Actinogen Medical (ASX:ACW) Phase II Alzheimer’s trials


by Rachael Jones

Actinogen Medical Limited (ASX:ACW) Managing Director and CEO, Dr Bill Ketelbey provides an update on the company's lead Alzheimer Phase II drug candidate XanADu and its expanded clinical development program for Xanamem.

Rachael Jones: Hello, I'm Rachel Jones for the Finance News Network. Joining me today from Actinogen Medical Limited (ASX:ACW) is CEO and Managing Director Dr Bill Ketelbey. Bill, welcome back to FNN.

Dr Bill Ketelbey: Thank you. Thank you, Rachael.

Rachael Jones: Now Actinogen Medical Limited (ASX:ACW) is a development biotech company that specialises in Alzheimer's and other cognitive diseases. Can you tell me more?

Dr Bill Ketelbey: Yes, so what's been recognised in recent research over the last decade or so is there's a clear association between raised cortisol, now cortisol, to put that in context, that's the stress hormone that we all produce throughout the day, but raised cortisol, persistently raised cortisol in an elderly person is associated with cognitive decline and significantly is associated with the development and the progression of Alzheimer's disease. Our hypothesis behind our research and behind our drug is that if we can inhibit that cortisol production in the brain, particularly in the areas of the brain most affected by Alzheimer's disease, we may well have an impact on the disease and that's the research we are undertaking right now.

Rachael Jones: And now to the XanADu Phase II trial. Can you tell me more about that, starting with the key outcomes?

Dr Bill Ketelbey: So the XanADu Phase II trial is our trial in mild Alzheimer's disease. The outcomes of the trial are the standard outcomes you would expect in any quality development study for an Alzheimer's drug, any regulatory authority or research team, or any commentator speaking on Alzheimer's disease would look for these outcomes that we have in our study. We are progressing incredibly well. We started the trial middle of last year. We've got as of this morning 149 patients on the trial. That's out of a total of 174, so only 25 more patients to go on the trial. So we're making great progress and we'll have results very soon.

Rachael Jones: And what can you tell me about the extended development program for Xanamem?

Dr Bill Ketelbey: So just in the last month or so, we undertook a very successful capital raise. We've brought on board a number of big institutional investors, including Biotechnology Value Fund (BVF) from America, Platinum Asset Management Limited (ASX:PTM) in Australia, Australian Ethical Investment Limited (ASX:AEF). We raised AUD$16.5 million, and what that funding allows us to do is broaden up the data set that we're generating around Xanamem. We've obviously got XanADu ongoing, that's the Alzheimer's trial, but what we wanted to initiate were additional studies, more specialised studies called target occupancy, which measures the specific inhibition of the enzyme in the brain, higher dose safety studies. We wanted to initiate a number of a toxicology studies and to look at additional indications. Now this funding has allowed us to do that. And in fact, we've initiated some of these studies already.

Rachael Jones: What are the market expansion opportunities for that?

Dr Bill Ketelbey: Okay, so within this broadened development program is the opportunity to look at indications other than Alzheimer's disease. The mechanism of action of the way the drug works through inhibiting cortisol in the brain opens up the opportunity for a broader cognitive improvement in a susceptible population, populations that include diabetics, Parkinson's patients, schizophrenia, depressive patients, potentially epilepsy. All of them are associated with raised cortisol and in susceptible populations with decreased cognitive ability. Our hypothesis is that through inhibiting that excess cortisol in the brain, we could improve cognition, so not only in Alzheimer's but potentially in a number of other indications as well.

Rachael Jones: And now let's talk about your financials and to the share price. What is your cash position?

Dr Bill Ketelbey: Okay, so our cash position is actually very strong. In the last month or so, we did a very successful capital raise. Cornerstoned by Biotechnology Value Fund (BVF), a specialist biotechnology fund from San Francisco in the U.S., alongside of Australian Platinum Asset Management Limited (ASX:PTM), and Australian Ethical Investment Limited (ASX:AEF), so three very strong conservative funds specialising in biotech investment came onto the register and in fact reflect three of the four leading shareholders in Actinogen Medical Limited (ASX:ACW).

Rachael Jones: That's excellent news. And are you able to provide a comment on the share price for the last 12 months?

Dr Bill Ketelbey: I think we're in great shape now to begin to see the market recognise the true value of our business going forward as we obviously approach the readout from our Alzheimer's trial in the second quarter of next year.

Rachael Jones: And last question now, why should investors consider adding Actinogen Medical Limited (ASX:ACW) to their portfolios?

Dr Bill Ketelbey: Well, the investment opportunity for Actinogen Medical Limited (ASX:ACW) is very exciting right at this point in time. We've got a novel treatment, novel mechanism of action for treating Alzheimer's disease. We've proved our drug gets across the blood-brain barrier. We've demonstrated in human and animal studies that our hypothesis works and everybody knows how huge and significant and, importantly, unmet the Alzheimer's market is. And at this point in time, we truly believe our business is undervalued by the market, so we've got a great opportunity for investors to come in at this point when we truly believe we're on the cusp of something very big.

Rachael Jones: Dr Bill Ketelbey, thanks for the update.

Dr Bill Ketelbey: Thank you.