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60 Degrees Pharma Announces IRB Approval of Clinical Study of Tafenoquine for Treatment of Babesiosis in Immunocompromised Patients with Persistent Babesia microti Despite Prior Treatment

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60 Degrees Pharmaceuticals announced IRB approval for an open-label study of the ARAKODA® regimen of tafenoquine to treat persistent babesiosis in immunocompromised patients. The study aims to replicate the 80% cure rate observed in an earlier Yale School of Public Health case series. Tafenoquine, approved for malaria prophylaxis in the U.S., has not been proven effective for babesiosis treatment or prevention. The increasing incidence of babesiosis, a tick-borne illness, particularly affects the elderly and immunosuppressed. This clinical program is now enrolling at Tufts Medical Center.

Positive
  • IRB approval for tafenoquine study targeting babesiosis.
  • 80% cure rate observed in an earlier Yale School case series.
  • Tafenoquine study enrolling at Tufts Medical Center shows proactive steps.
Negative
  • Tafenoquine not yet proven effective for babesiosis treatment.
  • Not FDA-approved for babesiosis treatment.

The announcement of an ethics approval for an open-label, expanded access study of the ARAKODA® regimen of tafenoquine in immunocompromised patients with persistent babesiosis is a noteworthy development for several reasons. Firstly, the prior study conducted by Yale School of Public Health observed an 80% cure rate in a small cohort, which, although promising, was based on just five patients. This new study aims to confirm those findings on a larger scale, potentially providing more robust data. Investors should understand that the approval for expanded access doesn’t equate to FDA approval but represents a significant step towards it.

The medical community generally views the expanded access pathway as a double-edged sword. On one hand, it provides critically ill patients with potentially life-saving treatments. On the other hand, it doesn’t offer the controlled conditions of a traditional clinical trial, potentially affecting data purity. From an investor's standpoint, this study adds value by helping to validate the earlier findings, possibly accelerating the drug’s path to market, hence potentially impacting the company’s financials positively in the long run.

Additionally, the rising incidence of babesiosis, particularly in the Northeast, emphasizes the growing market need for effective treatments. While the drug is currently approved for malaria prophylaxis, its potential re-purposing for babesiosis treatment could open a new revenue stream for the company, enhancing its market position.

However, the drug’s effectiveness for babesiosis has yet to be proven and investors should keep an eye on subsequent clinical data before making any financial decisions.

This announcement has several financial implications for 60 Degrees Pharmaceuticals. Firstly, the confirmation of an 80% cure rate in a larger patient population could significantly boost investor confidence in the company’s pipeline. The positive outcomes from this study could drive the company’s stock price higher, given the unmet need for effective babesiosis treatment and the potential revenue streams from repurposing tafenoquine.

It's also worth noting that the company might face substantial costs associated with expanded access programs and subsequent clinical trials. However, these expenses could be justified if tafenoquine eventually receives FDA approval for babesiosis treatment, providing a competitive edge in a niche but growing market due to the rising incidence of babesiosis.

Investors should also consider the broader implications of this news. If successful, the re-purposing of tafenoquine could pave the way for similar initiatives with other drugs in the company's portfolio, offering a strategic advantage and potentially leading to more expedited approval processes for various indications.

WASHINGTON, July 09, 2024 (GLOBE NEWSWIRE) -- 60 Degrees Pharmaceuticals, Inc. (NASDAQ: SXTP; SXTPW) (“60 Degrees Pharmaceuticals” or the “Company”), a pharmaceutical company focused on developing new medicines for infectious diseases, today announced ethics approval of an open label, expanded access study of the ARAKODA® regimen of tafenoquine in combination with standard of care regimens in immunosuppressed patients with persistent/relapsing babesiosis.

The goal of the study is to confirm the findings of an 80 percent babesiosis cure rate in humans observed in a similar population in an earlier case series of tafenoquine completed by Yale School of Public Health (YSPH) in April 2024 and published in the journal, Clinical Infectious Diseases. The YSPH case series showed a cure rate (with a 95 percent confidence interval) of 80 percent (30-100 percent) in a series of five immunosuppressed patients who were administered weekly tafenoquine following a loading dose in combination with standard of care medications.

