Key findings from Actinogen's XanaCIDD phase 2a trial

Actinogen Medical (ASX: $ACW) has announced the achievement of clinically and statistically significant benefits in depression with its Xanamem® treatment in the phase 2a XanaCIDD trial. While the trial did not meet the primary endpoint of a cognition 'Attention Composite', Xanamem demonstrated a clinically meaningful and persistent improvement in depression, as measured by the key secondary endpoint of MADRS. The trial results indicate the potential modification of the underlying biology of depression through the inhibition of tissue cortisol synthesis, presenting a completely novel mechanism for the treatment of depression.

Executive Commentary on XanaCIDD trial results

Dr. Dana C Hilt, Actinogen's Chief Medical Officer, expressed optimism about the results, stating, 'This encouraging result on depression is very positive for the whole Xanamem program and confirms 10 mg daily as an active clinical dose with the ability to potentially modify underlying biological processes in the brain. Our on-going XanaMIA phase 2b trial in biomarker-positive patients with mild to moderate Alzheimer's disease continues to enroll and remains on-track to deliver initial results in the middle of next year. I believe the results on acute symptomatic cognitive enhancement in XanaCIDD do not alter the chances of success for Xanamem in Alzheimer's disease where cortisol is implicated in the underlying biology of long-term disease progression reflected as functional and cognitive decline.'

Summary of XanaCIDD trial and future outlook

The XanaCIDD phase 2a trial demonstrated the safety and well-tolerated nature of Xanamem, along with clinically and statistically significant benefits in depression. The unexpected large placebo effect on the primary cognition endpoint may have obscured the drug's potential pro-cognitive effects. However, the persistent anti-depressant effects suggest activity on underlying biological brain processes, providing positive momentum for the Xanamem program. Actinogen's focus remains on the XanaMIA phase 2b trial for Alzheimer's disease, with the company's cash runway supporting its plan through late 2025. The company aims to continue exploring the trial data and potential paths forward for Xanamem in depression, while also expanding its trial sites for the XanaMIA trial to deliver interim analysis by mid-2025.