Therma Bright and InVixa are developing an inhaled statin therapy for the treatment of COVID-19 pneumonia and Acute Respiratory Distress Syndrome (ARDS) in hospitalized patients. The company’s technology is based on innovative statin formulations designed for inhaled delivery, which is intended to provide a greater therapeutic effect at lower local statin concentrations than would be administered orally. By blocking the mevalonate pathway, statins can dampen the hyper-immune response in the lungs, which causes the most severe COVID-19 symptoms.
Statins are widely used and generally accepted to be safe and effective in improving outcomes in cardiovascular diseases. Observational clinical studies have shown that oral statin use was associated with improved outcomes in patients with COVID-19. However, when taken orally, statins appear to be ineffective in treating certain lung diseases such as asthma and COPD, which is why InVixa is pursuing nasal and inhaled statin therapies for SARS-CoV-2 and COVID-19.
Our approach is suitable for all adult age groups and is intended to provide an additional line of defense for those most vulnerable with the highest risk of death. It does not require any activation of the person’s immune system, which may be less potent in older individuals. Our approach is entirely different from that of a vaccine, which relies on a person’s immune system being trained to recognize the COVID-19 virus and mount an immune response to destroy it.
Given the extensive global economic and healthcare burden of the pandemic, inhaled statin therapy may be a much-needed addition to the limited treatment options currently available for COVID-19. The extensive safety data available for statins also provides a rapid route to market with label expansion opportunities.
Our inhaled statin therapy works by delivering statins directly to the airways and lungs through inhalation, which can provide a greater therapeutic effect at lower local statin concentrations than would be administered orally. Statins inhibit the mevalonate pathway, a metabolic cascade involved in numerous pathological processes throughout the body, including the hyper-inflammatory immune response in the lungs that causes the most severe COVID-19 symptoms. By blocking this pathway, statins can dampen the immune response and reduce viral entry into the lungs, thereby potentially improving outcomes in COVID-19 pneumonia and ARDS. This approach is intended to provide an additional line of defense for those most vulnerable with the highest risk of death, without relying on a person’s immune system being trained to recognize and mount an immune response to the COVID-19 virus.
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