COVID 19 THERAPY FAQS
The History of our Approach
When we started we expected years would pass until antiviral or antibody treatments were effective and set out to blunt or defeat the COVID-19 damage. Our initial concept assumed the virus would continue to spread, and a therapy was needed to eliminate the lung damage, organ damage and death so that people would simply contract the disease, take a medication in pill form and quickly recover.
Basis for Discovery
The basis for discovery was Dr. Norbert Voelkel's decades of lab work on both Chronic Obstructive Pulmonary Disease (COPD) and Pulmonary Arterial Hypertension (PAH) where one common feature is inflammation. In his over four decades of work trialing every drug he could find a rational for using, he had a number of possibilities to study. Both PAH and COPD are our lead indications.
Need for Multiple Mechanisms of Action
COVID-19 creates many damaging actions that include inflammation, thrombi, vascular leak and long term damage to organs. The body reacts to Covid-19 and the damage is caused from multiple responses from the bodies disease fighting mechanisms. For this reason, blocking one inflammation marker, will not address this disease effectively. For example, just because Interleukin-6 (IL-6) was reported to be highly elevated in COVID-19, this does not imply that IL-6 is central to the whole inflammatory mechanism. In fact, trials of drugs that block IL-6 have not surprisingly failed to arrest the COVID-19 induced inflammation. Inflammatory response involves a multitude of cell-cell interactions. The inflammatory cascade cannot be stopped by the single target approach. For this reason, blocking inflammation requires blocking multiple signals from the body that destroy the body.
Need for a Therapy
Sources of Discovery and Solution
It was relatively easy to map the destructive signals from COVID-19 that needed to be blocked to stop the inflammation, thrombi, vascular leak and long term damage to organs. Norbert's knowledge of various drugs, not today used for inflammation management, that have the needed mechanisms of action was critical and was possible - due to his decades of testing compounds and drugs to treat COPD and Pulmonary Arterial Hypertension. Note that both of these diseases effect the lungs and heart that are also attacked by COVID-19.
The final selection of our two drug cocktail was based on the virus replication characteristic and we were lucky in our discoveries. One of our compounds chelates the copper in the cell, disrupting virus replication and the other drug has a proven track record of defeating a Corona Virus (Not COVID-19) in animals and was also discovered to reduce the viral load in HIV positive patients by over 50%. For the foregoing reasons, we expect our two drug combination medication will meaningfully slow down the virus and reduce significantly the damage caused by inflammation.
Currently there are many vaccines being approved and in trials. The vaccines target various parts of the virus and train the immune system to start combating the virus more effectively. As with the common flu, there is a high probability of mutation of the common variant of the COVID-19 virus, requiring vaccination to be constantly updated, and likely challenging vaccine manufacturing to create the capacity to constantly deliver a new product and vaccinate the world in response to the inevitable mutations. In addition, vaccination will not be effective in every diseased patient in the near term or in the long term. Organ damage in diseased patients infected with the virus will not be prevented by vaccines because vaccines do not target the intravascular inflammation. Our ADVIR solution does target this intravascular inflammation.
Therapies are being developed, but safety and effectiveness are unknown at this time. These primarily include antivirals that interfere with virus replication and treatments that are based on antibodies directed against the virus itself.
Monoclonal antibody combination, Convalescent plasma and hyperimmune globulin, COVID-19 HIG, SAB-185, REGN-COV2 and others) are in development. When compared to the vaccines, while these antibodies and antivirals, may offer quicker, short-term relief in combating the virus, they may still (1) have the problem of effectiveness against mutated viruses, and therefore may eventually become less effective or obsolete (2) they will not be effective in the later stages of the disease and (3) do not address inter-vascular inflammation. For this reason, ARDVIR's treatment approach meets an un-met and very important need.