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Welcome to BIOTECH NATION !!! With understandable interviews requiring no background in science, BTN attracts a wide global audience. From everyday people looking for hope in treatments in development, to bioentrepreneurs interested in the experience of their fellow travelers, to venture capitalists looking for possibilities in cutting-edge breakthroughs, to scientists simply interested in the work of others, BioTech Nation is the voice of human endeavor, driving science to new realities for everyone. These interviews are drawn directly from the public radio program, "Tech Nation", which also can be heard in numerous global radio and podcasting venues.
The world we know is changing. I'm Moira Gunn, and welcome to Biotech Nation. Doctor Daniel Bloomfield is the chief medical officer of Anthos Therapeutics. Daniel, welcome to Bio Tech Nation.
Dr. Daniel Bloomfield:Nice to see you. Nice to hear from you.
Dr. Moira Gunn:For any number of medical conditions and medical situations, there's a concern about blood clots. Just their general medical condition, people with cancer, people undergoing surgery, to name a few. I didn't really put it all together until you told me that 1 in 4 people, and I mean all people, 1 in 4 people die of a blood clot.
Dr. Daniel Bloomfield:So that's absolutely right, Moira. A huge number of patients die from blood clots and probably the most worrisome are heart attacks and strokes. And so given the number of people who die from strokes and heart attacks, we need to find medicines to prevent those from happening.
Dr. Moira Gunn:So what's the difference between, having a clot and just bleeding?
Dr. Daniel Bloomfield:Right. So your body needs to stop bleeding. If you get a cut, your body has a process of forming a blood clot to stop the bleeding, and that's normal. The blood clots that we're talking about are not normal. It's when the body creates clots abnormally, which cause certain types of disease or problems.
Dr. Daniel Bloomfield:Those blood clots are what we have to prevent. We wanna prevent the clots from happening, reduce the risk of stroke, but we don't want to affect bleeding. We want your body to still be able to form a clot to stop bleeding.
Dr. Moira Gunn:Now let's go into this. What happens when you have a blood clot?
Dr. Daniel Bloomfield:So so there are 2 types of blood vessels. There are arteries where the body, the heart pumps blood out to the body and brings oxygen to the tissues in the vital like muscles or or the brain. And blood clots in arteries means that those tissues don't get the oxygen they need, and the tissues can actually die. A heart attack is when part of the heart dies. A stroke is when part of the brain dies.
Dr. Daniel Bloomfield:And so that's the consequence of having a clot in an artery. Now on the other side, blood comes back to the heart through veins, and it goes back to the heart through the veins and eventually goes to the lung to get more oxygen. But in the veins, you can also have blood clots, and those blood clots can break off and cause a blood cut in the lung, which means you can't oxygenate your your blood properly. When you said 1 in 4 patients die of of blood clots, most of those are people who die of blood clots in the arteries. So this is a heart attack or a stroke.
Dr. Daniel Bloomfield:But you can also have clots in the veins. These veins is what brings the blood back to the heart. Goes back to the heart, goes through the lungs, gets more oxygen before it goes out again to the tissues. But blood clots in the veins can break off. And when they break off, they can travel up the heart and into the lungs and prevent the blood from being oxygenated properly.
Dr. Daniel Bloomfield:Now these blood clots are common in lots of people, but they're particularly common in patients with cancer, And that's a major issue that we're trying to to approach here.
Dr. Moira Gunn:Why is that prevalent in patients with cancer?
Dr. Daniel Bloomfield:When someone has cancer, there are things that happen besides just the cells getting bigger, causing a tumor. There are, in fact, different types of things that cancer cells can put out that actually increase your risk of having a clot. And in fact, the risk of having a clot if you have cancer is much, much greater than the risk of having a clot if you don't have cancer.
Dr. Moira Gunn:Now what are the standard treatments when you're in danger of having clots?
Dr. Daniel Bloomfield:So the standard treatments are blood thinners. You wanna thin the blood so that clots don't form. And these blood thinners, can be used to treat blood clots that are actively happening, and they could be used to prevent blood clots. If you think about the 1 in 4 patients who die, we wanna prevent those clots before they before they kill you. Right?
