Actinogen reports Xanamem's significant effectiveness over placebo in depression Phase 2a trial
Actinogen Medical, listed on the ASX under the ticker ACW, has announced significant findings from its Phase 2a XanaCIDD trial evaluating the efficacy of Xanamem in treating cognitive dysfunction and major depressive disorder (MDD). The study demonstrated that Xanamem treatment resulted in clinically meaningful and statistically significant improvements in depression among patients, suggesting that the drug may alter the underlying biology of depression by inhibiting tissue cortisol synthesis—a novel approach for depression treatment.
The XanaCIDD trial, which involved 167 patients with persistent MDD and cognitive impairment, revealed several key findings:
1. Safety and Tolerability: Xanamem was found to be safe and well-tolerated, maintaining a safety profile consistent with previous trials.
2. Efficacy in Depression: The trial's key secondary endpoint, measured by the Montgomery-Åsberg Depression Rating Scale (MADRS), showed that Xanamem provided a greater improvement in depression scores compared to placebo. Clinically significant benefits were observed at the end of the six-week treatment period and four weeks post-treatment. Specifically, in a subgroup of 81 patients with less severe depression, Xanamem showed a notable improvement in MADRS scores both at the end of treatment and four weeks later. Additionally, in a smaller group of 31 patients receiving Xanamem as monotherapy (without other antidepressants), improvements were also observed.
3. Primary Endpoint: The trial did not meet its primary endpoint of improving the "Attention Composite" score based on three Cogstate computerized tests. Both the Xanamem and placebo groups exhibited large improvements, which may have affected the ability to observe the drug's short-term cognitive benefits.
4. Potential for Alzheimer's Disease: The Cogstate Attention Composite is not being utilized in the ongoing XanaMIA Alzheimer's disease trial, which focuses on a broader range of cognitive and functional assessments. The XanaMIA trial aims to evaluate Xanamem's potential in slowing or halting Alzheimer's disease progression, with results expected in mid-2025.
Dr. Dana C. Hilt, Chief Medical Officer of Actinogen, expressed optimism about the results on depression, noting that a 10 mg daily dose of Xanamem appears to be effective in modifying brain processes related to depression. The unexpected placebo effect on cognitive measures may have influenced the trial's ability to detect Xanamem's cognitive benefits.
Actinogen's CEO, Dr. Steven Gourlay, highlighted the trial's confirmation of Xanamem's safety and its potential benefits for both depression and Alzheimer's disease programs. The company's primary focus remains on the XanaMIA Phase 2b trial, which seeks to assess Xanamem's impact on Alzheimer's disease progression over 36 weeks.
XanaCIDD Trial Details:
- Design: Randomized, double-blind, placebo-controlled, parallel group, six-week trial.
- Participants: 167 patients with persistent MDD and cognitive impairment.
- Treatment: Xanamem 10 mg or placebo, either added to existing antidepressant therapy (134 patients) or used as monotherapy (31 patients).
- Endpoints: Primary endpoint was the Cogstate "Attention Composite" test battery. Secondary endpoints included MADRS, executive function cognitive composite, memory function cognitive composite, proportion of responders, and global clinical assessment scores.
Actinogen Medical is focused on developing Xanamem, a compound designed to inhibit cortisol synthesis in brain cells, for neurological and neuropsychiatric diseases. By reducing cortisol levels, Xanamem aims to improve cognitive functions and alleviate symptoms associated with conditions like Alzheimer's disease and depression. The company's ongoing clinical trials are pivotal in determining the therapeutic potential of Xanamem for these conditions.
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