Rick Pauls, President & CEO OF DiaMedica Therapeutics, joins Cheddar Innovates to discuss a new ischemic stroke treatment option that expands the window for effective therapy for stroke patients.

Cheddar Innovates

Innovation in Stroke Therapy and Treatment Options

Welcome back to cheddar innovates brought to you by Curiosity stream when it comes to treating a stroke. The window of time is critical without proper and timely treatments, patients can have irreversible side effects. Our next guest is testing a new approach for a skeptic stroke treatment which hasn't seen a new therapy in 25 years. Joining us now is rick pauls president and Ceo die America therapeutics rick. Glad to have you on this morning. Can you just walk us through this new treatment? Sure. Great. It's a pleasure speaking with you today. So first off we're developing a treatment option for patients who've had an acute ischemic stroke. So this is the result of a blockage of the blood flow in the brain which can cause severe and permanent damage to patients. So our treatment objective here with our protein called d. m. 29 is to restore the levels of this protein Called K. L. K. one And importantly as we age, our body's ability to produce this protein decline. So in particular after about the age of 50 patients lose the ability to make this protein which is associated with the risk of having a stroke and also a recurrent stroke. So we've been able to do is manufacture a synthetic protein Called K. L. K. one. And this protein plays a critical role in releasing two very important hormones called nitric oxide and prostaglandins and it releases these hormones locally to when and where it's needed to help to improve these patients stroke outcomes. So by restoring the natural ability to regulate the blood flow. And importantly in patients who've had a stroke, we think we can actually have a treatment option in helping to reduce and minimize the amount of brain tissue dying from lack of oxygen and other nutrients that are that are critical in patients in particular following a stroke. So what is really unique about our therapeutic approach here is that there's actually a form of this K. L. T. One protein extracted from human urine that's actually been successfully treated, been treating patients for over a decade in asIA. And so we estimate over 100,000 patients have actually been treated being treated each year. So with our synthetic D. N. 99 protein, we see a pathway with an analogy to insulin. And so as many of us know that insulin was initially sourced from pig pancreas to treat Type one diabetics. Um and then later on Genentech made the synthetic form to replace all the animal sources of protein. When we look at a stroke, there's obviously a very timely component to treating the stroke. Can you talk about the critical window of time and why it is so critical? Yeah I mean sometimes I say you know, time is is you know brain is time. And so today you know there is an effective treatment called T. P. A. Um but the challenge is that the patient needs to get to a hospital, they need to receive a cT scanner M. R. I. To confirm the strokes and ischemic stroke and not to bleed. And then they have to be treated within 3-4 and a half hours following the onset. So because of this very small window, we believe less than 10% of patients are actually being treated today with T. P. A. So with our D. 99 is being studied to have an initial treatment window of 24 hours where we feel most patients can actually get to the hospital and get treated and if our phase three is successful um you know this is gonna be a treatment option that you know, 80% of patients today who don't have an option could actually be treated. You kind of touched on this there but let's dig into a little bit more. How does this new approach that you're talking about really compare to to kind of the normal treatment that we see with stroke treatments? Sure. So the currently approved pharmaceutical treatment I mentioned T. P. A. That dissolves the plot. Um It has this very small window of 3 to 4.5 hours, as I mentioned a few minutes ago. There's also a device based treatment called mechanical through em back to me. This is a procedure where doctors attempt to physically remove the clot using a catheter. This treatment is limited to a smaller number of strokes that have the blockage occurring large vessel arteries that's blocking blood flow to the brain. So in terms of your treatment and proposal, how far are we in terms of getting that treatment approved by the FDA? Sure. So we're currently in a pivotal Phase two Celester trial which we hope will support an application for approval. So we plan to perform an interim analysis next year with our protein that will allow us to check for the performance of the drug and adjust the study size is necessary. And then we hope to then complete the trial full study in 2024 and then moved to FDA approval. How do you think this treatment if it's actually if it actually gets the approval will impact the broader kind of stroke therapy market? Yeah. So there are some you know in addition to the T. P. A. And the mechanical from me that I mentioned, there are some new reforms of T. P. A. That are in development. Um something which we see our DM nine mechanism of action would actually be complementary in terms of helping to increase the cerebral blood flow. And then in addition I mentioned the mechanical from ectomy, there's new new different products that are also in development. But today, you know, we see about 20% of patients are being treated. So we see with our synthetic protein here the potential to treat, you know the 80% of patients that today just you know, they did not have a treatment option in terms of the broader treatment space for strokes. What other innovations are you watching closely? Yeah. So the main ones really as I mentioned is the is the new forms of T. P. A. And new ways of uh going a little bit deeper down the artery with with with mechanical from back to me and for both of these treatment options. And we think that our recombinant protein could actually provide an incremental benefit for these patients. Yeah, I imagine, you know, for someone who is worried about a stroke or has had a loved one that has dealt with the stroke. The idea that there are newer and advanced treatments coming to market potentially is really a sign of hope for so many who have dealt with unfortunately having a stroke before I let you go here. Just curious what's next for dia medical therapeutics. Sure. So our primary focus today is executing on our pivotal trial that's phase two slash three. So initially to reach the interim analysis next year and then to complete the study in 2024 then to get these patients to patients. So we're fully committed to and focusing on bringing this program to the millions of patients around the world who has who are having a stroke each year and don't have a treatment option. And we see this as simply restoring the levels of this protein in deficit um to helping to improve the stroke recoveries and and reduce the risk of these patients having a recurrent stroke. How much luck to you on that journey? Hopefully you do get that their approval and we see progress when it comes to stroke patients, Rick pauls, president and Ceo of Dia Medica therapeutics.