Freezing Out Chronic Pain…Sameer Sabir CEO, Brixton Biosciences
Ever had to ice your knee? Ever had pain in your knee or knees? Has the pain been persistent, as in all the time? Possibly diagnosed as osteoarthritis or just that darn sports injury. You know that an ice pack will help, but it can only go so far.
Dr. Moira Gunn:Here is a straightforward but still unusual approach which scientists have been working on for ten plus years. It's currently in clinical trials. Sameer Sabir is the CEO of Brixton Biosciences. Samir, welcome to Biotech Nation.
Sameer Sabir:Thank you for having me, Moira. It's a pleasure to be here.
Dr. Moira Gunn:Now I wanna start by reminding everyone how often we all use ice from our very own freezers to help us deal with one problem or another. You know, let's put some ice on that. What are we putting ice on, and why are we putting ice on it?
Sameer Sabir:Well, we've, known for millennia really that ice has therapeutic benefit, in many different ways, but the most common ways that we use it today are if you have, you know, exercise that's too vigorous, and want a little bit of a way to calm some of the inflammation in your joints or really in any situation where you have a minor sprain or bruise, ice can be effective as a way to help calm down inflammation. It's a wonderful tool.
Dr. Moira Gunn:In fact, this can also happen if you've just had surgery.
Sameer Sabir:Sure, yeah. Ice can also be used to help with swelling from surgery, from edema and other issues, incision sites. It's not just something that tamps down on inflammation. It also is soothing. I mean, it actually, helps, helps these sites feel better as well, which is, you know, half the half the battle.
Dr. Moira Gunn:So when we put this ice on the outside, it just it goes on the outside, but as it goes into the middle of, we'll just say, the knee Sure. It's gotta be less cold in there. Is that a problem?
Sameer Sabir:Yeah. I think, you know, typically, the way ice is used today, as, as an ice pack, you're You're treating things that are relatively superficial, and the cold doesn't necessarily penetrate, as deeply into the into the joint or wherever you may be putting it as one might want. So, it's definitely, limited, in its current, in its current, methodology of use, by the fact that it it is something that's applied topically, it's applied from the outside.
Dr. Moira Gunn:So it doesn't take a rocket scientist to say, golly, it'd be sure good if we could get that cold a little deeper. Yeah. This and this comes to the technology you're working on. Tell us, what is it that Brixton Bio is working on?
Sameer Sabir:Yeah. Well, Brixton Bio is working on a product that's called Neural Ice, and it's in its most basic form essentially an injectable an injectable version of ice. So it's not quite the same as the ice in is an ice pipe, but it is a formulation of ice, a proprietary formulation. And the idea is to be able to inject this ice directly around nerves because we know that when we apply ice to nerves, the nerve then undergoes somewhat of a transformation that reduces sensation for a long period of time, which results, from the patient's perspective in a reduction in sensation, a reduction in pain. So we're trying to put ice in it and not on it.
Dr. Moira Gunn:Now let me ask you this. Those of us who have had any kind of problem with our feet, our knees, even our hips, We're used to having the doctor say, well, we can give you an injection of one drug or another, and you could only have so many per year or you can only do this so many times. If I'm injecting this and it's ice, doesn't it just turn to sort of water?
Sameer Sabir:It essentially turns to water and some other components that are also biocompatible and is excreted out of the body. That's correct, Myra. It's a very benign formulation. We actually deliberately formulated the product with, ingredients that were all on what's known as the FDA's generally regarded as safe list, the excipients, the inert components. And so the product's actually considered to be a medical device because of the fact that, the composition is inert and the mechanism of action, is purely physical.
Sameer Sabir:The product works by virtue of the ice melting. That's what drives the changes to the nerve. And so, it's drug free, which we think is really exciting, because, as you mentioned, many of the treatments that are used today in, for example, treating osteoarthritis can be, quite damaging, if used, chronically. And so, we still need to demonstrate and and prove this out in clinical studies going forward. But our sincere hope is that this is something that not only will provide months of relief from a single injection, but it can also be used, multiple times, in patients.
Dr. Moira Gunn:Now why is it called neural ice as opposed to it's a lot of cold ice or ice ice or the ice?
Sameer Sabir:Well, that's a that's a great question. And, you know, what what we're trying to do, and this is underpinned by, almost a decade of research in an academic lab before we spun it out into Brixton, is to target the nerve that's causing the pain that the patient is dealing with. So if we take the knee, for example, which is the first indication that we're targeting, we're interested in helping patients who have osteoarthritis of the knee, and therefore have pain because of osteoarthritis. Now that pain gets transmitted through, a network of nerves that are known as the genicular nerves, and, we're going to target those genicular nerves, so nerves, neural neural ice. And the way that, neural ice works is that you essentially inject the neural ice around the nerve, you surround the nerve with the ice, and then as the ice melts, it extracts a significant amount of energy from the surrounding tissue.
Sameer Sabir:And that rapid extraction of energy from the surrounding tissue, which includes the nerve and specifically the myelin sheath, which is the sort of fatty layer of insulation around the nerve, that's disrupted. And when that's disrupted, that triggers this process whereby the nerve essentially is tamped down or desensitized for a period of time. And that's what causes the reduction in pain.
Dr. Moira Gunn:Now Neural Ice has received what's called a breakthrough device designation from the FDA. No surprise from my end given how many knees are listening to this interview right now saying, I hurt.
