INDIANAPOLIS (WISH) — Eli Lilly and Company released partial results from their BLAZE1 clinical trial and scientists say there is reason to be optimistic.
The study launched in the beginning of August and was designed to evaluate the safety and effectiveness of an antibody treatment drug, LY3819253, in COVID-19 infected patients with one or more mild to moderate symptoms including low-grade fever, cough and shortness of breath, but did not require hospitalization.
News 8 spoke with Dr. Dan Skovronsky, chief scientific officer at Lilly. Skovronsky discussed the results of the latest study which, he said, are the most promising they’ve had to date.
Gillis: We’ve been following the BLAZE1 study and there’s some new data out. Talk about the new research. What are the outcomes of the study and why are they important?
Skovronsky: I’m going to back up a little bit and say some things about this study. This BLAZE1 study is the first one studied with a neutralizing antibody. It’s a drug made out of an antibody from a patient who recovered from COVID-19. It was created in our lab and is manufactured in our factories with the goal of neutralizing the virus hopefully before it can do harm to the patient.
It’s also the first trial ever in an early COVID-19 population. So, these aren’t people who are in the hospital or are very sick. These are people who’ve just gotten diagnosed and we’re trying to see if we can prevent those severe outcomes that sometimes happen with COVID-19. And that’s exactly what we saw. It’s still early data. But with the first 450 patients studied, we saw a very marked decrease in the number of hospitalizations in patients. So, treating with this antibody could reduce the viral load in the patient and the amount of virus that was alive in the patient. It could lower symptoms. But most importantly, it can lead to a decrease in hospitalizations, which can have huge implications if this continues to be successful.
Gillis: And you touched upon this, but why do you think the outcomes were so positive in terms of what you developed?
Skovronsky: It’s never been shown before that we could have a drug that could bring down the viral load and that that would lead to these kinds of outcomes. We haven’t really in the past understood why some people COVID-19 do so poorly and end up hospitalized while for others it’s a very mild illness. I think this data is starting to shine a light on that. It’s the first real breakthrough of any kind in this population. And I think we’re starting to learn that some people fail to clear the virus. For whatever reason their immune system can’t help them get rid of the virus. But this drug gives a boost to their immune system so it gets cleared out and they can get better. That’s what’s really exciting here…it’s the first glimmer of hope here. There’s light in this population and I think it suggests a whole class of medicines.
Gillis: And how did you decide on the dosage?
Skovronsky: We studied this antibody in the lab…in cells. We studied it in animal models and based on that we set a dose that we thought would be maximally effective in humans and we went up from there.
Normally in clinical development you don’t do that. You go down and try to find the smallest dose possible that could have an effect. But we didn’t want to take a chance that we underdosed the drug. There’s so much we don’t know about COVID-19 and so much we don’t know about these neutralizing antibodies. We decided that, given how short time is, let’s start at the dose we think is going to work and let’s march up from there and test some very high doses. So, that’s how we designed the study and we look forward to disclosing the results in a peer reviewed journal soon.
Gillis: And you’re planning future research to include a more representative sample size. What are your next steps? Can you share?
Skovronsky: Yes. Well, this data was even better than we had hoped it would be. So, we’re really excited. This is a single antibody. We also have a trial going on with a combination of two antibodies. That’s really interesting. But there’s not much more room for improvement here. The hospitalization rate we saw in patients was less than 2%. I don’t know if we can go any lower than that with the combination. We’ll find out soon enough. And then we have to decide whether we’re replicating the data with a single antibody, which can obviously help a lot more people because of manufacturing than two antibodies where you need twice as many. So, we will see in the coming weeks. But now there is reason to be hugely optimistic that we and others will have success with this kind of approach.
Gillis: And anything you’d like to add. Tell our Hoosiers.
Skovronsky: We’re just so grateful for all the patients and physicians who contributed to this research including many here and in Indiana. It’s been a huge collaboration all over the country that we’ve been proud to be a part of.
News 8’s medical reporter, Dr. Mary Elizabeth Gillis, D.Ed., is a classically trained medical physiologist and biobehavioral research scientist. She has been a health, medical and science reporter for over 5 years. Her work has been featured in national media outlets. You can follow her on Instagram @reportergillis and Facebook @DrMaryGillis.