The company will use data from a particular subgroup, which showed benefit on a secondary endpoint to form the next trial. Image credit: Shutterstock / VZ_Art.

Australia-based Actinogen Medical’s stocks have fallen by 60% after the company announced a Phase IIa trial of its lead candidate in major depressive disorder (MDD) failed to meet the primary endpoint.

The company’s stock closed at $0.076 on 9 August, when the market opened on August 12 it had already fallen to $0.03, a 60% decrease before falling to a low of $0.025. Overall, a 67% decrease from the previous day’s closing price.

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The Phase IIa XanaCIDD trial of Xanamem (NCT05657691) failed to meet the primary endpoint of “attention composite” in any of the three Cogstate computerised tests measuring attention and working memory with similar and large improvements in performance observed.

The data did show clinically and statistically significant benefits in Montgomery–Åsberg Depression Rating Scale (MADRS) depression score improvement after six weeks of treatment with Xanamem. It had a particularly notable improvement in patients with less severe depression, with Actinogen Medical saying it will look at this data as it shapes future trials.

Other secondary endpoints are still being evaluated include function cognitive composite, memory function cognitive composite, proportions of responders and global clinical assessment scores.

The drug was safe and well-tolerated with a promising safety profile consistent with prior trials.

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The Phase IIa proof-of-concept trial evaluated xanamem, or a placebo, in 167 patients with persistent MDD and measurable cognitive impairment at baseline.

Actinogen Medical is also evaluating the drug in Alzheimer’s disease, with the company adding that the missed primary endpoint of Cogstate Attention Composite from the MDD trial is not used in the ongoing Phase IIb XanaMIA trial (NCT06125951), with data from this trial expected in 2025 and 2026.

In XanaMIA, key endpoints focus on a broader range of tests validated in the Alzheimer’s field, including a seven-point cognitive composite, the Clinical Dementia Rating Scale – Sum of Boxes functional scale and the Amsterdam Activities of Daily Living scale.

Xanamem acts as an 11beta-HSD1 inhibitor, which prevents the conversion of cortisone to the active hormone cortisol that activates glucocorticoid receptors. Increased cortisol levels can lead to irreversible memory loss, increased amyloid plaques and neurofibrillary tangles in the brain.