The Data Safety Oversight Board recommends the completion of the phase II study to assess the efficacy and safety of ARAKODA® (tafenoquine) for the treatment of mild to moderate Covid-19 disease
WASHINGTON, 12 October 2021 / PRNewswire / – 60 Degrees Pharmaceuticals, LLC (60P), a pharmaceutical company focused on the development of novel drugs for infectious diseases, today announced that a Data Safety Oversight Committee has recommended the continuation of its clinical trial which evaluates the safety and efficacy of ARAKODA® (tafenoquine) for the treatment of mild to moderate COVID-19 disease in adults aged 18 years and older [see details of the study at: Tafenoquine in Patients With Mild to Moderate COVID-19 – Full Text View – ClinicalTrials.gov].
The trial aims to randomly assign up to 275 ambulatory patients with confirmed COVID-19 disease into two treatment groups, half of whom will receive tafenoquine and the other half a placebo. Clinical recovery within 14 days of treatment is being assessed as the primary endpoint. An efficacy-based protocol futility analysis was conducted by the study‘s Data Safety Oversight Committee, after approximately one-third of subjects completed their day 14 visit. The DSMB recommended the completion of the study after performing the analysis.
“Based on this recommendation, we hope that ARAKODA® (tafenoquine) may have the potential to be effective in the treatment of COVID-19 and look forward to the full results of the trial, ”said Geoffrey Dow, CEO of 60P.
60P is looking for partners to complete the research, development and, potentially, the future commercialization of ARAKODA® (tafenoquine) for additional indications.
ARAKODA® (tafenoquine) has not been proven safe to treat or prevent COVID-19. Screening for G6PD (glucose-6-phosphate dehydrogenase deficiency) is mandatory before prescribing ARAKODA®.
The clinical study was funded by 60 Degrees Pharmaceuticals LLC and the Joint Project Leader of the DOD Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) for Chemical, Biological, Radiological and nuclear (JPM CBRN Medical), with the goal of establishing a safe and effective treatment for COVID-19 by reallocating the drug approved by the FDA.
Tafenoquine was originally discovered by the Walter Reed Army Institute of Research. The US Army Medical Device Development Business (USAMMDA) and 60P first entered into a research and development cooperation agreement in 2014, to develop tafenoquine as a weekly prophylactic drug for the prevention of malaria. After becoming the first antimalarial product in over 18 years to gain FDA approval, 60P made its first major shipment of tafenoquine to the U.S. military in 2019. ARAKODA® is distributed through pharmaceutical wholesale networks in the United States and is available at retail pharmacies as a prescription malaria prevention drug only.
According to the CDC, the long terminal half-life of tafenoquine may offer potential benefits in less frequent dosing for prophylaxis of malaria.[i] At approved doses in healthy individuals, tafenoquine does not prolong cardiac repolarization [QTC interval].[ii]
ARAKODA® is not for everyone, and patients and prescribers should review the Important safety information below.
ARAKODA® (tafenoquine) Important Safety Notice and Information
ARAKODA® is an antimalarial indicated for the prophylaxis of malaria in patients 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 nursing woman when the infant is deficient in G6PD or if the 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®.
Warnings and precautions
The most common side effects (incidence 1%) were headache, dizziness, back pain, diarrhea, nausea, vomiting, increased alanine aminotransferase (ALT), motion sickness , insomnia, depression, abnormal dreams and anxiety.
Drugs interactionsAvoid co-administration with drugs that are organic cation transporter-2 (OCT2) substrates or multiple drug and toxin extrusion transporters (MATE).
Use in specific populations
Breast-feeding: Women should not breast-feed an infant with G6PD deficiency or an 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 the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. In Australia, contact Biocelect at 1-300-848-628.
About 60 pharmaceutical degrees
60 Degrees Pharmaceuticals, founded in 2010, focuses on the development of new drugs for the treatment and prevention of tropical diseases, including malaria and dengue. 60P’s mission is supported by in-kind funding from the US Department of Defense. The company also collaborates with leading research organizations in the United States and Australia. 60P is headquartered at Washington DC, with a subsidiary at Australia. Further information is available on the company’s website, www.60degreespharma.com.
Statements contained in this document may include forward-looking statements, statements of future expectations and other forward-looking statements that are based on the current beliefs and assumptions of management and involve known and unknown risks and uncertainties. Actual results, performance or events may differ materially from those expressed or implied in these forward-looking statements.
Geoffroy Dow, CEO of 60P
[ii] Green JA, Patel AK, Patel BR, Hussaini A, Harrell EJ, McDonald MJ, Carter N, Mohamed K, Duparc S, Miller AK. 2014. Tafenoquine as therapeutic concentrations does not prolong the corrected QT interval of Fridericia in healthy subjects. J Clin Pharmacol 54: 995-1005.
View original content to download multimedia:https://www.prnewswire.com/news-releases/data-safety-monitoring-board-recommends-completion-of-phase-ii-study-to-evaluate-the-efficacy-and-safety-of-arakoda- tafenoquine-for-treatment-of-mild-moderate-covid-19-301398568.html
SOURCE 60 Pharmaceutical Degrees, LLC