Positive Phase II Study Data for ARAKODA® (tafenoquine) in Patients with Mild-Moderate COVID-19 Disease Published by New Microbes and New Infections; Larger Studies Planned to Confirm ARAKODA Accelerates Clinical Recovery in Mild-Moderate COVID-19

• Clinical trial data suggesting that ARAKODA® (tafenoquine) exhibits a positive therapeutic signal in mild-moderate COVID-19 disease have been published in New Microbes and New Infections, a peer-reviewed, open-access journal.
• The drug increased the proportion of clinically recovered patients by between 9 percent (intent to treat population) and 14 percent (per protocol population); the drug decreased the proportion of clinically unrecovered patients by between 27 percent (intent to treat population) and 47 percent (per protocol population), but was underpowered to show statistical significance for the primary endpoint due to early termination of the study at n=86 patients.
• Results also showed that time to clinical recovery from COVID-19 symptoms was accelerated by about 2 – 2.5 days in the tafenoquine arm.
• The double-blind, randomized, placebo-controlled Phase II study was designed to evaluate whether, within 168 hours of mild-moderate COVID-19 symptom onset, administration of 8 x 100 mg tablets of tafenoquine as a 200 mg dose once per day on Days 1, 2, 3 and 10, in accordance with U.S. Food and Drug Administration (FDA) prescribing information for malaria prophylaxis, could increase the proportion of COVID-19 patients clinically recovered on Day 14 from 70 percent to 85 percent (i.e., a 50 percent reduction in the proportion of unrecovered patients).
• Larger studies are planned to evaluate tafenoquine efficacy in treating COVID-19.

WASHINGTON, June 21, 2022 /PRNewswire/ -- 60 Degrees Pharmaceuticals INC (60P), a pharmaceutical company focused on developing new medicines for infectious diseases, announced today that preliminary results of its phase II study of ARAKODA® (tafenoquine) for treatment of mild-moderate COVID-19 disease have been published in the peer-reviewed journal, New Microbes and New Infections. Data from the study demonstrate a numerical reduction in the proportion of patients not recovered on Day 14, and that the incidence of drug-related adverse events was low (8.4 percent) and mild. The study also showed that time to clinical recovery from COVID-19 symptoms was accelerated by about 2 – 2.5 days in the tafenoquine arm. 

ARAKODA is an anti-malarial indicated for the prophylaxis of malaria in patients aged 18 years of age and older. It has not been approved by the U.S. Food and Drug Administration (FDA) for use in COVID-19 disease and the safety and effectiveness of tafenoquine in this population have not yet been demonstrated.

"Data from this study give us reason to be cautiously optimistic, in our view, about the potential of tafenoquine to help shorten the duration of illness in patients who have COVID-19," said Geoffrey Dow, Chief Executive Officer of 60P. "We are pleased to have secured funding that enables us to plan additional studies to confirm and more deeply examine our recent findings."

The study was randomized, prospective, double-blind, and placebo-controlled, designed to test the hypothesis that 8 x 100 mg tablets of ARAKODA, administered within 168 hours of symptom onset as a 200 mg dose once per day Days 1, 2, 3 & 10, and in accordance with FDA prescribing information for malaria prophylaxis, could increase the proportion of COVID-19 patients clinically recovered on Day 14 from 70 percent to 85 percent (i.e., a 50 percent reduction in the proportion of unrecovered patients).

Clinical recovery was defined as cough being mild or absent, respiratory rate < 24 breaths per minute, and absence of fever and shortness of breath. Secondary and exploratory endpoints included adverse events, incidence of hospitalization and medical follow-up visits, proportion clinically recovered at Day 28, time to clinical recovery, patient-reported COVID-19 disease symptoms at Day 14, viral load, cytokines and antibody levels.

Adult volunteers were randomized (∼1:1) to receive tafenoquine or placebo and the study's inclusion/exclusions allowed participation of previously vaccinated individuals. The original design envisaged completion of the study by n=250 subjects to achieve adequate power. After n=86 patients were randomized, a protocol-mandated interim analysis was conducted and a Drug Safety Monitoring Board after reviewing efficacy and adverse event data, recommended completion of the study without modification. For strategic reasons related to a rapidly changing pandemic and competitive environment, 60P elected to terminate the study early and unblind the data from n=86 patients. Early unblinding made the study underpowered to achieve its primary statistical endpoint.

The study found ARAKODA numerically decreased the proportion of patients not recovered by 27 percent in the intent to treat population, and by 47 percent in the per protocol population. Results also show that time to clinical recovery from COVID-19 symptoms was accelerated by about 2 – 2.5 days in the tafenoquine arm.

There were drug-related adverse events in 2.4 percent of placebo subjects and 8.7 percent of tafenoquine patients, all of which were mild. There were three hospitalizations for COVID-19 pneumonia, two in the placebo group and one in the tafenoquine group.

Tafenoquine was discovered by Walter Reed Army Institute of Research and the current study was funded by the Department of Defense's (DOD) Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND), in support of the Defense Health Agency (DHA), with the goal of fielding a safe, effective treatment against COVID-19 by repurposing this FDA-approved drug (Contract: W911QY2190011). Tafenoquine was approved for malaria prophylaxis in 2018 in the United States as ARAKODA (tafenoquine) 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. It has been shown that tafenoquine inhibits SARS-CoV-2 replication in monkey kidney and human epithelial cells, and pharmacokinetic simulations suggest lung levels at the FDA-approved dose for malaria prevention may exceed the EC90 of the drug. These data provided the rationale for conducting the study of ARAKODA in mild-moderate COVID-19 patients. 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 is an antimalarial indicated for the prophylaxis of malaria in patients aged 18 years of age and older.

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
• Known hypersensitivity reactions to tafenoquine, other 8-aminoquinolines, or any component of ARAKODA.

• 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 17 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.

Avoid co-administration with drugs that are substrates of organic cation transporter-2 (OCT2) or multidrug and toxin extrusion (MATE) transporters.

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.

60 Degrees Pharmaceuticals INC (60P), founded in 2010, focuses on developing new medicines for infectious diseases. 60P's mission has been supported through in-kind funding from the U.S. Department of Defense. The Company also collaborates with prominent research organizations in the U.S. and Australia. 60P is headquartered in Washington D.C., with a subsidiary in Australia. Further information is available on the company's website.

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding our expectations surrounding the potential of our product candidates, ARAKODA, and expectations regarding our pipeline, including trial design and development timelines. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: uncertainty around and costs associated with the development of ARAKODA as a potential treatment for COVID-19 and our other product candidates; dependence on management, directors and other key personnel; the impact of the COVID-19 pandemic on our business; our need for substantial additional funding; our dependence on the success of our most advanced product candidates; risks related to the regulatory approval process; risks associated with the clinical development process and reliance on interim or topline clinical trial results; risks related to healthcare laws and other legal compliance matters; risks related to potential commercialization; risks related to manufacturing and our dependence on third parties; risks relating to intellectual property; our ability to maintain effective internal control over financial reporting and the significant costs as a result of operating as a company. These important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change.

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