Special Report: Emerging Aussie biotechs are just as capable of industry-wide impact as big pharma says Dr Bill Ketelbey, chief of ASX-listed Actinogen.

And Dr Ketelbey would know.

The former Pfizer exec made an unconventional move from the $US220 billion giant to $A37 million Actinogen (ASX:ACW) in 2014.

“While Pfizer‘s a massive multinational, in reality the research and development we’re undertaking at Actinogen is no different. The quality of our drug development is the same, regardless of the company’s valuation,” he told Stockhead.

“The size of a biotech like ours hides the fact that nearly all of our resources are outsourced and spread out around the world.”

At Pfizer Dr Ketelbey was involved in the development of Aricept – a drug that remains the leading Alzheimer’s treatment despite being developed 25 years ago.

Fighting to usurp that title is Actinogen’s novel drug candidate Xanamem, designed to inhibit production of the naturally occurring stress hormone cortisol in the brain.

The challenge to solve Alzheimer’s

The challenge of solving Alzheimer’s was one of the greatest drawcards to joining the company, Dr Ketelbey told Stockhead.

“Actinogen presented an opportunity to work in an area of drug development where there was a huge unmet medical need – and with a drug where the approach was so different from other drugs under development. Approaches that had proven so unsuccessful over the years.”

Most developments in Alzheimer’s treatment are centred on fixing the build-up of an abnormal protein (beta amyloids) in the brain – but recent studies show this may not be the answer, or only part of it.

So far, different is paying off for Actinogen.

Patient recruitment for their landmark Alzheimer’s disease trial is continuing apace and on schedule — just as the research tide is turning to support its cortisol-blocking approach to treating the disease.

The company (ASX:ACW) has enrolled 82 of a planned cohort of 174 patients in XanDAu, their Phase 2 trial of Xanamem in Alzheimer’s disease.

Interim analysis due by mid-year

It has forecast to reach the halfway mark later this month and for an interim analysis of the first 50 evaluable patients to be completed well before mid-year.

“The upside to working at our size is that we are much more agile than big pharma and decision-making and research activity can be implemented so much faster,” Dr Ketelbey said.

“We are substantially ahead of the pack when it comes to research in this area. We have the first mover advantage and if we do demonstrate the benefit of Xanamem in Alzheimer’s disease, we will get to market well before any of the competition.”

Reflecting on his time with Actinogen , Dr Ketelbey describes it as a ‘leap of faith’ when he joined the company.

“At this time I am even more enthusiastic about the drug and the technology, because all the expectations we had for Xanamem have so far proven correct,” he said.

On time, on target

“Early human work showed the drug could get into the brain, early safety work showed the drug was safe. And developing the Phase 2 research program was a huge effort on both our part and our specialist advisory board.”

“We have achieved on time and on target our aspirations for the past 3.5 years and that in itself is a significant feat, something especially unusual in the biotech space.”

Dr Ketelbey will provide an overview of the business and an update on XanADu, it’s Phase II clinical trial of Xanamem for the treatment of Alzheimer’s disease at investor briefings across the country next week.

Click here for more details and to register.

This special report is brought to you by Actinogen.

This advice has been prepared without taking into account your objectives, financial situation or needs. You should, therefore, consider the appropriateness of the advice, in light of your own objectives, financial situation or needs, before acting on the advice.

If this advice relates to the acquisition, or possible acquisition, of a particular financial product, the recipient should obtain a Product Disclosure Statement (PDS) relating to the product and consider the PDS before making any decision about whether to acquire the product.

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