WHO, FDA registered Antimalarial, Pyramax approved for coronavirus clinical trials
The World Health Organisation prequalified and Ghana Food and Drugs Authority registered Antimalarial Pyramax (Artesunate-Pyronaridine), a fixed-dose combination medication for the treatment of malaria, has been approved for clinical trials for Covid-19 in South Korea.
Also, it is being tried in South Africa, Kenya and Burkina Faso to pick African efficacy data.
The study, which is being led by the Liverpool School of Hygiene and Tropical Medicine, has the primary purpose to compare and evaluate Pyramax efficacy and safety in treating patients infected with the coronavirus, especially mild to moderate covid-19 infection and viral clearance (negative nasal swab) on Day 7.
Despite various drug development efforts, only vaccines led by AstraZeneca, Pfizer-BioNTech, Moderna, and more recently Sputnik V have been approved for the management of COVID-19.
Efforts towards drug treatment of COVID-19 is still ongoing. That notwithstanding, several drug molecules including drugs already approved for other diseases are emerging as providing benefits for the treatment of COVID-19 patients.
Between October 2020 to date, Sars-CoV-2 has manifested in three different variants from the original virus for which some vaccines were produced.
These mutations include the B.1.1351(501Y.V2) from South Africa, 501Y.V3 in Brazil and B.1.1.7 (501Y.V1) from the United Kingdom.
Following the higher transmissible nature of N501Y mutation familiar to all these variants from South Africa, Brazil and the UK, the projected impact of vaccines needs revision since highly transmissible variants lead to exponential growth in the number of infections.
This calls for consideration of alternative drug development avenues aside from vaccines.
Some drug molecules such as Pyronaridine, synthesized in 1970 at the Institute of Chinese Parasitic Disease has been used in China for over 30 years for the treatment of malaria.
Pyronaridine was approved as an orphan drug for the management of Ebola in different parts of the world and is showing promise in the fight against COVID-19 due to its antiviral properties.
In vitro studies comparing pyronaridine, artesunate and hydroxychloroquine against SARS-COV-2 show that pyronaridine-artesunate is more potent than hydroxychloroquine in the human lung epithelial cell line.
Artesunate, on the other hand, has similar antiviral properties and offers anti-inflammatory effects which suggest its potential usefulness in the treatment of COVID-19. The Estimated Study Completion date is September 30, 2021.
In 2017, Pyramax an oral drug produced as a result of a collaboration between Medicines for Malaria Venture (MMV), University of Iowa and Shin Poong Pharm, a South Korean pharmaceutical firm specializing in neglected tropical diseases were included in both the pediatric and adult Essential Medicines Lists of WHO for the treatment of uncomplicated malaria.
To enhance accessibility in Low- and Middle-Income Countries, the Global Fund has also included Pyramax in its list of drugs.
Internationally, Pyramax is registered in twenty-six countries with high malaria burden and locally registered by the Ghana Food and Drugs Authority since March 2020 for the management of uncomplicated malaria.