60 Degrees Pharmaceuticals Study Results Published by New Microbes and New Infections Demonstrate Tafenoquine Exhibits Broad Spectrum Antifungal Activity
- Data showed tafenoquine does not exhibit cross-susceptibility with fluconazole against Candida spp.
- Effective treatment of drug-resistant Candida infections is an unmet need in U.S. market
- Presumed mode of action differentiated from standard of care treatment
New Microbes and New Infections is a peer-reviewed, open-access journal. The research was funded by the
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. 60P was recently awarded a
“A substantial unmet need exists for clinical therapies that treat and prevent life-threatening fungal infections,” said Chief Executive Officer of 60
About Candida auris (C. auris) and Rhizopus
Candida auris (C. auris) is an emerging fungus that presents a serious global health threat, according to the
C. auris carries a high mortality rate, killing more than 1 in 3 people with infections. Infections often emerge in healthcare settings, where people are particularly vulnerable. Rates are rising; the
Rhizopus species, one of the most common types of mucormycetes that cause mucormycosis, is a rare, life-threatening fungal infection that primarily affects immunocompromised humans, with an estimated mortality rate of 23–100 percent. Humans contract mucormycosis through contact with the fungal spores in the environment. The pulmonary form of the infection can occur after a person inhales the spores. Pulmonary and GI mucormycosis due to Rhizopus in children can be fatal when not promptly diagnosed and treated. In immunocompromised patients, the disease is typically progressive and frequently fatal.
About the Tafenoquine Antifungal Study
Minimum inhibitory concentrations (MICs) of medically important fungal pathogens were determined using conventional cell culture assays. The daily maximum tolerated dose (MTD) of tafenoquine was determined in neutropenic mice and the effect of two dose levels of tafenoquine on survival and fungal burden were assessed in Rhizopus and Aspergillus lung infections models. Mean MICS against panels of yeasts and dimorphic/filamentous fungi were 4.5 and 8.3 ug/mL. The MTD of tafenoquine was 5 mg/kg/day. Against Aspergillus, tafenoquine at the MTD did not increase survival or decrease fungal burden. Against Rhizopus, tafenoquine at the MTD decreased lung fungal burden in a dose-related manner. Survival in the high-dose MTD tafenoquine group was 30 percent whereas it was 0 percent in the vehicle group and in most legacy studies.
This research has used the NIAID suite of preclinical services for in vitro and in vivo assessments (Contract No. HHSN272201700039I 75N93019F00131).
About ARAKODA® (tafenoquine)
Tafenoquine was discovered by
According to the
Neither ARAKODA nor tafenoquine has been approved by FDA for treatment or prevention of fungal infections.
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 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.
Drug Interactions
Avoid co-administration with drugs that are substrates of organic cation transporter-2 (OCT2) or multidrug and toxin extrusion (MATE) 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
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Cautionary Note Regarding Forward-Looking Statements
This press release may contain “forward-looking statements” within the meaning of the safe harbor provisions of the
Media Contact:
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Source: Sixty Degrees Pharmaceuticals