Developing a COVID treatment with the goal of securing Emergency Use FDA Authorization and addressing a critical global healthcare need.
We have a near cure for late stage COVID-19. 93.6% survival rate in statistically significant study.
Mission Statement: CovInnovations is a company created to bring to market three COVID-19-related technologies: a successful treatment, a 2-minute RNA test and a susceptibility test. Company efforts have focused primarily on the treatment, since of the three technologies this has the greatest potential for social and financial benefit in the shortest amount of time.
The Problem: COVID-19 infection has two stages. The first stage is viral replication for which many drugs have been shown to provide benefit. Most people survive the first stage without serious incident. A small percentage go on to the second stage which is characterized by an overactive immune response referred to as a cytokine storm that often leads to death. There is no effective therapeutic available to treat COVID-19 in adults after the inflammatory phase of the disease takes hold other than dexamethasone, which provides mild benefit.
The Solution: We identified a drug which appears to terminate the cytokine storm by suppressing IL-6 activity. A retrospective study demonstrated a 68% reduction in mortality (p<0.05) and a 37% reduction in length of hospital stay (p<0.01). The treated group and the control group both received standard of care treatment as of 6/2020. Patients in the group provided the drug had a 93.6% survival rate as compared to the control group which had a survival rate of 78.5%. We added a second drug to improve performance, applied for a patent and hired FDA consultants to assist with the FDA Emergency Use Authorization process. There is nothing else like this available. We trademarked the name CovArrest.
Path to Revenue: We applied for patents and added a second drug which should act synergistically and thus improve survival rates. We have had our science reviewed favorably by professors and graduates of top US universities. We have written a randomized controlled trial protocol in coordination with a Harvard-trained immunology professor from South America. We have engaged FDA consultants who are guiding us through the FDA emergency use authorization process and providing advice on trial design. We are in the process of preparing our pre-IND letter. We are simultaneously pursuing approval in foreign countries recently hard-hit by COVID-19 with the assistance of one of our board members who formerly worked with US Commercial Services. We have engaged attorneys with specific expertise in pharmaceutical IP law, international commerce regulation, SEC oversight, and pharmaceutical contracting. One mentor is a CEO of a pharmaceutical company and who previously helped get cyclosporin through the FDA. We are in negotiations with a contract manufacturing pharmacy to produce the drug in the US for export.
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