Sameer Sabir:Yeah. Yeah.
Dr. Moira Gunn:Get get this to me fast. But you're now doing clinical trial, and you are recruiting.
Sameer Sabir:That's right.
Dr. Moira Gunn:Who are you studying? What are you looking for? How long is Tell us the details here.
Sameer Sabir:Sure. So we've already done a series of, pilot studies, in patients, to, ensure that the product is safe and so on and so forth. And those studies were done in patients who, had chronic osteoarthritis of the knee, and pain as a result of that. And so our current, pivotal regulatory study, is that same patient population as patients who have chronic osteoarthritis of the knee. They need to have a minimum threshold of pain, to be enrolled in the study.
Sameer Sabir:And it's a large study. It's, around two hundred and seventy patients, and the study has an active control. So we're comparing Neural ICE to steroid or a single steroid shot, which is a very common treatment that's used today to treat knee pain and all kinds of other pain when it comes to joints. And in this study, we're going to be measuring both pain scores to see how patients fare when it comes to pain after the treatment, but also some functional outcomes as well, because I think pain is certainly an important component of this. But what's probably more important and more relevant to the patient from a day to day standpoint is does that reduction in pain improve their, functional abilities so they can live their lives in a more, wholesome way?
Dr. Moira Gunn:Now these are osteoarthritis patients, so we know that there's pain.
Sameer Sabir:Correct.
Dr. Moira Gunn:Are you looking for people with two knees so you can compare each knee?
Sameer Sabir:Yeah. No. Great question. We we in this study, it's unilateral, so it's only one knee. We're only allowed to enroll one knee at a time as per the protocol that we agreed with FDA.
Sameer Sabir:I can tell you that in our pilot study, there were several patients who wanted both knees done at the same time, but, you know, we believe in, going one step at a time and making sure that everything is shaping up the way we want it to before we, before we, jump to that.
Dr. Moira Gunn:Welcome to science.
Sameer Sabir:Yeah. Yeah. Absolutely.
Dr. Moira Gunn:It's a journey. It's a journey. It's a journey. Sometimes not everyone doesn't get exactly what they wanted out of it. Exactly.
Dr. Moira Gunn:But but at the end, if it all works, they can get their other knee done. So that's that is a good thing. Yeah. That is a very good thing. How long is this trial gonna take if you're for an individual?
Dr. Moira Gunn:I mean, you've gotta get these over 200 patients in and and all of this. How long would a person participate?
Sameer Sabir:Well, we have, we have 11 now, I think, wonderful sites, across The US, who are study centers for us, and enrollment is going quite well. We started the study at the end of last year, we're hoping it'll be fully enrolled actually by the end of this year, which means that we would then there's a six month follow-up period, so we follow the patients for six months after the injections. So our hope is that we can actually go to the FDA for approval, by the middle, or or a little bit later next year in '26.
Dr. Moira Gunn:So, there's a good chance there's gonna be some place near you if there's 11 sites across The US. Yes. How does someone find out about the trial and where they might be able to participate?
Sameer Sabir:Sure. The the trial, information is on Brixton's website, BrixtonBio.com. It's called ICE trial. And you can go to the website and take a look at the details and see if you may, be eligible. And if you are, please reach out to one of the sites that are participating.
Dr. Moira Gunn:Now will this only help knees?
Sameer Sabir:No. So, we actually, founded the company after we spun out from the lab really as a platform technology. We can target nerves wherever they may be in the body. I think the way to think about Neural ICE, which is why it's so interesting actually, is that, if you can identify the nerve that's causing the pain, then you can target that pain using Neural ICE. And so when we started to look at really where the need existed, where the biggest burden on the system exists, it really tends to be, within the musculoskeletal system, and specifically the knee is a big contributor to sort of the global health, the global burden when it comes to pain.
Sameer Sabir:And so we we settled on the knee first, but there are also other joints that we're, interested in and starting to look at. So our second indication that we're looking at is lateral hip pain, and we just very recently started a pilot study in the hip indication as well. And then the third indication that we're interested in is probably the thumb joint. So the thumb joint is a very prevalent, problem, when it comes to osteoarthritis. It affects women about twice as much as it affects men, and is again, you think about using your hand and and and your thumb if that's in severe pain, and that really inhibits your quality of life.
Sameer Sabir:So We're trying to pick indications where there's a real need, there's a lack of real solutions, and also we can we can demonstrate functional improvements in the patient.
Dr. Moira Gunn:Well, Sameer, this has been terrific. I hope you come back and and, see us again and and bring us some some new outcomes. What else we might have learned from all this? And and good luck to you.
Sameer Sabir:Thank you very much for having me, Moira. This has been very cool. No pun intended.
Dr. Moira Gunn:Sameer Sabir is the CEO of Brixton Biosciences in Cambridge, Massachusetts. More information about BrixtonBio and about their ICE trial is available on the web at brixtonbio.com. At the time of this recording, US sites conducting the ICE trial studying injectable cold energy therapy for the management of chronic pain associated with osteoarthritis of the knee are located in or near the San Francisco Bay Area, Houston, Texas, Gainesville, Florida, Atlanta, Georgia, Flint, Michigan, Pittsburgh, Pennsylvania, Boston, Massachusetts, Washington, DC, and several sites in Oklahoma. Recruitment is underway and eligibility criteria for the ICE trial can be found at BrixtonBio.com.
