Ann: ACW XanaCIDD phase 2a trial topline results, page-99

Xanameme may not have met its primary endpoint in the recent Phase 2 Trial but the reduction of cortisol has clearly affected depression patients, and in a positive way. This is oiutstanding news for all those holding ACW longer term as clearly the drug provides benefits for those with depressive disorders and excess quantities of the stress hormone in their system.

The key secondary endpoint was the MADRS which is a structured psychiatric interview evaluating MDD symptoms. The MADRS is the commonly used endpoint for major MDD trials and regulatory approvals of anti-depressant medications. Improvements in placebo groups of 20-40% are commonplace. Approved anti-depressants typically report average MADRS improvements of ~2 to 3 points over placebo groups.

Greater Xanamem benefit on MADRS scores was evident in the pre-specified group of 81 patients with less severe depression: at the end of treatment (3.6 points, Cd = 0.88, p = 0.02) and four weeks later (3.6 points, Cd = 0.87, p = 0.03). The large clinically and statistically significant benefits in this responder population are particularly notable and the characteristics of the group will be fully explored to inform future trials

Greater Xananem benefit on MADRS scores was also evident in a smaller pre-specified group of 31 patients taking the drug as monotherapy, that is, without other anti-depressant medication: clinically significant at the end of treatment (4.3 points, Cd = 0.64, p = 0.06) but not four weeks after treatment

Dr Steven Gourlay, Actinogen's CEO said:

"The excellent safety profile of Xanamem was again demonstrated in this trial and the significant treatment benefits seen in depression are encouraging for both the depression and Alzheimer's disease programs. We believe the trial confirms the ability of Xanamem 10 mg daily to safely provide benefit to patients by inhibiting the synthesis of the "stress hormone" cortisol in the brain.

DYOR