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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

April 08, 2025 08:31 ET | Source: Sixty Degrees Pharmaceuticals

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.

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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
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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

 

Original Press Release: https://www.globenewswire.com/news-release/2025/04/08/3057618/0/en/Sixty-Degrees-Pharmaceuticals-Announces-Patent-License-Agreement-to-Advance-Development-of-Tafenoquine-for-Babesiosis-Treatment-and-Prevention-with-Yale-School-of-Medicine-and-Yale.html

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When Selling Parties acquire, purchase or sell the securities of an Issuer, it could (i) cause significant volatility in the Issuer’s securities; (ii) if purchasing, cause temporary but unrealistic increases in volume and price of the Issuer’s securities; and (iii) if selling, cause the Issuer’s stock price and trading volume to decline dramatically resulting in Selling Parties making substantial profits while Recipients who purchase during the Campaign experience significant losses.

The Campaigns are designed to increase the trading price of the Issuers’ securities by encouraging the Recipients of the Information to purchase an Issuer’s securities despite that the securities may not be a good investment, and the trading price of the Issuer’s securities will dramatically decline when the Campaign ends. If you rely on the Information in the Campaigns when making an investment decision, you will likely lose your investment.

If the Issuer’s trading price increases during the Campaign, it is likely the result of buying activity caused by the Campaign and such increase does not reflect the Issuer’s prospects, financial condition or an increase in the value of the Issuer’s securities. If you rely on this buying activity when making an investment decision, you will likely lose your investment.

If Selling Parties hold or are compensated in improperly free-trading securities of the Issuers, either directly or indirectly, the Selling Parties and the Issuer could be the subject to an SEC Enforcement action, including allegations of an illegal distribution in violation of Section 5(a) and 5(c) of the Securities Act which could cause you to lose your investment.

The Publisher may hire service providers to disseminate the Information about the Issuers and the Publisher may not have control over such parties. The Publisher does do not verify the Information it receives from any party or information disseminated by other service providers. As such, you should not rely on the Information when making an investment decision.

The Information may contain statements asserting that an Issuer’s stock price has increased over a certain period of time which may reflect an arbitrary period of time, and such statements are not predictive or of any analytical quality. As such, Recipients should not rely on the Information as an analysis of the present or future potential of an Issuer or its securities. If you rely on the Information, you will likely lose your investment.

If any percentage gain of an Issuer’s securities from the previous day’s close is included in the Information, it is not and should not be construed as an indication that the future stock price or future operational results will reflect gains or otherwise prove to be advantageous to an investment in an Issuer. If you rely on the previous days close as an indication of performance, it could cause you to lose your investment.

Past results of an Issuer do not guarantee future performance. The Information should not be interpreted in any way, shape, form or manner whatsoever as an indication of an Issuer’s future stock price or future financial performance.

Recipients should consider the securities of the Issuers as high risk, unstable, unpredictable and illiquid which may make it difficult for Recipients to sell any securities of the Issuers that they purchase. During the Campaign the trading volume and price of the securities of each Issuer will likely increase significantly. When the Campaign ends, the volume and price of the Issuer will likely decrease dramatically. As a result, Recipients who purchase during the Campaign or as a result of the Campaign will probably lose most, if not all, of their investment.

SSA’s publication of the Information involves actual and material conflicts of interest including but not limited to the following: The Publisher receives monetary and/or securities compensation in exchange for disseminating the Information about the Issuers. The Publisher only publishes favorable information about the Issuers and does not publish any negative information about the Issuers.

The Paying Parties likely hold securities of an Issuer which they acquired from the Issuer, affiliate or non-affiliate shareholders or from its own open market purchases before, during or after the Campaign. The Paying Parties may have acquired these securities for services or at prices lower than that paid by Recipients.

The Paying Parties may sell these securities during the Campaign while the Publisher publishes the Information recommending that Recipients purchase. Selling by a Paying Party will likely cause Recipients who purchase securities of any of the Issuers to suffer losses.

COMPENSATION

We do not own any shares in SXTP We have been currently compensated One Hundred Thousand Dollars Cash ($100,000) via bank wire transfer directly from the issuer 60 Degrees Pharmaceuicals Inc for 1 Day of distribution of Marketing regarding SXTP with a start date of 4/08/2025.