60 Degrees Pharmaceuticals Announces Communication from the FDA of Intention to Respond to Tafenoquine-Babesiosis Trial Protocol Submission in April, 2024
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The FDA's communication regarding the babesiosis trial protocol submission by 60 Degrees Pharmaceuticals is a critical step in the drug development process. The active ingredient, Tafenoquine, which is already approved for malaria prophylaxis, is under consideration for a new indication. This is known as drug repurposing, a strategy that can reduce the cost and time associated with bringing a drug to market by leveraging existing safety and efficacy data. The potential expansion of Tafenoquine's indications could significantly impact 60 Degrees Pharmaceuticals' market position, as babesiosis is a niche but serious disease and current treatment options are limited.
For stakeholders, the delayed feedback from the FDA does not necessarily indicate a problem with the submission but does introduce uncertainty. Investors should note that the lack of a specified time frame for FDA response under the existing Investigational New Drug application means that the company's timeline for trial commencement is not guaranteed. The company's ability to maintain the projected start date despite this delay demonstrates operational resilience and effective risk management strategies. However, any further delays could impact the company's financial projections and stock performance.
From a financial perspective, the announcement of the FDA's intention to provide comments on the babesiosis trial protocol in April 2024 may lead to market speculation regarding the potential for regulatory hurdles or delays in the drug's development timeline. This could affect the stock volatility of 60 Degrees Pharmaceuticals in the short term. However, it's important to consider the long-term implications. If Tafenoquine is approved for babesiosis, it could open up a new revenue stream for the company and possibly lead to an expanded market share within the infectious disease sector.
Investors should also consider the opportunity cost associated with the waiting period for FDA feedback. During this time, the company's resources are tied up in the anticipation of the trial, which could delay other projects or investments. It is essential for investors to monitor the company's cash flow and burn rate during this period to gauge the financial health and sustainability of its operations.
The infectious disease pharmaceutical market is highly competitive and the successful expansion of a drug's indications can be a significant competitive advantage. Market research indicates that the incidence of babesiosis is on the rise, particularly in the northeastern United States. This suggests a growing market for effective treatments. As such, the outcome of the FDA's review of the babesiosis trial protocol is of keen interest to market participants.
Understanding the target demographic for babesiosis treatment and the potential market size is crucial for projecting the drug's commercial viability. Moreover, the company's decision to proceed under an existing Investigational New Drug application rather than submitting a new one could be a strategic move to expedite the process, reflecting an intimate understanding of regulatory pathways. The ability to navigate such complexities is a positive indicator of management's competence and the company's potential to succeed in bringing Tafenoquine to a new patient population.
WASHINGTON, March 14, 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 that the U.S. Food and Drug Administration (FDA) has communicated its intention to send any comments regarding the Company’s babesiosis trial within the month of April, 2024, rather than March, 2024 as anticipated by the Company. The protocol submission mechanism as directed by the FDA, i.e., under the Company’s existing (rather than a new) Investigational New Drug application, technically does not require a response from the FDA within a specified time frame.
The Company is continuing preparations for a June 1, 2024 start date as previously communicated.
Tafenoquine is the active ingredient in an anti-malarial approved by the FDA in 2018 and is indicated for the prophylaxis of malaria in patients aged 18 years of age and older.
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, 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.
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:
- Patients with Glucose-6-phosphate dehydrogenase (G6PD) deficiency or unknown G6PD status.
- Lactating women who are breastfeeding 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.
- Patients with 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
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 at 1- 888-834-0225 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. ARAKODA® full prescribing information is 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 achieved FDA approval of its lead product, ARAKODA® (tafenoquine) for malaria prevention, in 2018. 60 Degrees Pharmaceuticals also collaborates with prominent research organizations in the U.S., Australia and Singapore. The 60 Degrees Pharmaceuticals mission has been supported through in-kind funding from the United States Department of Defense and private institutional investors including Knight Therapeutics Inc., a Canadian-based pan-American specialty pharmaceutical company. 60 Degrees Pharmaceuticals is headquartered in Washington D.C., with a majority-owned subsidiary in Australia. Learn more at www.60degreespharma.com.
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 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 our Annual Report on Form 10-K and our subsequent Quarterly Reports on Form 10-Q. 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 Contacts:
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 the FDA's comments on the babesiosis trial?
What is the start date for the babesiosis trial as communicated by the Company?
What is the active ingredient in the anti-malarial drug approved by the FDA in 2018?
What is the indication for Tafenoquine approved by the FDA?
