Behandlung der akuten canine Babesiose einzureichen. Der Antrag wird durch drei klinische Wirksamkeitsstudien unterstützt, die ARAKODA® (Tafenoquin) bei caniner Babesiose untersuchten, darunter eine unternehmensfinanzierte Studie an der North Carolina State University.
Die Studien zeigten, dass Tafenoquin gut verträglich und wirksam bei der Behandlung sowohl experimenteller als auch natürlich erworbener Babesia-Infektionen bei Hunden ist. Diese Entwicklung ist bedeutsam, da derzeit keine von der FDA zugelassenen oralen Behandlungen für die canine Babesiose existieren, eine aufkommende durch Zecken übertragene Krankheit, die jährlich hunderte bis tausende Hunde in den USA betrifft.
- Positive efficacy results from three independent clinical studies
- Potential first FDA-approved oral treatment for canine babesiosis
- Leveraging existing safety and CMC data from ARAKODA malaria development
- Addressing an unmet medical need with current treatments having significant toxicity risks
- Gap analysis needed before MUMS designation submission
- Limited market size (hundreds to thousands of cases annually)
Insights
60P advances tafenoquine for canine babesiosis, targeting an unmet veterinary need with potential regulatory advantages through MUMS pathway.
60 Degrees Pharmaceuticals is making a strategic regulatory move by preparing to submit a Minor Use Minor Species (MUMS) designation request to the FDA for tafenoquine to treat canine babesiosis. The MUMS pathway is significant as it can provide regulatory incentives similar to orphan drug designation in human medicine, potentially accelerating approval and offering market exclusivity benefits.
The company is leveraging existing data from three clinical efficacy studies showing tafenoquine was well-tolerated and facilitated recovery from acute Babesia infections in dogs. Importantly, they're utilizing their existing safety and CMC data from ARAKODA's human malaria development program, which represents efficient use of their R&D investments across multiple indications.
This approach addresses a clear unmet veterinary need in the companion animal market - canine babesiosis affects several hundred to several thousand dogs annually in the US, with no FDA-approved oral treatments available. Current treatment alternatives apparently have toxicity issues or drug resistance concerns, positioning tafenoquine as a potentially valuable therapeutic option.
The veterinary application appears to complement 60P's human babesiosis research program, suggesting a comprehensive approach to this parasitic disease across species. This dual-species strategy could strengthen their overall clinical narrative and potentially create synergistic regulatory and commercial opportunities if successful in both human and veterinary markets.
- Data from three independent clinical studies demonstrate utility of tafenoquine to treat acute canine babesiosis
WASHINGTON, July 14, 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 that the Company will conduct a gap analysis of its existing data prior to submitting a Minor Use Minor Species (MUMS) designation request to the United States Food and Drug Administration (FDA) for tafenoquine for the treatment of acute canine babesiosis. The submission will be based on results of three clinical efficacy studies that evaluated ARAKODA® (tafenoquine) for canine babesiosis, and existing canine safety data and chemistry manufacturing and controls (CMC) data for tafenoquine generated through the clinical development of ARAKODA for malaria.
The clinical efficacy studies involved experimental Babesia infections and dogs diagnosed with naturally acquired Babesia infection in veterinary clinics. One of the studies was company-sponsored and conducted at North Carolina State University. Collectively, the studies showed that tafenoquine, administered as ARAKODA tablets, was well tolerated and appeared to facilitate recovery from acute infection.
Every year in the United States, several hundred to several thousand cases of canine babesiosis are seen. It is an emerging tick-borne illness carried by the same tick vector as Lyme Disease. No FDA-approved oral treatment for canine babesiosis exists, and currently available treatments carry significant toxicity risk or the propensity to generate drug resistance.
“Data from the canine babesiosis studies are impactful when viewed in the larger context of the ground-breaking human babesiosis research we are now sponsoring,” said Chief Executive Officer of 60 Degrees Pharmaceuticals, Geoff Dow. “The positive findings of the canine babesiosis study are in line with our earlier findings that tafenoquine could be effective against babesiosis in humans.”
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.
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.
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 60 Degrees Pharmaceuticals (SXTP) seeking from the FDA for tafenoquine?
How many clinical studies support SXTP's tafenoquine for canine babesiosis?
What are the current treatment options for canine babesiosis in the US?
How many cases of canine babesiosis occur annually in the United States?
What were the results of SXTP's tafenoquine studies for canine babesiosis?
