Actinogen Medical (ASX:ACW) shares went even higher this morning after positive feedback in relation to a pre-Investigational New Drug (pre-IND) submission.

The company is one of the ASX’s few biotechs fighting dementia and like its peers, has gotten a boost from the FDA’s approval of Biogen’s Alzheimer’s drug Aduhelm which was the first of its kind to get the green light.

But Actinogen has also had individual catalysts recently.

The company is planning a study of its Xanamem drug – which blocks cortisol (stress hormones) in the brain – against Fragile X syndrome (FXS).

FXS is a genetic condition causing intellectual and developmental disabilities. It will be a 12-week study of male adolescents starting in the last quarter of this year.

The past few months has seen a new CEO hired as well as clinical research organisations to assist with an upcoming clinical trial in FXS, and Ethics Committee Approval for another planned trial in Mild Cognitive Impairment (MCI).


This morning’s catalyst

Today shares got a further boost thanks to the receipt of feedback from the FDA about the upcoming trial against FXS.

The American regulator told the company its data package and trial design would be sufficient for a formal IND submission, which it plans to file next quarter.

Getting an IND certification is neccessary to start clinical trials in the US. Although this trial will take place in Australia and US IND approval isn’t needed, the company is eyeing off the US market. It hopes things will be easier with the FDA once a trial is complete rather than starting from scratch.

CEO Steven Gourlay said this was a significant milestone in the drug’s development.

“It provides greater confidence that we will obtain support from the FDA for the investigation of Xanamem in this disease that has a high unmet medical need for effective therapies – there are no currently approved therapies for FXS,” he said.

“Actinogen is now positioned to progress its clinical programs with multiple Phase II trials and is well-funded to advance the development pipeline.”

Shares rose by as much as 17 per cent today and are up over 700 per cent in 2021.

Actinogen Medical (ASX:ACW) share price chart