Camilla Easter, Oxford Medical Products - Safe, Effective, and Affordable Weight Loss | LSI USA '24

Camilla Easter  0:04  
Camilla, well, great to be here and talk to you all today. I'm Camilla, CEO of Oxford medical products. We have developed a totally novel, non surgical, non pharmacological solution for obesity. So as I'm sure you're all aware, obesity and excessive weight now affects more than 2 billion people worldwide, and it is arguably the biggest public health crisis we are facing up. Until recently, the main state treatment was bariatric surgery, but clearly that's completely unscalable to hundreds of millions, if not billions, of people. And then, as you'll all be aware, as mpik comes along, sort of four or five years ago, and this has really opened up the market. So we're now looking at a total market size of around about 100 billion by 2030 but azempic and tracipatide zetbound from Ali, these are not a panacea. They come with some quite significant side effects, and this is really bore out. When we look at the data, we see that only 25% of individuals are still on treatment at the year mark. And why is this important? Well, obesity is a chronic disease, and you have to, you have to treat it long term. As soon as you stop treatment, the weight comes back on. And we see this, you know, two thirds of weight comes back on after you stop. GLP, one treatment within about a two year period. So what can we do about this? Well, at Omp, we have developed a totally novel solution, as I said. This is non surgical, non pharmacological. This is a pill that you take. It swells rapidly in the stomach. And the best way to think of this is it works just like a gastric balloon. We are taking up that volume in the stomach. What you would see is our pill swelling very rapidly in that solution. And that's really important. We have to swell rapidly so we can stay in the stomach and we continue to work 24 hours a day, seven days a week. Where other hydrogel technologies have failed is that they cannot stay in the stomach. If you're not in the stomach, you are not suppressing appetite. So we are delivered already our pilot trial data that I'm about to go through with you demonstrates we have really good appetite suppression. So we believe we're going to be comparable with the lights of ozempic on our weight loss. And this last part is incredibly important. What goes in comes out. We are not systemically absorbed. We're not going to see those really significant side effects that are stopping people staying on treatment like we're seeing with those GLP one therapies. So as I said, we've completed all our preclinical we've got a great tox profile, and last year we finished our first inhuman trial here. We took 10 individuals with a BMI of 30 to 40, and we did two lots of dosing with them. So we did a low dose and then a washout period for two weeks, and then we did a high dose and then a washout period for a further two weeks. Of course, this was a first in humans, so we're looking at safety first and foremost, and tolerability. But actually what we really wanted to understand is, what effect are we having on appetite, both in the acute phase immediately after dosing, but actually in the chronic phase, when people are just out about in their life. And so we really, really sort of started to focus on that, and we had to understand how's our product working. We're totally novel. No one else has done anything like this. So pleased to announce that we have dosed over 160 of our hydrogels. Now, in those 10 individuals, it's been really well tolerated. And as I said, we looked at appetite in two separate ways. We looked at the acute phase and we looked at it in the chronic so here we've got fullness. So this is the acute phase for up to two hours after dosing. So the gray line that you can see there is essentially our control. That's a large glass of water. Then the teal is one pill, and the dark blue is two pills. So as you'd expect, when people have taken the water after kind of 30 minutes, 60 minutes, that water leaves the stomach and the fullness goes away. That's a totally normal mechanism of action. What you can see when they've taken our pill with the teal and the dark blue is that fullness is dramatically increased and sustained for those two hours. Great. So we know we're getting acute appetite suppression. So at this point, after that, 120 minutes, we said that you guys must be starving. We haven't fed you for 12 hours. We have to be starved to do this testing, go to the canteen right now, they're in hospital, and select what you want to eat and bring it back to us before you eat it. And what we found was when individuals had had two hydrogels on that blue line compared to when they'd had none with the water, they selected 50% less calories on their plate than, as I said, when they just had the water. So we know we are suppressing appetite in that acute phase, but that's great. What happens when you're at home in your real life? And actually, I'm super excited to show that we are able to replicate the same sort of set of data in that environment. So what you've got here in the dark gray is our baseline. The teal, again, is the low dose. We have a washout period, which is the gray line, and then the dark blue, which is our high dose. And as you can see, so the first graph closest to me is hunger. So what we want here is this graph. To go down, and you can see almost a 30% reduction in hunger on our high dose. And as you'd expect, much like the GLP ones, as soon as you stop treatment, that appetite comes back. Okay, so we've got to be treating this as a chronic disease long term, and we need a solution that is safe to do that long term. And when we look at desire to eat. This is, this is super exciting, because it's very comparable to the semiglutide data we see from Novo as we have almost a 50% reduction in a desire to eat, and this is throughout the week, so that's on weeks five and six and continuously. So that trials now complete, we passed all of our safety review committee meetings, and we've now just started enrolling for our extension trial. So here we've got 40 individuals in a randomized, double, blinded placebo control trial. We have 30 people on dose and 10 individuals on placebo, and we'll be treating them for three months. So of course, here now we're taking that information, we're using that how do we dose? People, low dose, high dose, and we'll be looking at weight loss. We'll be using that three month data to submit our IDE to the FDA later this year in order to go into our pivotal starting in the US in 2025 we should have some interim data coming out around about May, June time this year, I said. So further safety. Of course, this is still a first in human but weight loss, weight circumference, glycemic control, blood pressure, et cetera. So we have designed what is a very differentiated approach to weight loss. We are not another incretin hormone therapy in the pipeline. We're coming at this actually, from this bariatric surgery route. We've spoken to FDA, we've done a couple of Q subs. They said you're probably going to be de novo. We want to see that extension trial data before we confirm. But actually, if you guys have the safety profile that you showed us in that initial first in human we'll likely be giving you an indication for use for anybody with a BMI of 25 and over. So the GLP ones currently have an indication if anyone would be above 30 and over or 27 if they have a comorbidity. So this really opens up that part of the market for us. We'll be able to help those individuals who currently don't have any great treatment options available to them in the overweight category, which actually is where the majority of our population sits. And then further to that, Novo and Lily have essentially created a weight maintenance market. So they've got all of these people going on to their therapy. They're then losing some weight, but they're not tolerating it. They either can't, they can't tolerate it, or they actually can't afford it. You know, this is over 1000 bucks a month if you want to continue that for life, that's quite a hefty burden to be taking with you. So what do we do with these individuals? We don't want to take them off treatment. That weight is going to come back on. They've lost all the benefits. Well, we can transition them onto our product, and we are uniquely positioned to really disrupt that part of the weight loss market. So we currently manufacture this all ourselves in the UK. We'll be moving our manufacturing over to the US, probably around 27 we have two patents, two patents granted, and one patent filed. So just quickly before I go on, we were able to show really good gastro retention. So further to our obesity platform, we're now looking, can we deliver drugs with our device? So we're looking at small molecules. We're also going to be looking at peptides as well, and excitingly, specifically, semiglutide, the ribesis, has a 1% oral bio oral bioavailability compared to his mpik, which is an 87 just so happens, semi glutide is absorbed in the stomach, which is where we're going to be keeping it. So we're going to improve its bioavailability, and we're going to have a synergistic compound effect on weight loss. I'm supported by a fantastic team, but I'm super short on time. Hu tan is our bariatric surgeon, and Shui is our material scientist from Oxford. So we are currently raising 25 million that money will be used to run our pivotal trials, as I said, here in the US, starting next year, and takes us all the way through to FDA submission towards the end of 2026 and we'll look to commercialize that first asset in 2027 we'll be looking to close that round on data readout around q3 this year. Thanks. Applause.