Artemisinin for COVID-19: Indian and US firms launch clinically tested supplement after ayurvedic regulatory approval
Artemisinin is a main compound found in the artemisia plant extract.
Registered as an ayurvedic drug, the supplement has been approved by the Food safety standards Authority of India (FSSAI) and AYUSH Ministry.
The supplement, which comes in the form of capsule, contains 500mg of purified artemisinin – trademarked ARTIVeda and protected by over 15 international patents.
ARTIVeda has also been used in clinical trials across three sites involving 60 patients in India.
The trial project, known as ARTI-19 India, is currently expanding and aims to recruit a total of 120 patients by end of January. Final data is expected to be available six to eight weeks thereafter.
Interim results based on the first 60 patients have shown no report of adverse events and that the patients who received the supplement had recovered faster than those who received standard of care alone.
“In Ayurveda, artemesia is known as Damanaka or Davana, which is an herbal medicine in use since hundreds of years for fever, inflammation and other respiratory illnesses,” Dr Vuong Trieu, chairman and CEO of Mateon told NutraIngredients-Asia.
The supplement will be sold under the product name PulmoHeal via online channels Amazon, Flipkart, and 1mg.com within this month.
The target consumers include COVID-19 patients and individuals who have been exposed to COVID-19 patients and are starting to experience symptoms, Saran Saund, chief business officer and GM of the AI division at Mateon, told us.
“The interesting aspect of this drug is that it is anti-viral, it treats symptoms, but it also can be taken prophylactically.
“If you suspect that you have been exposed [to a COVID-19 patient], you can then dose yourself with the supplement,” he said.
India is also the first market where the supplement is commercially available.
The product will be made available through the traditional pharmacy retail stores subsequently.
Trial design
According to the interim results, the benefits of ARTIVeda were more pronounced in patients with more severe symptoms, as compared to those who experienced mild symptoms.
During the randomised, parallel group trial, the patients received ARTIVeda in 500mg powder capsule with standard of care, or standard of care alone.
Standard of care is defined as treatment with the medicines remdesivir, ivermectin, dexamethasone, heparin, as well as paracetamol, B complex, vitamin C, and zinc.
The administration of ARTIVeda is given in three cycles.
Each cycle will see the patients take in a capsule containing 500mg of ARTIVeda per day for five days.
They will then stop the intake for the next five days.
If the symptoms persist, they will repeat the cycle for the second time.
Interim results also showed that the median time to asymptomatic World Health Organisation (WHO) scale of 1 was five days for ARTIVeda plus standard of care, as compared to 14 days for standard of care alone.
“This means that half the intervention group would have recovered within five days, which is about three times faster than the group which only received standard of care,” Dr Vuong Trieu explained.
He added that most of the patients only needed to undergo one round of the treatment cycle, with the exception of three of them who went on to the second cycle.
The ARTI-19 trial will also be extended to Africa and Latin America, as well as recruiting patients with co-morbidities.
Once the trial is completed, the company will file for Emergency Use Authorization (EUA) with regulatory authorities around the world, including India, the US, and UK.
According to the company, discussions regarding EUA with several of these authorities have commenced.
Dr Vuong Trieu said the company was also in talks with partners from South Korea and Philippines in conducting the trial.
TGF-beta activity
Mateon has hypothesised that ARTIVeda was able to suppress viral replication and clinical symptoms due to the viral infection by acting as a TGF-beta inhibitor.
The company has been a developer of TGF-beta therapeutics for oncology for over a decade.
“This is built on our knowledge of TGF-beta and virus replication. We have been working on TGF-beta for a long time, over 10 years.
“It is when COVID-19 happened that we understand that TGF-beta is important in COVID-19 and we jumped on the fact that there is this ayurvedic medicine that has TGF-beta activity and we took that into cell-based assay and into clinical trial,” Dr Vuong Trieu said.
Asked if the ayurvedic drug could be resistant against the mutated strains of COVID-19, he explained: “we originally developed this drug to be agnostic of mutation, because we are targeting the host protein [TGF-beta].
“The host protein doesn’t mutate, and so whether the virus mutate or not, it made no difference, so we expected our drug to be equally effective against all the variants.”
