Treatment options for COVID-19 are currently limited with few effective therapies. Tens of millions of people around the world are infected with SARS-CoV-2, and nearly 2 million have died from this unprecedented global pandemic that has wreaked havoc on economies as well as healthcare systems. InVixa is developing an inhaled statin therapy that will potentially treat patients with COVID-19.
Our immediate focus is on treating COVID-19 pneumonia and Acute Respiratory Distress Syndrome (ARDS) in hospitalized patients using an inhaled statin formulation. In addition, there is also the potential to expand our treatment to treat those in the outpatient setting with milder disease.
Statins are one of the most successful and widely prescribed drugs in the history of the pharmaceutical industry with forecasted sales of over $1 Trillion by 2020. Owing to extensive safety data available for statins, InVixa’s product has a rapid route to market with label expansion opportunities.
Given the extensive global economic and healthcare burden of the pandemic, we expect the market to be receptive to multiple therapies that can be used in combination to defeat COVID-19.
Statins are often referred to as a ‘wonder drug’ as they are one of the most widely used $bn medicines globally. They are generally accepted to be safe, are easy to use, and are effective at improving outcomes in cardiovascular diseases through their known anti-inflammatory and cardio-protective properties.
Clinicians around the world began examining what existing therapies might potentially treat the devastating illnesses caused by SARS-CoV-2. Emerging observational clinical studies involving tens of thousands of patients showed that oral statin use was associated with improved outcomes in patients with COVID-19. Statin treatment was associated with a lower risk of all-cause mortality. The benefits are thought to be associated with reduced SARS-CoV-2 infectivity and beneficial immunomodulatory effects of statins.
However, when taken orally, statins appear to be ineffective in treating certain lung diseases such as asthma and COPD, and this may in part be due to the liver-avid uptake of statins and subsequent small fraction of drug that reaches the lungs and, in particular, the airways.
In pre-clinical studies and some observational clinical studies, some of the statins appear to have beneficial effects in attenuating the inflammation and damage associated with viral infections including influenza. Based on this logic, our mechanistic insights, and pre-clinical data in-hand, we are pursuing nasal and inhaled statin therapies for SARS-CoV-2 and COVID-19.
The InVixa team has first-hand pre-clinical experience in the development and use of inhaled statins for the treatment of asthma, and therefore, are perfectly positioned to take this approach forward into treating COVID-19.
COVID-19 is primarily a pulmonary disease given the virus mostly affects the airways and lungs. Complications in more severe cases include pneumonia with hypoxemia, respiratory failure, and ARDS leading to increased mortality, with over 1.8 million recorded deaths from the pandemic by the end of 2020.
The Company’s technology is based on innovative statin formulations designed for inhaled delivery, rather than by ingesting a pill. This is designed for better drug delivery to the nasal and airway passages to achieve much greater therapeutic effect at lower local statin concentrations than would be administered orally. Inhaling a statin gives much faster delivery of the drug to the lungs and at a lower dose, in the same way an asthmatic uses an inhaler to treat asthma symptoms of wheezing and breathlessness.
Statins inhibit the mevalonate pathway, a ubiquitous and fundamental metabolic cascade that is involved in numerous pathological processes throughout the body. By blocking this pathway, statins can dampen the hyper-immune response in the lungs, which causes the most severe, and sometimes fatal, COVID-19 symptoms.
This is an entirely different approach than that of a vaccine which relies on a person’s immune system being trained to recognize the COVID-19 virus and then mount an immune response to destroy it. As people get older, their immune system becomes less potent, a phenomenon known as ‘immunosenescence’ which may explain why elderly people are less protected by influenza vaccines.
InVixa’s approach is suitable for all adult age groups and is intended to provide an additional line of defence for those most vulnerable with the highest risk of death. It does not require any activation of the person’s immune system. Instead, it targets fundamental biochemical pathways to reduce viral entry into the lungs and dampen the hyper-inflammatory immune response that is associated with COVID-19 pneumonia, ARDS, and respiratory failure. We do not expect our approach to be affected by mutations in the virus leading to different strains.