Dr. Daniel Bloomfield:That's that's the focus of a lot of research. How do we prevent those clots from happening? But if you show up in the emergency room with a clot, these blood thinners can also treat those clots. The treatment of blood clot started a long time ago with a drug called warfarin, And warfarin actually affects a number of different factors that are involved in clotting. The clotting process involves factors which together cause, plug to stick together and you form a plug that stops blood from from bleeding.
Dr. Daniel Bloomfield:And warfarin blocks a number of those factors and therefore, prevents clots from forming that are abnormal, like clots in the arteries and veins. But at the same time, it's affecting factors which are also needed for normal clotting to stop bleeding. Now since warfarin, we've now had a number of advances in the treatment of clots, and and these are new drugs now called factor 10 a inhibitors. Factor 10 a is another factor that's involved in the normal clotting process. Factor 10 a inhibitors, like Xarelto and Eliquis, are used both to treat clots and to prevent clots.
Dr. Daniel Bloomfield:And factor 10 a inhibitors are real advanced because they only affect one factor, not multiple factors, and they're much easier to use and prescribe.
Dr. Moira Gunn:However, I understand that MDs are afraid to use these.
Dr. Daniel Bloomfield:That's right, Moira. Because physicians, when faced with wanting to prevent someone from having a stroke or a heart attack or prevent someone from having a clot of any sort, are left with a decision, how much do I want to reduce the risk of clotting but not increase the risk of bleeding? And in some situations, physicians and patients are afraid of bleeding so much that they don't get the drugs that are used to prevent clots, which means they're at increased risk for getting clots.
Dr. Moira Gunn:It's a it's a it's a difficult, scale to to balance there. Now when we were talking earlier, I I often said to people, give me an example of a patient. And you said, well, there's my mother. It's like, yeah, tell the story of your mother. I mean, this is this is classic in a sense.
Dr. Daniel Bloomfield:Sure. So my mother was 82 a couple years ago, reasonably healthy woman, was playing cards, and all of a sudden, she couldn't hold her cards. Her cards dropped out of her hand, and then she began to slump over. And the people in the room knew this is probably a stroke. So they rushed her to the hospital.
Dr. Daniel Bloomfield:Sure enough, she was having a stroke. And they then treated her, and over the next couple days, actually, she improved and was left really with very little deficit from the stroke. But they were afraid of another stroke from happening, so they gave her blood thinners. And as you know, blood thinners are effective in preventing strokes, but they also have complications of bleeding. And 4 days after she got home, she had a massive bleed from her colon, lost about a third of the blood, and was hospitalized for 2 weeks till that stabilized.
Dr. Daniel Bloomfield:At that point, the doctors were stuck. I just saw this patient, my mother, bleed a lot, but I know she's at risk for having a stroke. So how do I balance that equation? And they decided, given how serious the bleed was, they were not gonna give her a blood thinner and wait until she stabilized. 2 weeks later, she had her second stroke.
Dr. Daniel Bloomfield:That's the challenge. Doctors are stuck trying to protect patients from having strokes, but they're also afraid of causing bleeding, and my mother's a perfect example of that. In fact, when this happened, I sent a note to my team saying, this is why we're here. This patient, my mother, is why we're trying to develop this drug.
Dr. Moira Gunn:I wouldn't be surprised if you just wrote hurry up.
Dr. Daniel Bloomfield:Get I did exactly that. I'll I'll send you the letter because it is does say hurry up.
Dr. Moira Gunn:Hurry up. Hurry up. So now what has Anthos done here?
Dr. Daniel Bloomfield:So I mentioned before that that there are factors which are involved both in normal clotting, but also involved in clotting that's abnormal. And factor 11 is one of those factors, which tends not to be involved in normal clotting, yet it's an important factor in causing clots. So if you can inhibit factor 11, you can try to prevent those clots, but the risk of bleeding will be very low. And we know that because patients who are born with factor 11 deficiency have essentially normal bleeding profiles. They they bleed like the rest of us, and yet they're protected from having strokes, and other clots.
Dr. Daniel Bloomfield:And so our drug and others are trying to recapitulate, are trying to create a situation where the human body acts like someone who's factor 11 deficient, and our drug then inhibits factor 11 to try to achieve that.
Dr. Moira Gunn:Now is this something that you would take a pill a day or how how does how would that work?
Dr. Daniel Bloomfield:Yeah. There's numbers of ways that we can treat patients. A pill a day or twice a day is a common way of treating patients, but there are also injections that you can use to treat patients. And our drug, will be a once a month injection. So instead of taking pills every day, you get a once a month injection.
