Actinogen Medical Ltd (ASX:ACW, OTC:ATGGF) is advancing two major Phase 2 clinical trial programs using its novel therapy for neurological and neuropsychiatric diseases associated with dysregulated brain cortisol.
Enrolment continues to track well in Actinogen’s six-week XanaCIDD Phase 2a depression clinical trial at Australian and UK sites, which now exceeds 75% of the planned 160 trial participants.
This XanaCIDD study aims to investigate the safety and efficacy of Xanamem drug substance in patients with cognitive impairment associated with persistent major depressive disorder (MDD).
Results for this trial are expected in Q2 CY2024.
Meanwhile, trial site activation and participant screening have started in the XanaMIA Phase 2b Alzheimer’s disease trial.
Treatment of the first of 100 participants at Australian sites is expected to begin shortly. Final results are expected in H2CY2025 with an interim analysis due in H1CY2025.
Priority is to deliver high quality results
Actinogen CEO and MD Dr Steven Gourlay said: “The clear priority for the next 18 months is to deliver high quality results from our two Phase 2 clinical trials.
“We continue to make excellent progress recruiting participants for our XanaCIDD Phase 2a trial in patients with cognitive impairment associated with persistent major depressive disorder (MDD).
“Enrolment in that trial now exceeds 75%, and final results are expected to read out in Q2 2024.
“The first patient in the XanaMIA Phase 2b trial is due to be treated shortly, with initial results in the first half of 2025.”
Next steps
Actinogen is confident about its prospects in FY2024 and beyond and believes that it has successfully mitigated many drug development risks for the program, including regulatory, manufacturing, non-clinical and clinical risks.
The company’s manufacturing, regulatory, clinical pharmacology and nonclinical planning and activities continue in high order to enable rapid expansion on successful Phase 2 results.
Actinogen has already completed the development of an improved synthetic process of Xanamem drug substance and manufacture of a 1kg demonstration batch as a prelude to larger scale manufacture.
The company is well funded with $11.47 million in cash as at 31 December 2023 after completing a successful $10 million capital raising in September.