The Pandemic Issue

for publication. Data from an additional fifty patients will be added.

even less capable of handling novel approaches that fall outside of its standard guidance.

“We got lucky and hit the bulls’ eye from a mile away,” says Jay Lalezari, the chief science officer of Cytodyn, the company behind leronlimab. Dr. Jay, as he is widely known in San Francisco, built an adoring fan base running many of the early-phase drug studies for treating HIV. While touting leron- limab, Lalezari suspects it might best be used as part of a combination therapy. The small, under-capitalized firm is struggling for attention in the vast pool of therapies proposed to treat COVID-19. It faces the added challenge of gaining acceptance because it is based on a different approach and mechanism of action, which involves a signaling molecule important to immune cell migration, than what most researchers and the FDA anticipate as being relevant to counter SARS-CoV-2. Common Issues All of the therapeutics under development will face some common sets of issues. One is the pressure to have results yesterday, because people are dying. The rush to disseminate information “make me worry that certain things will become entrenched as truth, even in the scientific community, without the actual scien- tific documentation that ordinarily scientists would demand,” says Hamburg. Lack of standardization in assays and laboratory operations makes it difficult to compare results between labs studying SARS-CoV-2. In the long run, this will slow down the iterative process of research that builds upon what has gone before. And the shut down of supply chains, from chemicals to cell lines to animals to air shipment, has the potential to further hobble research. Almost all researchers consult with the FDA in putting together their clinical trials. But the agency is over- whelmed with the surge of activity in the field, and is

“It is becoming increasingly clear that the biggest problem for drug and vaccine makers is not which therapeutics or vaccine platform to pursue. It is that conventional clinical development paths are far too lengthy and cumbersome to address the current public health threat,” John Hodgson wrote in Nature Biotechnology . Another complicating factor with this virus is the broad range of organ and tissue types it can infect. That has implications for potential therapies, which often vary in their ability to enter different tissues. At a minimum, it complicates the drug development process. Remdesivir has become the de facto standard of care. Ideally, clinical trials are conducted using the existing standard of care rather than a placebo as the control group. But shortages of the drug make that difficult and further inhibit learning what is the best treatment regimen for regular clinical care. “Understandably, we all really want to respond to COVID-19 in a much, much more accelerated fash- ion,” says Hamburg. But ultimately that depends upon “the reality of understanding the nature of the disease. And that is going to take a bit more time than we might like or wish.”

Bob Roehr is a biomedical journalist based and Washington, D.C. and author of the prize-winning leapsmag article about the world’s first known person who overcame HIV without medical intervention.


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