For this year’s Summit presentation, Actinogen Medical (ASX: ACW, $0.03) CEO Steven Gourlay was asked by Bioshares to discuss what previous results with the company’s drug candidate, Xanamem, give confidence of a positive clinical trial outcome in its Phase IIb study in Alzheimer’s disease.
In a Phase IIa study in patients with Alzheimer’s disease, a subset with high pTau 181 levels (recently accepted as a biomarker of the disease) showed less decline (p=0.09) on Xanamem compared to placebo, measured by CDR-SB. The difference was 0.62 units, which Gourlay said is better than that achieved with marketed beta-amyloid blocking drugs. He described this as a “very big treatment effect.” This was observed after just 12 weeks of treatment, compared to the slower arrest in decline over 18 months seen with beta-amyloid drugs, which Gourlay noted have borderline risk-benefit profiles.
In a separate Phase II study in 165 patients with depression, Xanamem showed a modest benefit in symptoms, though this may have been masked by a placebo effect. Interestingly, four weeks after stopping treatment, the active arm showed extended benefit with statistical significance, suggesting a potentially durable effect. Gourlay said this was not surprising given the drug’s impact on cortisol in the brain.
A PET imaging study confirmed that after seven days of Xanamem at 10mg/day, patients achieved full engagement of the target enzyme (11β-HSD1) in the brain. Gourlay emphasised this validated the dose selection for the current Phase IIb trial and said this data was one of the reasons he joined Actinogen and invested significantly.
He added that the scientific literature linking high cortisol levels to both Alzheimer’s disease and depression is “enormous.”
On competition, Gourlay noted emerging data with GLP-1 inhibitors (e.g., Ozempic) showing potential in Alzheimer’s disease by reducing inflammation and protecting brain cells, though effects have only been seen in Type 2 diabetes patients so far. Based on Xanamem’s pilot data, he suggested there is a possibility the drug could “halt Alzheimer’s disease completely in a significant proportion of patients,” calling it the Holy Grail.
Partner interest is increasing as the company approaches an interim readout (early next year) and final data (end of 2026). The interim analysis will cover futility and safety from the first 100 patients treated for 24 weeks. Actinogen is seeking regional licensing deals to retain maximum value for shareholders in major markets, with deals possible before final data is reported.
Given the modest size of the Phase IIb study (220 patients), Gourlay cautioned that statistical significance may not be reached across all measures, but he wants to see consistent positive trends.
Regarding mechanism of action, Gourlay said Xanamem shares overlap with GLP-1 drugs in reducing neuro-inflammation and insulin sensitivity problems caused by elevated cortisol, effectively reducing what he called the “chronic stress state of the brain.” He believes this should be disease-modifying. The mechanism does not interfere with beta-amyloid drugs.
Actinogen Medical is capitalised at $94 million.
Bioshares recommendation: Speculative Buy Class B
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