Actinogen discusses Xanamem Phase 1 results


by Natalie McDonald

Transcription of Finance News Network Interview with Actinogen Limited (ASX:ACW) Managing Director and CEO, Dr Bill Ketelbey
Natalie MacDonald: Actinogen Limited (ASX:ACW) is a biotechnology company, which focuses on the development of novel treatments for Alzheimer’s disease and other major age-related neurodegenerative diseases. I’m Natalie MacDonald and joining me at the CEO Sessions in Brisbane is the company’s Managing Director and CEO, Dr Bill Ketelbey. Bill, welcome back to FNN.
Dr Bill Ketelbey: Thank you Natalie.
Natalie MacDonald: Can you start firstly by introducing Actinogen?
Dr Bill Ketelbey: Actinogen’s a biotech start-up that acquired a very interesting compound from Edinburgh University at the beginning of the year. This is a molecule that’s being developed for Alzheimer’s disease, importantly for early Alzheimer’s disease, and is just about to go into the Phase II definitive trials, in early Alzheimer’s.
Natalie MacDonald: Can you give us an example or tell us perhaps in layman’s terms, how Xanamem works?
Dr Bill Ketelbey: So what’s been discovered over a number of years now is that an increase in cortisol, cortisol’s the normal stress hormone, an increase in cortisol over time becomes pathological. What’s been discovered is you get memory loss, which is one of the symptoms of Alzheimer’s disease. Significantly you also get a build up in the beta-amyloid plaguing in the brain, so this is the abnormal protein build up in the brain. You also get nerve death and shrinkage of the brain.
So all of this occurs in an elevated cortisol environment. What we’ve discovered is if you inhibit that cortisol, and our drug is designed to do just that, if you inhibit the cortisol, you can reverse those symptoms. So reverse the memory loss, stop the amyloid build-up in the brain and even stop the nerve death, and the brain shrinkage.
Natalie MacDonald:Now Actinogen recently completed Phase I of clinical trials. Can you tell us more about this?
Dr Bill Ketelbey: So the Phase I series of trials is a normal development process of any drug. Significant to our series of Phase I trials, was a trial specifically to show that our drug gets across the blood brain barrier. Now that is obviously fundamental to a drug that works on pathology in the brain, we were able to show that. It gets across in more than adequate concentrations to be able to actively inhibit the enzyme in the brain, the HSD enzyme in the brain that is the cause, or the enzyme that produces the cortisol. Particularly in the frontal cortex and hippocampus of the brain, the two areas of the brain that are most affected by Alzheimer’s disease.
Natalie MacDonald: So Actinogen is now preparing for Phase II of the trials in 2016. What sort of size and length will the trials be?
Dr Bill Ketelbey: After we finished all the Phase I trials, the definitive trial, the proof of concept is to use our drug to go into a patient population, with the disease. So we’ll be doing a trial in early Alzheimer’s patients, starting in the second quarter of next year. It’ll be a trial of about 200 patients; it’ll be done in Australia, the UK and the US. So it’ll be done under an IND by the FDA and it’ll be in early Alzheimer’s, and importantly, be a definitive proof of the efficacy of our product. This trial should complete round about the end of 2017, early 2018.
Natalie MacDonald: What then are some of the key outcomes as such that you’re looking to confirm with this trial?
Dr Bill Ketelbey: Really the outcome, the key outcome in any Alzheimer’s trial, is looking to what it does to memory. That is the one symptomatic end point that all Alzheimer’s drugs are tested under. So we’ll be doing that with our drug. At the same time though, we’ll be testing for disease modification. So this is to assess whether our drug can modify the underlying pathology of the disease and in this instance, I’m talking about decreasing the protein build-up, the amyloid protein build-up. If we can show that as well, then we’ll have a dual mechanism of action.
So symptomatic benefit on the memory, as well as a disease modification impact on the protein build-up, in the brain. If we can show that in humans as we’ve already shown in our animal models, if we can show that in humans, we really have a very substantial development and enhancement on current Alzheimer’s therapies.
Natalie MacDonald: And once underway then, when can investors expect updates?
Dr Bill Ketelbey: This is a double-blind trial, so results aren’t going to be available throughout the trial. They’ll only be available at the end of the trial, when we break the blind. But there will be regular updates over the life of the trial, as patients are recruited, as we get closer towards the end of the trial. There is an interim analysis that’s going to be done in the middle of the trial. That will define whether we can stop the trial early, or whether we need to continue to recruit to get an adequate number of patients, in the trial. But really, the definitive results will only be available at the end of 2017 early 2018, when we do break the blind on the trial.
Natalie MacDonald: Let’s take a look then at your FY15 results. What were some of the highlights and are you fully funded?
Dr Bill Ketelbey:We did a very successful capital raising in May this year. We have adequate funds now to run this trial through to the end. Successes in 2015 included finishing off the Phase I trials, finishing off all the animal trials that we had to do, all the laboratory trials we had to do. Get the manufacturing up and running, recruiting all of the service providers, the research and regulatory providers that are going to help us. This huge team that’s going to help us initiate the trial and run the trial, over the next two years.
Natalie MacDonald: Last question then Bill. Where do you hope to see Actinogen this time next year?
Dr Bill Ketelbey: Okay so this time next year, we’re going to be up and running. The trial’s going to be in full swing, we’ll have a clear idea of the trajectory, the patient recruitment trajectory. We should have most trial sites up and running. We would hope all three geographies will be up and running. So we’ll have a much clearer idea I guess, but we will have a good idea of when the trial will be fully recruited.
Natalie MacDonald: Bill, thank you so much for the update.
Dr Bill Ketelbey: Cheers, thank you.