David Shaywitz, a physician-scientist and founder of Astounding HealthTech, recently wrote an article about the critical private partnership between the government and the biopharmaceutical industry in the current COVID-19 pandemic.
Shaywitz gave credit to his wife, who is also a physician-scientist working with Gilead. According to the article, she “has been working relentlessly to evaluate whether remdesivir, an anti-viral therapy the company originally developed for Ebola.” Shaywitz noted that while “anecdotal data, as widely reported, may be encouraging, robust clinical trials are required,” and his wife and her colleagues are “working literally day and night” to deliver a clear answer.
Gilead’s trials will evaluate two dosing durations of the intravenous drug and will involve randomized, open-label, multicenter studies with an estimated 1,000 patients (mostly in Asia and other countries with high numbers of diagnosed cases). The trials are expected to start in March. These Gilead trials are in addition to two clinical trials in the Hubei province of China led by the China-Japan Friendship Hospital and a recently launched trial in the United States.
According to Rear Admiral Richard Childs, an assistant surgeon general and lung specialist at the National Institutes of Health, fourteen Americans who contracted COVID-19 on the Diamond Princess cruise ship and of those fourteen, four received the drug from Gilead. Childs noted that he saw favorable changes in those who received the drug, but that it is “going to take us awhile to figure out what the impact of the drug has been.”
Even though Gilead and its team are performing trials on an ongoing basis, there are other companies working to develop and evaluate potential treatments, including potential vaccines.
Vaccines
Moderna has been working to develop a vaccine to combat COVID-19, reportedly using a proprietary artificial intelligence-based approach to select the part of the virus that will “most effectively goose our immune system.” The trial is being conducted at the Kaiser Permanente Washington Health Research Institute in Seattle and the first subject received the vaccine on Monday, March 16th. The trial will include forty-five young and healthy volunteers who will receive differing doses of the vaccines.
One unusual aspect of this vaccine is that it has not been tested first in laboratory animals. “I don’t think proving this in an animal model is on the critical path to getting this to a clinical trial,” Tal Zaks, chief medical officer at Moderna, told STAT. He pointed out that National Institute of Health (NIH) scientists are “working on nonclinical research in parallel.”
Inovio Pharmaceuticals expects to begin its trial at the University of Pennsylvania and a testing center in Kansas City, Missouri in April 2020.
Other Developments
Regeneron Pharmaceuticals and Sanofi have started a clinical trial of Kevzara (sarilumab) in United States COVID-19 patients who were hospitalized for severe illness. It will test 400 patients in about 16 sites in the U.S. Sarilumab is a human monoclonal antibody that inhibits interleukin-6 (IL-6), a proinflammatory cytokine. This is not a vaccine.
In times like this, public-private partnerships are critical. This is a historic opportunity for the industry and can offer ideas on how to handle this, and future, outbreaks. There are multiple ideas in the pipeline now, and the ideas continue to be put forth by biopharmaceutical companies and researchers daily.