Following last week’s quarterly report, dominated by positive XanaMIA trial results, Actinogen (ASX: ACW) today announced plans to focus on its phase two trials in Alzheimer’s disease and depression.
After reassessing it priorities and planned expenditures, the neurological specialist plans to suspend its clinical trial operations for Fragile X Syndrome - a genetic condition that causes a range of developmental problems including learning disabilities and cognitive impairment - and reallocate resources (forecast to be approximately $12) to:
The Alzheimer’s Disease (AD) and Major Depressive Disorder (MDD) clinical programs for Xanamem, where cognition is the primary focus.
Expedite the XanaMIA Part B Phase 2 AD trial, which will measure safety and cognitive performance in patients with the early stages of AD.
Expedite the MDD Phase 2 trial, which will measure safety, levels of depression and cognitive performance in patients who are inadequately treated by their anti-depressant medication.
Investigate alternative funding, partnership and implementation models to study the utility of Xanamem in people with FXS.
Today’s about face, follows the company’s early February appointment as leading clinical research organisation Worldwide Clinical Trial to manage the implementation of its upcoming XanaFX Phase 2 trial.
It’s understood there are currently no treatments approved anywhere in the world for FXS.
At the commencement of the XanaFX trial, the company described it another important step in the quest to help make a material difference to the quality of life for people and their families living with FXS.
Commenting on today’s announcement, CEO Gourlay notes that results from the Part A trial trigged a review of the company’s priorities for the next two years.
“It makes business and scientific sense to devote resources and capability to our clinical programs focused on cognition, given the XanaMIA data, and expedite the phase 2 trials in Alzheimer’s Disease and Depression,” he said.
“This is clearly now the optimal path to commercialisation of our revolutionary small molecule drug, Xanamem.”
Given that the strong scientific rationale for our Fragile X program hasn’t changed, management expects to be able to study Xanamem in this disease with the help of strategic partners in industry or academia.
In light of recent developments, management’s focus is now on capital-efficient, Australian clinical trial operations for its studies wherever feasible.
Actinogen had a cash balance of $19m at the end of the March 2022 quarter, which will be augmented by annual rebates from the Australian government.
Actinogen shares were down around -6.00% an hour out from the close.
Actinogen share price over six months.
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