Actinogen Medical Limited (ASX:ACW) Managing Director and CEO Dr Bill Ketelbey provides an update on the company, discussing its lead drug candidate Xanamem, clinical trial roadmap and entitlement offer to raise up to $4.9m.
Rachael Jones: Hello, I'm Rachael Jones for the Finance News Network. Joining me today from Actinogen Medical (ASX:ACW) is CEO and MD Dr Bill Ketelbey. Bill, welcome back to FNN.
Dr Bill Ketelbey: Thank you.
Rachael Jones: Now Actinogen is a drug development company with a special focus on Alzheimer's and other cognitive diseases. What can you tell me about progress?
Dr Bill Ketelbey: Well, we're developing Xanamem, our lead drug, and we've made great progress. We've now got confirmation, after a number of studies we've been running, that our drug gets into the brain. It inhibits the 11beta-HSD1 enzyme, suppresses cortisol, and enhances cognition. And those are the key principles that underpin the development of the drug. So great progress we've made in recent times.
Rachael Jones: And Bill, what can you tell me about the Phase One Target Occupancy study?
Dr Bill Ketelbey: So those design principles that I was talking about, they've come from the target occupancy and the XanaHES trial. Target occupancy's an elegant piece of science that's been run down in Melbourne, where we've demonstrated that our drug gets into the brain. It binds to the enzyme. And by doing that, it then inhibits cortisol and enhances cognition. In developing a drug, working in the brain, it's absolutely key that this is defined and demonstrated, and the Target Occupancy study has done it very elegantly.
Rachael Jones: That's all very encouraging Bill. Now, what can you tell me about the Phase One trial for XanaHES?
Dr Bill Ketelbey: Okay. So this was a 20 milligram safety study. It was designed to demonstrate that the drug can be used safely at 20 milligrams. We showed that. We equally showed that it suppressed cortisol and the cortisol related hormones. But very significantly it demonstrated a cognitive enhancement at 20 milligrams. That to us was a key piece of data, because what it gave us was the confidence that our drug was working exactly as expected, as designed, to get into the brain, suppress cortisol production and enhance cognition. And that was key to the development of our drug.
Rachael Jones: And what does this mean for the development of Xanamem?
Dr Bill Ketelbey: So, the great thing is now, this evidence that we have, if we can translate that now, in patient population groups, because the XanaHES trial was done in a healthy elderly population, but if we can now demonstrate the same in an Alzheimer's population or a Fragile X population, schizophrenia, diabetes population, we have a very, very significant drug and a very significant advancement on the development of cognitive impairment and the treatment of cognitive impairment.
Rachael Jones: And what interest did those results generate?
Dr Bill Ketelbey: So a lot of interest. We obviously presented the data in a number of forums around the world, to the biotech community and to pharma companies. They were hugely impressed because again, as I said, it demonstrated our drug is working the way we wanted it to. What they said to us is, "If you can replicate that in a patient population, we'll find that incredibly compelling." And clearly what we are after, is attracting big pharma to help us develop the drug going forward.
Rachael Jones: So Bill, where's your clinical programs lead from here?
Dr Bill Ketelbey: Okay. So with this exciting information we've got from the XanaHES trial, we're now ready to go into patient populations. The two that we've selected are mild cognitive impairment due to Alzheimer's disease and Fragile X syndrome. Both diseases with minimal therapy or no therapy available for them and both in desperate need of new therapies. We are initiating both trials early next year or in the first half of next year. The Fragile X trial should take about 12 months to complete. The Alzheimer's trial, the mild cognitive impairment trial, will take about 24 months to complete. That data is keenly awaited by us clearly and by our investors. But also by big pharma and the regulators, because both areas, as I said, are in desperate need of new therapies, new, effective therapies to help the patients.
Rachael Jones: That all sounds very positive. Now to finances and strategy. Where is the funding coming from for these trials?
Dr Bill Ketelbey: We're in the middle now of a capital raise. We've undertaken a very successful oversubscribed, $6 million placement. So we have already $6 million. We're now in the middle of a rights issue, a one for five rights issue, in which we're hoping to raise another 4.9 million. That will give us in total 10.9 million, which will be more than adequate to cover the cost of these trials and give us a good runway beyond.
Rachael Jones: Excellent. And where will the funds go?
Dr Bill Ketelbey: They'll primarily be used to fund the Alzheimer's trial, the XanaMIA trial. That's the primary focus of the capital raise.
Rachael Jones: And Bill, who has been backing the company?
Dr Bill Ketelbey: So in this recent placement, a number of institutional investors came on board. But very pleasingly, BVF who's our largest shareholder and has been for a number of years, also came into the placement. So they continue to support us going forward. Our second biggest shareholder is in fact Edinburgh University, which reflects the great science and the legacy that sits behind the development of our product.
Rachael Jones: So Bill, is there anything else you'd like to add?
Dr Bill Ketelbey: So we're at a very exciting point in the development of our company and our drug. In the next few years, we're going to have the results from the Alzheimer's disease trial and from the Fragile X trial. Both of those trials are going to provide very meaningful data for patients and for carers and for the medical profession. But most importantly, for the investors that are supporting us in our venture.
Rachael Jones: Bill Ketelbey, congratulations on your very exciting progress, and thanks for the update today.
Dr Bill Ketelbey: Thank you.