Interferon Beta Therapeutic May Soon Join the Fight Against COVID-19

Joining me now is Richard Marsden. He is the chief executive officer of Synairgen. Richard, Thanks for joining me.

Pleasure, John, thank you for inviting me.

I want to start off with this thought that you had many months ago when we started to see some light at the end of the tunnel. And you thought maybe you were coming late to the game in addressing COVID. And I watched an interview the other day that you had this great quote. I want to read it to you. You said, "COVID has proved to be particularly annoying. It just won't go away." How has that realization impact what you do?

Well, so well thank you for digging out the quotes. And I think recently, with this new variant, we see that we're still in the middle of this journey and this encounter with this virus. And I think we can't control what's happening around us, in terms of what the virus is doing, how many people end up in hospital. But it is proving to be a persistent problem. So on a day-to-day basis, we get on with what we can control. And we have to hope, for humanity's sake, that there are lots of teams around the world with the same mentality.

And we have to hope that some teams are very successful in developing therapeutics to go along with the vaccines that are needed to control this challenge.

Are therapeutics even more important now, given that we still have vaccine hesitancy around the world. We still have concerns about the effectiveness of the vaccine with these emerging variants. How has that influenced the speed in which you're working?

So we've been working as fast as we can as a team since January 2020 on this. And the virus is a moving target. And we welcome the advent of vaccines, which came along much faster and much better, I think, than most people expected at the tail end of 2020. And that's fantastic. But some people are cautious about using vaccines. We've got breakthrough infections, despite vaccines. And in years to come, we'll understand much more about what did happen here.

But the need for therapeutics is illustrated by the number of people who, despite everything, despite vaccines, despite lockdown measures, and despite the availability of antibody cocktails and drugs to come, people are still ending up in hospital. And I just looked at the numbers just now. And currently, that's around 5,000 patients per day ending up in hospital. And there is a need for therapeutics there. So anything we can do to keep people out of hospital, fantastic. But if it all goes wrong for an individual and they end up in hospital, there's a need for new therapeutics.

And where do you think this therapeutic might fit in best? What's going to be the ideal patient population?

Well, we're still learning. So we've got encouraging data from a phase-two trial that read out in 2020. We are really pleased with that data set. That led us into a much larger confirmatory trial, a phase-three trial that we started early this year in January. And we've completed recruitment for that trial. And we're expecting data early in 2002. And in this trial, the sprinter trial, we're testing the drug impatience where it's all gone wrong, they've been admitted to hospital. And it's kind of a landing place where these patients will get oxygen and maybe one or two other therapeutic options.

And the idea here is to get them out of hospital sooner and to get them-- once they've left hospital, we know with this virus, it's not a; certain journey back to what we would call normality or sort of no limitation of activities because of the infection they've just had. So if we can accelerate discharge and a fuller recovery, that would be fantastic. And then in this landing zone in hospital, I've talked about getting out of hospital. But sadly, a proportion will go from severely ill to critically ill and need ventilators.

And if we can reduce the proportion that deteriorate, even once they're in hospital, that would be fantastic. And we saw some encouraging signs of this in our phase-two trial. And the sprinter trial is designed to replicate that. So in terms of data, that's the first large chunk of data that's going to come along with SNG001 next year And if our data is really good and if COVID-19 remains a problem, then we will apply for an EUA as soon as we possibly can.

Do you expect COVID-19 to still be a problem next year?

I mean, we're probably all equally qualified to make a judgment on that. And anyone who says anything with any certainty around this virus is repeatedly proved wrong. So we just have to be there with data and fingers crossed that the data is good so that SNG001 might have a role to play.

What's been the role of regulators? We talked very briefly before coming on about the flexibility that has been shown by regulators around the world. You're in the UK. What has been that relationship? Some people will argue it should inherently be an area of tension between government regulators and sponsors. But here during the pandemic, we're seeing more collaboration between regulators and sponsors. What's been your experience so far?

I hope that history looks back kindly on industry, academia, governments, and regulators when it looks at how this pandemic has been handled in totality. And our own experience is that regulators have been very engaged in what we're doing and supportive of the clinical trials that were necessary, last year and this year, to work out whether our drug has got a role to play. So our experience has been that they've been very, very supportive and very easy to engage with.

Something we're starting to see with some therapeutics, they did very well in controlled trials, yet then in real world expansion, they're not doing so well. We recently saw it with Merck's antiviral. How do we put all of this into context for our viewers? Very encouraging data in a lot of clinical trials. But then when we put it into practice, not so much. Are we giving people false hope? Or are we not putting it in perspective for them? Is it we just have to move with certain rapidity, given that we're in the middle of a global pandemic? What are your thoughts on that?

Yeah, I mean, it's a tricky question again. I can't really speak for other therapeutics that have been tried and which might have not seen sort of the mass uptake in the pragmatic, real world. What I can say is with our drug, we're using technology that's routinely used in hospitals around the world currently. The drug, itself, is a drug that's been used for a couple of decades by injection. So we're taking something which has got a pedigree, a history behind it, and changing the route of administration.

We're trying to get this into the lungs of patients at a time of need where we understand that the virus is suppressing the production of this protein, interferon beta. And we're just trying to put it back in what we think is the right time and the right type of patient to counter what the virus is doing. And what I can say is that we've kind of stress tested the administration of this drug over time in our historic trials in asthma patients, in COPD patients, where they took the drug at home.

And in COVID times, we've stress tested other systems. So we did a home-based trial, just to see how the device was being used with the drug in the home environment. And here, patients received a cardboard box and the drug or placebo, because it was a placebo-controlled trial. And they were coached through on how to use it using a Zoom call. So we come stress testing it--

We would have never done something like that two years ago, pre-pandemic, this home based trial. So I have to ask you, has the COVID pandemic permanently changed the way we do trials?

I don't know. Again, I can say that what we've done is think about how to solve problems within a pandemic. And no doubt, some new precedents have been set for how trials are being conducted or could be conducted in the future. And I think we were lucky in that this wasn't our first dip into clinical trial. This is our fourth or fifth phase-two trial, so some of the risks were lower. And if you're trying a brand new drug that's not going near humans before, then you might be more cautious and want to map those patients encounter with the drug for seven days on a ward in a clinical trial unit.

So we could go in slightly differently because I think we were just the right company with the right idea with the right drug, the right approach, in the right environment, which was in the middle of a pandemic where we couldn't have done the trial any other way. The question had to be asked, how else were we going to do it?

Your best guess as to when the drug might be widely available?

So we get data early next year. And if the data is really good and if COVID persists as a problem, then we hope to file for an EUA. And there's precedent there from other people's programs, in terms of how long it takes from data through to submission through to availability. And that's measured in months in this pandemic, not years like it might normally be.

And I think the conventional wisdom right now is that COVID is going to be with us for quite some time, so we're going to need these therapeutics to help address this global pandemic. Richard, I want to thank you for taking the time today.

Thank you, John.