ACW pharmacokinetics trial success
| Stock | Actinogen Medical Ltd (ACW.ASX) |
|---|---|
| Release Time | 26 Aug 2025, 10:41 a.m. |
| Price Sensitive | Yes |
Actinogen trial confirms target exposures for Xanamem
- Trial shows intended commercial Xanamem tablet formulation produces consistent and therapeutic blood levels
- Xanamem exposures and half-life similar in fed and fasted states, supporting 10mg once daily dosing
- Data supports ongoing XanaMIA Phase 2b/3 trial in mild to moderate Alzheimer's disease
Actinogen Medical announced that a recent trial designed to confirm therapeutic blood levels of the intended commercial tablet formulation of Xanamem, given both with and without food, demonstrated the expected blood levels or 'exposure', comparable with prior studies of a capsule formulation. This indicates that 10 mg once daily remains the target therapeutic dose for the clinical program. The trial was conducted at the CMAX clinical research centre in Adelaide, where 16 individuals were studied on two occasions, one week apart. Each received a 10 mg tablet of Xanamem once while fasting and once after a high fat meal. Blood levels of Xanamem were then measured frequently over the ensuing 48 hours. Key results include the median time to maximum blood concentration of 4 to 6 hours (4 hours fasted, 6 hours after a high fat meal), and very similar Xanamem exposures (area under the concentration-time curve) and elimination half-life of 15 hours in both fed and fasted situations. Professor Paul Rolan, Actinogen's Clinical Pharmacologist, commented that the trial confirmed the intended commercial formulation of Xanamem produces consistent and therapeutic levels in the blood that are similar when given with or without food, giving full flexibility for dosing. These data support the use of the 10 mg daily dose irrespective of food intake in the ongoing XanaMIA phase 2b/3 trial in people with mild to moderate Alzheimer's disease.