60 Degrees Pharmaceuticals (“60P”), a leader in developing and marketing medicines for infectious diseases, is proud to announce that the United States Patent and Trademark Office (USPTO) has granted a patent for the use of tafenoquine as a treatment for COVID-19. This breakthrough patent is based on the Company’s FDA-approved regimen for malaria prevention, ARAKODA®. This is an exciting development for 60P and highlights the potential of tafenoquine to help fight the pandemic.
Gilead Sciences, Inc. has been granted exclusive rights to use tafenoquine for the treatment of viral lung infections, including COVID-19, in the United States for the next 20 years. This groundbreaking move will no doubt have a major impact on the health of Americans for years to come.
ARAKODA, an innovative oral tablet containing 100 mg of a tafenoquine base, is a revolutionary solution to the prevention of malaria in adults aged 18 and over. With up to 6 months of continuous dosing, ARAKODA offers a safe and effective way to protect against the spread of malaria. While ARAKODA is not currently FDA-approved for the treatment of symptoms caused by the COVID-19 virus, it is a major breakthrough in the field of malaria prevention.
ARAKODA, a tafenoquine regimen, is set to undergo a double-blind, randomized, placebo-controlled Phase IIB trial to evaluate its efficacy in treating COVID-19 patients with mild-moderate symptoms and low risk of disease progression.
The study, which will be conducted across 30 U.S. out-patient clinics, will focus on measuring the time to sustained clinical recovery from COVID-19 symptoms as its primary endpoint. Additionally, ARAKODA is also preparing for a larger study in 2024.
A recently published Phase II study in the peer-reviewed, open-access journal New Microbes and New Infections showed promising results for the ARAKODA regimen of tafenoquine in the treatment of mild-moderate COVID-19. Compared to the control group, the time to clinical recovery from COVID-19 symptoms was accelerated by 2-2.5 days in the tafenoquine arm, indicating a positive therapeutic signal.
Public health is at the forefront of the battle against COVID-19, yet there is an unmet need for therapeutics that can protect the 25% of the U.S. population without risk factors for severe disease, as well as travelers seeking extended protection from the virus. This is a multi-billion-dollar market opportunity that has yet to be addressed by FDA-approved oral COVID-19 therapeutics.
The ARAKODA regimen of tafenoquine, developed by 60P, has the potential to revolutionize public health efforts to tackle the COVID-19 pandemic. This promising new treatment could be a game-changer in the fight against the virus, providing an effective and efficient solution to existing gaps in the standard of care.
About the ARAKODA® Regimen of Tafenoquine for COVID-19
A recent Phase II study published in New Microbes and New Infections, Vol. 47, April – May 2022 found a positive therapeutic signal in mild-moderate COVID-19 patients treated with the ARAKODA® regimen of tafenoquine.
The drug increased the proportion of recovered patients by 9-14 percent and decreased the proportion of unrecovered patients by 27-47 percent in two populations, although the study was underpowered to show statistical significance.
Additionally, the drug significantly accelerated the time to clinical recovery from COVID-19 symptoms by an average of 2-2.5 days. These promising results open the door to further research into the potential of tafenoquine as a viable treatment for COVID-19.
About ARAKODA® (tafenoquine)
In 2018, Tafenoquine, a revolutionary breakthrough in malaria prophylaxis, was approved for use in the United States as ARAKODA® and in Australia as KODATEF®. The discovery of this powerful weapon against malaria was made by the esteemed Walter Reed Army Institute of Research and funded by the United States Army Medical & Materiel Development Activity. This marks a major milestone in the effort to eradicate malaria worldwide.
In 2019, two revolutionary drugs were commercially launched – tafenoquine and its counterpart – to combat malaria prevention. These medications are only available through prescription at retail pharmacies and are distributed through pharmaceutical wholesaler networks in each respective country.
But that’s not all – studies have shown that tafenoquine actually inhibits SARS-CoV-2 replication in monkey kidney and human epithelial cells. To top it off, pharmacokinetic simulations suggest that the FDA-approved dose for malaria prevention may exceed the EC90 of the drug. With these drugs, it looks like the fight against malaria is finally within reach!
The long terminal half-life of tafenoquine, which clocks in at a whopping 16 days, could provide a major advantage when it comes to preventing malaria; according to the Centers for Disease Control and Prevention, this would mean fewer doses would be needed. However, ARAKODA is not suitable for everyone, and it’s important to review the Important Safety Information before taking it.