Marc Giroux - Kurve Therapeutics, Private Partnering Interview at LSI USA ‘23

Transcription

Marc Giroux  0:06  

My name is Marc Giroux. I'm the founder, chairman and CEO of Kurve Therapeutics. We do central nervous system, drug delivery and treatment. The hypothesis of getting drugs into the brain through the nasal cavity was first put forth in the early I mean, in the late 80s. It was not until we came along that it actually became successful or even possible. The problem was the anatomy and the inherent problems inside the nasal cavity that didn't allow access, we solved that problem and got the drugs to the olfactory region. And now we have direct access into the brain. Well, we don't have to worry about the blood brain barrier that the infusions do. So we have currently solved that problem, we are in process now with more than 16 products in the pipeline for nose to brain drug delivery, three of which are phase three, ready. So we've done phase one, phase two, and phase two B with the FDA. And we have hit our endpoints and separated from Placebo, which is really important and why we're a significant player in this space. But we also got 3,000% More in the brain than an infusion did. So we have tremendous dose flexibility, so that we can actually help the patient be safe, as well as get the efficacy of the treatment. So it's a much better offering to the patient and to the medical community than it is then what they have presently. And the biggest problem that they have presently, is that that the crossing of the blood brain barrier so difficult, that they have to put a highly toxic dose in there. So that the brain doesn't react well. And some of them are causing a lot of brain bleeds, we don't have any of that. So not only can we make it better efficaciously. But we can actually make it much safer. We bet we've have a really, really strong safety profile. We're delivering insulin directly to the brain in seven different trials. In those trials, we haven't had a single adverse event. So we're not only is the nasal mucosa not being affected, but the olfactory region is very durable, and it's passing things through. We're using probably 12 or 13 different formulations right now. Some of them are proteins, peptides, monoclonal antibodies, polyclonal, antibodies, all of them remain intact, all of them into the brain. Recently, we've done stem cells with an oncolytic virus that shrunk a brain tumor by 50%. So we're able to get very large products into the brain from the nasal cavity that were considered here to for impossible. We have 16 pipeline products, so anywhere from monoclonal and polyclonal oils, neuro peptides, we have proteins, we've done combination products, we've done as many as four drugs in a single dose into the brain took care of a brain tumor that way as well. So there's really nothing we've been asked to deliver that we could not. So we've been tested. And it's been independently verified by other labs, the molecule leaves the device intact, and we get it in the brain. It's pretty good partnership. We consider it to be the future we do. There's there's 600 neurodegenerative diseases, admittedly, most of those are orphans. But there are orphans that can use our therapy. So we just want to partner with as many as we can, we're going to do probably four to six products with a curve label on it, the other 10 Working out license, but then after those 10 is another 100 that we can do. So as a single company, no single company is going to launch 100 products in a timely fashion, right. So we need to help these people right now. So we had an autism patient say their first words at age 15. We've had PTSD patients just lower that waterline, and now they're safe to be around traumatic brain injury as well. With the DOD, it's been really, really rewarding and not something that you can take lightly. It's actually quite humbling when a patient who was wheelchair bound and couldn't talk anymore, stands up, walks over to you and says Hi, that's that happened to me on the Zoom and it was really powerful. You know, the husband was crying his eyes out. It's an emotional time, it's actually really rewarding. It's nice. If we had money for the phase three, we would feel a little better. This is the device that we're moving to for phase three. It's small and light and quiet. That's it running. It's going to be very, very efficient for the patient. This comes prefilled they will when it runs out, you just get rid of it and you put a new one on. Even if you're dexterously challenged like a lot of our Parkinson's patients and Alzheimer's patients are it's still something they can do. It's really simple. Okay, so when you when you're done with it, you just throw that out, put a new one on. And effectively, we're partners now with the patient, they're going to, all they have to do is maintain this piece, which will last minimum 10 years. And then they're just replacing the contract. So we're not going to make them buy a device really often. Because what we ideally want is a treat more than one condition with more than one cartridge, right? So it's pre programmed, it has a lot of electronics in it, you use it for as long as the motors running, and then you just switch sides do the other for Alzheimer's, this thing takes 48 seconds a day to treat Alzheimer's, right 24 seconds in the morning, 24 seconds in the evening, and the whole machine is kept in the fridge. So basically, what we tell the patients to do is just stand there in front of a refrigerator and just use it and put it right back. That's it when it's empty, chuck it pop into and on. It's very simple, very small, very quiet, very discreet. And if your verbal fluency short term memory and attention span starts to return, it's not something you're gonna give up. Well, we're doing a Regulation A plus raise, plus, we're also trying to do some reg D. But what we really need is money to do the phase three, were one clinical trial from launch. So what we want to do is do the final phase three, get it on the market. And then there's a lot of other things we can do. But there are caregivers and patients out there right now where time is not their friend, right? They're going to progress. So if we're three years launch, that's three years they go down the road, so we have to be able to make it available to them right now. Well, we can do that. So if you're a caregiver, you have a patient, you're a patient or you have a loved one with it, contact us that curve, and we will help you out we can actually get you access to the technology ahead of a clinical trial or we can get you into a clinical trial. So what we want to do is really have an impact on the patient and the caregivers lives. The caregivers lives are miserable, right? They're taking care of a loved one, it's unpaid caregiving, most of the time, two thirds of them are female, and sometimes they're taking care of an in law, right. So it's just a burden $257 billion in lost productivity and Alzheimer's alone, just unpaid caregiving, we need to relieve that stress, and we can put that energy back into the economy rather than siphoning it off. So we're working with the FDA. We're working with the NIH. We're working with the DOD. And we're working with caregivers and patients on a daily basis. Locally here in Newport Beach, California. We have 150 patients that are on this on a compassionate use basis. We talk to every day, we get a chance to interact with the patient, how are they doing? Are they sliding? Are they getting significantly better? And we have some patients walking around this building right now just to do testimonials for us. Because they're you know, thank you for having me back. My Dad, thank you back, my wife, those kinds of things. Those are the kinds of stories that kept us going when you know, money was tight and clinical trials are expensive, but we were making a real impact on the patient and the caregivers and they were like just, you know, so excited about it that we couldn't stop so we stuck with it and now we're here at you know the eve of phase three, we just need the money.