New Study Reportedly Calls Into Question Merck's Ivermectin COVID Off Label Use And May Bolster 3CL Protease Inhibitors Such As Tollovid

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Even though Merck MRK released information about Ivermectin use in COVID-19, the New England Journal of Medicine published another study on the use of Ivermectin in COVID-19 last week. Ivermectin has been among the top alternative solutions for COVID since early reports in the pandemic suggested it could interfere with viral replication as well as improve outcomes for patients. However, if Ivermectin use decreases after continued publications reporting negligible effect, a vacuum of demand for all-natural alternatives, like Tollovid which is manufactured by Todos Medical TOMDF, could open up.

The New England study tested a “relatively high dose” of Ivermectin for 3 days to prevent patients from becoming hospitalized. The results were not statistically significant but showed a trend of reducing hospitalization rates from 16.5% to 14.7%. For the average person, it is arguably worth trying to find a solution that works better than reducing the risk of hospitalization by about 1.8%. The solution effect, if it existed, was too small to be statistically significant despite the study enrolling over 3,500 patients.

This is different from the 88-89% hospitalization or death reduction Pfizer’s PFE 3CL protease inhibitor, Paxlovid, demonstrated in its phase 2/3 trial for at-risk, symptomatic COVID-19 patients. Paxlovid also showed a 70% benefit for those at normal risk and confirmed efficacy against Omicron.

What might be the common denominator that explains this lack of efficacy of Ivermectin compared to other solutions that are approved or have shown clinical efficacy, such as Paxlovid and Tollovir, is that these drugs are all 3CL protease inhibitors but have varying levels of strength. In an interview, the CEO of Todos explained the different levels of binding strength.

Adequate Strength of 3CL Protease Inhibitors — Critical For Solution Effect? 

One way of looking at drug strength is to measure the blocking ability of its molecular target. So, for these 3CL protease inhibitors, one would compare the IC50 values, which give a snapshot of the drug’s strength by stating the concentration of drug required to block the 3CL protease’s activity by 50%. This is typically measured in “micromolar,” or how many drug molecules are required per volume of solution (i.e. blood). So, the smaller the number, generally the better the activity, to an extent.

This correlation between adequate IC50 and observable clinical benefit is seen in three different clinical trials using different 3CL protease inhibitors: Ivermectin, Paxlovid, and Tollovir. Tollovir is in development by Todos Medical TOMDF, and its phase 2 results for treating hospitalized COVID-19 patients were announced in January 2022.

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In the chart above, one can see that the 3CL protease inhibitors with a decent IC-50 (anything below 5µM, and for a pharmaceutical drug product, preferably under 1µM) were able to show robust clinical activity in reducing hospitalization or death rates, whereas ivermectin, possibly without enough protease-blocking activity, was reported to be unable to make a significant clinical difference.

Photo credit: Todos Medical

Is Long-Covid The Ultimate Indication?

The Brookings Institute made the case that long COVID is worsening the labor shortage and that an estimated 1.6 million people are disabled and out of the workforce due to the condition (in terms of equivalent full-time working hours). There are many theories as to the cause of long COVID but two commonly referenced schools of thought may be emerging. One school of thought led by Resa Pretorius suggests that “microclots” are behind the condition. Other researchers like Bruce Patterson believe in “viral persistence” which means the remnants of the virus irritate the immune system.

Possibly supporting the viral persistence theory are 2 breakthrough case studies from Pfizer and Todos that showed a resolution of symptoms shortly after taking the 3CL protease inhibitors. These case studies may end up leading to clinical trials in long COVID.

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