Actinogen Medical's Xanamem Shows Promise in Treating Depression - 12 August 2024
ACW (ACW) Share Update August 2024 Sunday 11th
Actinogen Medical Announces Promising Xanamem Results in Depression
Actinogen Medical Limited (ASX: ACW) has announced promising results from its phase 2a XanaCIDD trial, showing significant benefits of Xanamem in treating depression, although it did not meet the primary endpoint for cognitive improvement.
Instant Summary:
- Xanamem showed clinically and statistically significant benefits for depression.
- The primary endpoint of cognitive improvement was not met due to large placebo effect.
- Xanamem was safe and well-tolerated.
- Significant improvements in depression were observed in patients with less severe depression and those using Xanamem as monotherapy.
Trial Overview
Actinogen Medical's phase 2a XanaCIDD trial aimed to assess the efficacy of Xanamem in patients with cognitive dysfunction and major depressive disorder (MDD). The trial included 167 patients and was designed as a randomized, double-blind, placebo-controlled study.
The primary endpoint was to measure cognitive improvement using the Cogstate 'Attention Composite' test. However, the trial did not meet this endpoint due to unexpectedly large improvements in the placebo group.
Key Findings
Despite not meeting the primary endpoint, Xanamem showed significant benefits in treating depression, as measured by the Montgomery-Asberg Depression Rating Scale (MADRS). The results were clinically and statistically significant, particularly in patients with less severe depression and those using Xanamem as monotherapy.
In the overall study population, Xanamem showed a trend toward benefit at the end of treatment and a significant benefit four weeks post-treatment. In patients with less severe depression, significant improvements were observed both at the end of treatment and four weeks later.
Safety and Tolerability
Xanamem was found to be safe and well-tolerated, with no significant safety issues observed during the trial. The safety profile was consistent with prior trials, and no serious adverse events related to Xanamem were reported.
Implications for Future Trials
The trial results are encouraging for the ongoing XanaMIA phase 2b trial in patients with mild to moderate Alzheimer's disease. The evidence of durable benefit on depression supports Xanamem's mechanism of action at a 10 mg daily dose.
Actinogen plans to further analyze the trial data and consult with depression experts to determine the next steps for the depression program.
The positive results for depression could boost investor confidence in Actinogen Medical's Xanamem program. Although the primary endpoint for cognitive improvement was not met, the significant benefits in depression and the excellent safety profile are promising for future trials. This announcement could lead to increased interest and potential investment in the company's ongoing and future clinical trials.
Investor Reaction:
Analysts are likely to view the results positively, especially the significant benefits observed in depression. The safety and tolerability of Xanamem further strengthen its potential as a treatment for neurological and neuropsychiatric diseases. However, the inability to meet the primary cognitive endpoint may lead to cautious optimism among investors.
Conclusion:
Investors should keep an eye on Actinogen Medical's future announcements and the ongoing XanaMIA phase 2b trial. The promising results in depression and the excellent safety profile of Xanamem highlight its potential as a novel treatment for various neurological conditions. Actinogen's strategic response and further data analysis will be crucial in maintaining investor confidence.