Artemisinin for Treatment of COVID-19
Artemisinin derived from Chinese herb Artemisia annua L. (Sweet wormwood) has been used medicinally to treat fevers for centuries in China. Like other potential COVID-19 therapeutic agents such as Hydrochloroquine and Remesidivir, the efficacy of Artemisinin remains to be tested in well controlled and sufficiently powered clinical trials.
We discovered that Artemisinin is highly potent at inhibiting the ability of the COVID-19 causing virus (“SARS-CoV-2”) to multiply while also having an excellent safety index. Artemisinin is a natural derivative from the Asian herb Artemisia annua and has been used to treat malaria. We plan to seek additional support to evaluate clinical proof of concept studies to show the potential of Artemisinin to treat SARS-CoV-2 virus infection and COVID-19 complications. The addition of Artemisinin provides us with a number of candidates to address the SARS-CoV-2 virus with a combination of therapies including its leading drug candidate OT-101 and its antisense platform targeting the COVID-19 viral sequence. However, given the known safety profile and the widespread use of Artemisinin the company anticipates that clinical development of Artemisinin can be abridged to effectively deal with the current COVID-19 pandemic.
The discovery of Artemisinin, identified through our collaboration with GMP, could be the solution for COVID-19 pandemic. This discovery is particularly important since we have the potential to advance the program rapidly because it is based on technology and product that are readily available. Like other potential COVID-19 therapeutic agents such as Hydrochloroquine and Remesidivir, the efficacy of Artemisinin remains to be tested in well controlled and sufficiently powered clinical trials, but Artemisinin has many advantages against COVID-19. The newly reported results indicated that Artemisinin had an EC50 = 0.45 ug/ml and Safety Index = 140. In addition, Artemisinin is able to inhibit TGF-ß activity and is able to neutralize SARS-CoV-2 (COVID-19). The Companys’ test results during an in vitro study at Utah State University showed Artemisinin having an EC50 of 0.45 ug/ml, and a Safety Index of 140. Artemisinin can target multiple viral threats including COVID-19 by suppressing both viral replication and clinical symptoms that arise from viral infection. Viral replication cannot occur without TGF-ß. Artemisinin also has been reported to have antiviral activities against hepatitis B and C viruses, human herpes viruses, HIV-1, influenza virus A, and bovine viral diarrhea virus in the low micromolar range. TGF-ß surge and cytokine storm cannot occur without TGF-ß. Clinical consequences related to the TGF-ß surge, including ARDS and cytokine storm, are suppressed by targeting TGF-ß with Artemisinin.
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The availability of Artemisinin as a pre-existing dietary supplement may allow it to be deployed immediately in developing countries where the healthcare system can easily be overwhelmed. Its safety is clearly superior to chloroquine and remesidivir. The company intends to work with partners who have distribution networks in developing countries to provide a clean supply to avert a humanitarian crisis.
The Company planned a global study, ARTI-19, in India to contribute at least 120 patients to the total aggregate of 3000 patients. ARTI-19 in India was conducted by Windlas Biotech Private Limited (“Windlas”), the Company’s business partner in India, as part of the Company’s global effort at deploying ArtiShieldTM across India, Africa, and Latin America. For more information on developments after December 31, 2020, see Entry into MOU and Agreement with Windlas below.
In January 2021 and subsequently in February 2021, the Company announced preliminary results for ARTIVeda, or PulmoHeal, which is the Company’s lead Ayurvedic drug against COVID-19 in India and being developed by the Company in partnership with Windlas. ARTI-19 India is being conducted by Windlas as part of the Company’s global effort to deploy ARTIVeda across India, Africa, and Latin America. These interim results are based on 120 randomized patients across 3 sites in India. The ARTI-19 India trial completed enrollment of 120 randomized and we expect final data available 6-8 weeks thereafter. Upon completion of the trial results, it is the Company’s objective to file for Emergency Use Authorization (“EUA”) with regulatory authorities around the world, including India, the United States, and the United Kingdom; discussions regarding EUA with several of these authorities have commenced.
No adverse events were reported that required discontinuation of treatment. When ARTIVeda™ / PulmoHeal™ was added to the standard of care (“SOC”), more patients recovered faster than SOC alone.31 of 39 (79.5%) of patients taking became asymptomatic after 5-day of therapy. In comparison, only 12 of 21 control patients (57.1%) treated with SOC alone became asymptomatic on day 5 (P=0.028, Fisher’s exact test)For the sicklier patients (WHO scale 4), the median time to becoming asymptomatic was only 5 days for the ARTIVeda™ / PulmoHeal™ + SOC group (N=18), as compared to 14 days for the SOC alone group (N=10) (P=0.004, Log-rank test).These data sets provide clinical support that targeting the TGF-ß pathway with ARTIVeda™ / PulmoHeal™ may contribute to a faster recovery of patients with mild to moderate COVID-19. The trend was more pronounced with higher initial disease status. Log rank statistics: WHO-scale 2,3,4: p= 0.0369 /RR = 1.476 (0.8957-2.433), WHO-scale 3,4: p= 0.026/ RR = 1.581 (0.9094-2.747), WHO-scale 4: p= 0.0043/ RR = 2.038 (0.9961-4.168). RR = rate ratio for recovery. The Company has published the results of the trial in certain renowned publications.
In addition to ARTIVeda™ / PulmoHeal™, the Company has also developed and launched a mobile application called ArtiHealth and a post marketing survey that have been included with ArtiVeda, which along with ArtiHealth is called PulmoHeal™. PulmoHeal™ is a full evaluation package of drug and assessment platforms for COVID-19, and other respiratory disease patients. Windlas has launched PulmoHeal™ on Amazon.in and a couple other websites. The platform has been powered by the Company’s AI supercomputing and AI platform in conjunction with IBM. Initially, the cough assessment will be powered by Salcit Pvt. Ltd.’s (“Salcit”) AI module. Per Salcit, their AI module has overall accuracy in predicting the pattern of the disease at 91.97%, sensitivity at 87.2%, and specificity at 93.69%.