Dr. Daniel Bloomfield:In some cases, people have to take injections every day, and this would be a real advance for them because they're taking one injection a month rather than injections every day.
Dr. Moira Gunn:Now you're you're pretty far along in this process. You've got at least 1 in phase 3, the last and largest to as you need to get drug approval, but you've also got a very large phase 2, number of other things working here for a different condition. Tell us what you're doing here.
Dr. Daniel Bloomfield:So we're developing a drug, and I'll give you the name. It's not an easy name to pronounce. It's called abalasumab, or we like to say it with an Italian version, abalasumab. I won't say that again, but that's the drug that we're we're developing. And we're developing this drug initially for 2 indications, 2 diseases that we wanna treat.
Dr. Daniel Bloomfield:The first is we'd like to treat patients who have an increased risk of having a stroke, where we know blood thinners are effective in preventing strokes. And we're doing a large phase 2 study in about 1200 patients to see whether or not our drug causes less bleeding than the currently available drugs because that's the important part of what we're doing. We wanna have the same benefit in preventing a stroke but cause less bleeding. So we're also developing our drug to treat and prevent blood clots in patients with cancer. As I mentioned, patients with cancer are much more likely to get blood clots than other people, and in fact, they're very disruptive to patients who are already sick and receiving chemotherapy.
Dr. Daniel Bloomfield:So we're getting ready to start our phase three trials, the studies that the FDA wants to see before our drug is approved. We're starting these phase three trials in patients who have cancer and present at the hospital with a blood clot. We have a plan that includes 26 100 patients in 2 studies that we believe will show there were at least as good as current therapies, but with less bleeding. That's our current plan, and we should, and these studies will be sufficient for the FDA to go ahead and approve the drug, and and approve it for the indication of treating and preventing clots and cancer. So in addition to the phase 3 studies we're doing in cancer, we're also preparing phase 3 studies for patients who are at risk for stroke.
Dr. Daniel Bloomfield:And those preparations are undergoing are being developed now and will depend in part on what we see in our phase 2 study, with patients at risk for stroke. So we have a lot going on.
Dr. Moira Gunn:I know that one of your studies, you looked at people with knee operations. This have obviously has to do with surgery, and I think that was a phase 2 study. I don't recall. I'd have to look at it again. Describe that study and what were the results?
Dr. Daniel Bloomfield:So patients that have knee replacements are prone to develop clots in the leg where they're having their knee replaced. And patients who have knee replacements are a perfect way to study blood thinners because you wanna know, can you prevent the clots in the leg from forming? This is study type of study has been done in many, many different, drugs for many, many years, and it's a sign that your drug does prevent blood clots. It was a phase 2 study, not a definitive study for the FDA, but to give us evidence that we could prevent blood clots. So our study, of about 400 patients compared 3 doses of our drug to a standard of care, and we showed an 80% reduction in the formation of blood clots in these patients.
Dr. Daniel Bloomfield:That gave us confidence to move forward with our program in cancer and our program with patients at risk for stroke.
Dr. Moira Gunn:I think this is really important for people to understand because so many people think that these clinical trials, these studies to approve drugs happen out of nowhere. Oh, we think we'll test it. Oh, look. It worked or it didn't. It's like, no, there's a lot that goes into it to make sure that the questions you ask are the right questions.
Dr. Moira Gunn:You have to learn a lot about the process.
Dr. Daniel Bloomfield:That's right. We did 4 phase one studies to learn enough about the drug, what the dose should be, how it works, before we were able to start our phase 2 studies. And our phase 2 study was done to show that we prevent clotting. That was the key finding, which lets us go into phase 3 studies where we actually try to prevent clots in patients, that need them.
Dr. Moira Gunn:Well, Dan, doctor Bloomfield, thank you so much for coming in. I hope you'll come back and keep us updated.
Dr. Daniel Bloomfield:Thanks, Moira. It's a pleasure to be here.
Dr. Moira Gunn:Listen to more biotech podcasts at biotechnation.com or subscribe on your favorite podcast provider. Bio Tech Nation is a regular feature of the weekly public radio program, Tech Nation. Listen to the full show via podcast or on your local public radio station. For Biotech Nation, I'm Moira Gunn.