On Oct. 5, 2020, Mateon Therapeutics announced that ArtiShieldTM had been approved for manufacture and marketing by the Ministry of AYUSH (Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homoeopathy), for the treatment of various symptoms like fever and inflammation. ArtiShieldTM is in co-development with Windlas Biotech, Mateon’s commercial partner for India. ArtiShieldTM is being evaluated against COVID-19 in ARTI-19- a phase IV study in India. ArtiShieldTM is designed to be a readily available and cost-effective agent to combat COVID-19, with Windlas providing the capability to manufacture the doses necessary to support this endeavor.

ARTI-19 in India is a “A Prospective, Randomized, Multi-center, Open label, Interventional Study to Evaluate the Safety and Efficacy of Artemisinin 500 mg capsule in Treatment of Adult Subjects with COVID-19”. This trial will compare the efficacy of oral doses with standard-of-care (SOC) versus SOC alone. Oral administration of Artemisia absinthium Powder 500mg capsule/day for 5 days with SOC per cycle with the option to repeat as needed until disease is resolved or subject is discharged, up to a total of consecutive 3 cycles (“5 days treatment, 5 days off”).

SOC is standard-of-care as per Clinical Management Protocol: COVID-19, Government of India Ministry of Health and Family Welfare Directorate General of Health Services (EMR Division). Safety is defined as: 1) Adverse events (AEs) during the study and 2) Serious adverse events (SAEs) during the study. Efficacy is defined as: 1) Relief in the sign and symptoms of COVID-19 as per WHO Clinical Progression Scale and 2) Relief in the sign and symptoms of COVID-19 per the Duration of Symptoms.

India’s COVID-19 death toll surged to pass 100,000 and on track to exceed US and 1,114 deaths were reported across the country in past 24 hours. India’s new cases detected per day are more than double the daily average of the United States and Brazil. India has emerged as the worst hit country globally in terms of new COVID-19 cases discovered every day. The country now has 6,549,373 total cases of coronavirus, including 937,625 active cases and 5,509,766 recoveries. A total of 101,782 people have lost their lives to COVID-19 till now.

ArtiShield^TM is the Ayurveda – Dvipaantara Damanaka- and is labeled as capsule containing Artemisia absinthium Powder 500mg. Its use in this trial is per Ayurvedic text: fever and inflammation. The application of Ayurvedic agent to treat the symptoms of COVID-19 such as fever, headache, and inflammation is appropriate. Artemisinin is an active component of ArtiShield^TM. Artemisinin is able to inhibit TGF-β activity and is able to neutralize SARS-CoV-2 (COVID-19) in vitro at an EC50 of 0.45 ug/ml (based on Mateon’s test result at Utah State University), and a Safety Index of 140, which is better than remdesivir and chloroquine. The unpurified herb extract has no anti-viral activity. ArtiShield^TM is designed to target multiple viral threats including COVID-19 by suppressing both viral replication and clinical symptoms that arise from viral infection. ArtiShield^TM is being evaluated against COVID-19 in ARTI-19- a phase IV study in India.