Actinogen's Alzheimer's trial gets independent tick of approval; raises $15m

Alzheimer’s drug developer Actinogen is powering forward in its XanADu clinical study, this week announcing the successful completion of its interim analysis as well as a $15 million raise.

XanADu is the company’s randomised, double-blind, multi-centre clinical study comparing its lead drug Xanamem to placebo in subjects with mild dementia due to Alzheimer’s disease. The trial is being conducted at 20 research sites in Australia, the United Kingdom, and the United States. It’s the largest trial of this kind to be undertaken to date by an Australian biotech.

Early safety and efficacy data from the first 50 patients to have fully completed XanADu, as well as safety data from 37 patients currently ongoing, was reviewed by an independent Data Safety and Monitoring Board (DSMB) and given the tick of approval to proceed without modification. The DSMB will conduct a follow-up meeting in three months’ time.

This tick from the DSMB is reassurance that the positive benefit-risk safety profile of Xanamem 10mg daily continues, with no treatment-related serious adverse events reported.

To date, the company has enrolled 100 of 174 patients in the XanADu trial since May last year, well past the half way point reached earlier this year.

“We’re delighted with the recommendation from the DSMB to continue, and it helps build our confidence and optimism in the potential of Xanamem to be an effective treatment of this devastating disease.” chief Bill Ketelbey told the market.

Dr Bill Ketelbey, chief at Actinogen Medical

Alongside that, the company has received cornerstone support from leading US Biotech Investor, Biotech Value Fund (BVF) and other leading Australian institutional investors Platinum Investment Management Limited and Australian Ethical Investment to raise a total of $15 million at 5c a share –a 13.4 per cent premium to its 5-day volume weighted average price.

Under the placement, BVF will be the largest shareholder in Actinogen with 19.9 per cent of the ordinary shares on issue prior to the share purchase plan – what the company says is further validation of its innovative potential.

“While any investment in a disease as prevalent and debilitating as Alzheimer’s disease is high risk, we believe that Xanamem, if successful, offers the extraordinary promise of improving the lives of millions of people worldwide,” BVF founder and general partner Mark Lampert told the market.

“We feel privileged to play a significant role in supporting the company.”

Existing shareholders have been offered a share purchase plan on the same terms – to take the total capital raised to a maximum of $17 million.

The DSMB recommendation also supports the outlook that the statistical expectations of the study’s efficacy endpoints are progressing as planned; this gives Actinogen confidence to progress with further development of Xanamem in other potential indications such as diabetes-related cognitive impairment.

The funds raised will make exploring other potential indications a possibility, as well, the funds will be used to initiate trials to study higher doses of Xanamem.

Unlike other drugs in development for Alzheimer’s disease, Actinogen’s approach has been centred on reducing the levels of the stress hormone cortisol in the brains of people with mild Alzheimer’s – potentially leading to treatment of the symptoms and reducing the progression of the disease.

Dr Ketelbey says he hopes the trial can make an impact on treatment for this devastating disease that has largely gone unchanged for the past 25 years.

“If Xanamem is shown to safely and effectively treat dementia due to Alzheimer’s disease, it would represent a tremendous advance for the treatment of this devastating disease.”

“We eagerly await the completion of the XanADu enrolment before the end of 2018 and reviewing the full dataset in Q2 2019.”

This special report is brought to you by Actinogen.

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