Actinogen Medical (ASX: ACW) has obtained positive topline results for its XanaMIA Part A trial.
Key trial and result features:
- The dose-ranging, Phase 1b trial comprised 107 healthy, cognitively normal, older adults aged 50- 80 years who received 10 mg or 5 mg doses of Xanamem or matching placebo for six weeks
- Assessed cognitive abilities using the internationally recognised Cogstate computerized Cognitive Test Battery (CTB) supplemented by the International Digit Symbol Substitution Test-Symbols (IDSSTS)
- Met primary safety, pharmacodynamic and efficacy endpoints
- Confirms Xanamem’s ability to rapidly enhance attention and working memory, confirming prior findings with a 20 mg dose
- Results are consistent with a prior Positron Emission Tomography (PET) dose-ranging study that indicated dose levels of 10 mg daily or lower are likely to be effective
The company said the trial met its objectives. The efficacy endpoint was defined as clinically significant Effect Size (ES) of Xanamem treatment on cognitive ability versus placebo, measured with well validated tests of attention and working memory from the Cogstate CTB.
Daily Xanamem doses of 10 mg and 5 mg demonstrated a good safety profile and full pharmacodynamic activity supportive of continued development.
The XanaMIA results confirm Xanamem’s ability to enhance cognition even in a cognitively normal population and are consistent with:
1) the prior PET dose-ranging study which found high levels of Xanamem target occupancy at 5 mg and 10 mg daily doses, and;
2) significantly improved attention and working memory tests also seen in the prior XanaHES trial.
“These results consolidate demonstration of the positive effects of Xanamem on cognition, with excellent safety. They are a major boost to our Alzheimer’s Disease program and open the door to Xanamem’s evaluation in other chronic neurological and psychiatric diseases where poor cognition is a significant complaint,” Professor Paul Rolan, Actinogen’s Chief Medical Officer, said.