Tafenoquine is approved for malaria prophylaxis in the United States under the product name ARAKODA. 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 (FDA) for such an indication.

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. 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. It may be life-threatening in elderly and immunosuppressed patients.

Tafenoquine is showing exciting promise in addressing babesiosis within various human patient populations,” said Chief Executive Officer of 60 Degrees Pharmaceuticals, Geoffrey Dow, PhD. “With babesiosis rates now rising in key regions of the United States and given the very serious nature of this tick-borne illness, especially in the elderly and immunocompromised people, we are moving quickly in an effort to confirm Yale’s observations while advancing the clinical program for hospitalized babesiosis patients which is now enrolling at Tufts Medical Center. Ultimately, we aim to re-purpose tafenoquine as a new babesiosis treatment.”

Sometimes called “compassionate use,” expanded access is a potential pathway for a patient with a serious or immediately life-threatening disease or condition to gain access to an investigational medical product (drug, biologic, or medical device) for treatment outside of clinical trials when no comparable or satisfactory alternative therapy option is available.

About the 60 Degrees Pharmaceuticals Program for Tafenoquine in Babesiosis
60 Degrees Pharmaceuticals is engaged in advancing multiple clinical trials to establish the safety and efficacy of tafenoquine. They are the: 1.) study of hospitalized (i.e., acute) babesiosis patients, now enrolling at Tufts Medical Center; 2.) expanded access for Tafenoquine in Babesiosis trial intended to confirm recent findings by Yale School of Public Health; and 3.) expanded access study being planned for chronic babesiosis, the design of which will be gated by an ongoing epidemiological study at North Carolina State College of Veterinary Medicine assessing whether Babesia spp parasites are present in samples from human patients who have chronic fatigue/neurologic symptoms.

The three studies address unmet medical need in three important populations of human babesiosis patients: (i) patients hospitalized with severe disease; (ii) patients with persistent disease who have risk factors for relapse; and (iii) individuals with a diagnosis of chronic babesiosis based on clinical manifestations and prior medical history. Based on eventual data from all three trials, 60 Degrees Pharmaceuticals plans to file a New Drug Application with the FDA in the second quarter of 2026 for a supplemental indication for tafenoquine in babesiosis.

The Company believes that the total accessible market through the end of patent protection in December 2035 in the U.S. for ARAKODA (tafenoquine) for babesiosis is 38,000 (hospitalized and immunosuppressed) acute patients and at least 375,000 patients with chronic babesiosis. The prevalence of patients with chronic disease may be higher and is the subject of ongoing market research and epidemiological studies being conducted by the Company. This is in addition to the potential 1.7 million travelers who could benefit from the use of ARAKODA for malaria prophylaxis over the same period.

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 FDA for such an indication.

About ARAKODA® (tafenoquine)
Tafenoquine was discovered by Walter Reed Army Institute of Research with funding from 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.

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. The statements expressed herein are those of 60 Degrees Pharmaceuticals, Inc. and do not necessarily represent those of the U.S. Department of Defense.

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; 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 web site 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 did 60 Degrees Pharmaceuticals announce regarding tafenoquine?

60 Degrees Pharmaceuticals announced IRB approval for a study of tafenoquine for treating persistent babesiosis in immunocompromised patients.

What was the cure rate observed in the Yale School of Public Health case series for tafenoquine?

The Yale School of Public Health case series observed an 80% cure rate for tafenoquine in treating babesiosis.

Is tafenoquine FDA-approved for babesiosis treatment?

No, tafenoquine is not FDA-approved for the treatment or prevention of babesiosis.

Where is the current tafenoquine study enrolling patients?

The tafenoquine study is now enrolling patients at Tufts Medical Center.

What is babesiosis and who is most affected?

Babesiosis is a tick-borne illness affecting red blood cells, with symptoms including fever, chills, and fatigue. It severely affects the elderly and immunosuppressed patients.

60 Degrees Pharmaceuticals, Inc.

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