The Hill’s Steve Clemons talks with Mihael Polymeropoulos, president and CEO of Vanda Pharmaceuticals, to discuss the company’s phase three trial to address Acute Respiratory Distress Syndrome, which many COVID-19 patients are dying from and how the biopharmaceutical industry is moving the needle in the search for a treatment and vaccine to treat coronavirus.

Excerpts from the interview are below:

On the state of his company’s fight against acute respiratory distress syndrome

Vanda Pharmaceuticals CEO Mihael Polymeropoulos: As you said there's a lot going on — a lot of people working very hard— to figure out solutions in health to respond to this catastrophic pandemic crisis. As you mentioned, COVID-19 is a very scary infection, primarily because we know that some people end up with acute respiratory failure, and they die from the consequences of that infection. So, what we're doing is, we're trying to understand whether we can block this neuro-inflammatory process that ends up in the collapse of the lung. Tradipitant is a neurokinin 1 receptor antagonist, a molecule that interacts with this neuro-inflammatory pathway when it is initiated through Substance P. So the idea here is that administering an antagonist in the pathway, tradipitant, will block the inflammatory process and hopefully early enough so that it does not result in the mechanical ventilation support of the patients and the high mortality rates that we have been seeing.

Clemons: What is, what have you been seeing? I know that these are early trials and I don't know the rules on what you can disclose, but is it promising?

Polymeropoulos: I don't think we can say anything yet. This trial began just last week at Lenox Hill Hospital in New York. A few patients have already been randomized — and again this is a double blind study that is placebo controlled, meaning that on top of all the standard of care, half the patients are taking tradipitant and half are taking a placebo. And this is in order to ensure that we have a good experiment. The good news is that hopefully we can enroll the study quickly, and in the next two months and soon thereafter, we'll have the results. And again, we must try as a pharmaceutical industry a lot of solutions — some of them will work, others won’t — but we need to do good experiments and be able to either confirm or exclude a therapeutic.

Clemons: How hard has it been to move your researchers from your various research lines you had going to now focus on COVID-19 therapies and drugs?

Polymeropoulos: How come Vanda, a company that did not have a presence in antivirals, is actually in it now in a big and comprehensive way. That comes out of the conviction that as a pharmaceutical company not only do we need to develop drugs that can be helpful to people and hopefully be commercially successful, but we have a sense at Vanda of social responsibility. And that is, we are a pharmaceutical company after all. And while all of us are locked up in our homes, and we hope that somebody is going to treat us, somebody is going to find a cure. For employees of a pharmaceutical company, it is imperative that they jump in and try to do all they can. And that's exactly what we did at Vanda over the last month. We developed a comprehensive plan going after COVID-19 and we're looking at ways to interfere with the virus, the virus entry, the virus development and assembly inside the cell. And as we have been discussing in the last few minutes, with tradipitant and the ODYSSEY study to address the acute respiratory distress syndrome. The rest of the company is running as well. What you're seeing here is rising to the occasion. Of course, a couple of other studies in atopic dermatitis and gastroparesis are going to move a little slower. Hopefully, we'll catch up. But we thought as a pharmaceutical company, there's no option but actually to jump into COVID-19.

Clemons: Is the research ecosystem on COVID-19 chaotic or ordered in the right way?

Polymeropoulos: It's hard for me to know what is chaotic and what is not. But I will say that we've seen the FDA be very cooperative and trying to accommodate the projects and respond quickly. I’ll give an example. Beyond the projects we're doing now, we're pursuing additional projects as well, and we've seen a fantastic response in timing and willingness to collaborate. But I think there's an overarching need that we need to be very careful with. All of us hear about vaccines. We hear about the antivirals. We hear about the IL-6 inhibitors and the studies that are being done. We, as a scientific community of the industry, know very well that it's going to take a lot of different things to conquer the virus and conquer this disease. And we need to try them all. Past experience with difficult infections like HIV/AIDS have taught us that it takes a lot of strategies, that you need to try them all and they will evolve over time. So, Vanda’s approach of looking at many points in the evolution of the disease, we think, is the right thing to do. And we hope that the government can actually help us by encouraging this approach. The solution is not going to be just a wonderful vaccine 12 to 18 months from now. Hopefully that happens, and we never think about COVID-19 again. But the world is not perfect, and we're going to need antivirals. We're going to need them to be comprehensive and we're going to need the ways to help the people who are dying today. People are not dying just because the virus got into their cells. They die because of respiratory failure.

Clemons: I know you've been pushing to get more African Americans, Hispanics and Asians into clinical trials. Is that happening? Is that happening not only on your front, but other fronts? Is that a blind spot in this process?

Polymeropoulos: I think underneath that is that we know different people are going to respond differently. We still have no idea why some people end up in the hospital and end up on the respirator; some of them die and others are asymptomatic. What causes that? It is the same virus after all. We believe that there is a reason to look at how people respond. Not because of the disease burden and socioeconomic status, but because of the wonderful differences in our genetic makeup that makes us a diverse people. But this is exactly where the research project CALYPSO comes in. It is a project to uncover the genetic reasons of different responses to this infection — people are more likely or less likely to be infected or more likely to experience this severe disease or not. There is a significant role for the government here. We hear a lot about the elderly with underlying conditions. We need to be careful generalizing. It is not just the elderly with underlying conditions. It is that this virus affects people in ways that we don't understand, and people respond in ways that we don't understand. What makes that response different? It is very important that we do not over generalize that it is just the elderly and it is just underlying conditions. It's going to be a lot more and it's going to take a lot of work to figure it out.