Breakthrough Alzheimer's pill takes major step towards approval

A once-a-day Aussie wonder drug that could change the way Alzheimer’s disease is treated has reached a significant milestone.

EXCLUSIVE: A once-a-day “holy grail” pill that could change the way Alzheimer’s disease is treated has reached a significant milestone.

In a major development, Sydney-based company Actinogen Medical has made a huge step forward in the development of the drug Xanamem after making an agreement with the US Food and Drug Administration (FDA).

The agreement, which provides clarity on a future US marketing application for Xanamem, is being viewed as a major win and strengthens the Australian biotech’s position in discussions with potential development and marketing partners.

Dr Steven Gourlay is the CEO of Actinogen Medical.

Key outcomes of the agreement include the confirmation of regulatory starting materials for the commercial manufacturing of the Alzheimer’s pill as well as the FDA’s endorsement of a single 10 mg dose vs placebo design for the pivotal trial.

Dr Steven Gourlay, the CEO and managing director of Actinogen, said Xanamem is the first and only drug to test whether you can slow or halt Alzheimer’s disease by lowering tissue levels of the “stress hormone” cortisol, which has long been associated with brain toxicity.

“The new agreement confirms a clear path to approval of Xanamem by the FDA and allows Actinogen to proceed with its planned clinical trials in Australia and globally with confidence,” he said.

Dr Gourlay said the FDA feedback on the Xanamem program was positive and meant that Actinogen had the option to take Xanamem to market with or without other biopharmaceutical partners.”

“Alzheimer’s disease is the leading cause of death in women in Australia and number 2 for men,” he said.

“The reasonable and measured feedback from the FDA on the final stages of the Xanamem program shows that the FDA is keenly interested in safer and more effective therapies for this terrible disease.

“Currently available drugs for Alzheimer’s disease are modestly effective at best, and Xanamem has the potential to be a safer, more effective and more convenient once-a-day pill, which could revolutionise the field.”

The drug, which is currently being trialled across 35 sites in Australia and the US, recently acquired its 100th patient in its trial.

The World Health Organisation (WHO) recently granted Actinogen Medical the nonproprietary name ‘emestedastat’ for Xanamem, and gave it a first-in-class, which Actinogen said was a rare global endorsement that placed Actinogen as one of the most promising players in neuroscience worldwide.

Originally published as Breakthrough Alzheimer's pill takes major step towards approval