Actinogen Medical (ACW: $0.045) has received the green light from the Data Monitoring Committee to continue with its Phase II/III Alzheimer's study following an unblinded futility analysis.
The analysis decoded the data from patients on Xanamem or placebo, assessing the safety and efficacy. The recommendation was to proceed with the trial without alteration. In some cases if low efficacy signals are seen, then the DMC can recommend to increase the size of the study, or if no efficacy signals are observed, then it could recommend to discontinue the study.
The DMC assessed just over one third of the trial data, with partial data from 137 patients and full data from 52 patients who had completed the full 36 weeks of treatment. The last of the 247 patients was recruited into the study last month. The trial started in December 2024.
The company has designed the study to 'augment the ability to detect a Xanamem treatment benefit'. This has been achieved by only recruiting patients likely to be disease affected, specifically, those with elevated levels of the pTau181 biomarker. Following completion of treatment on placebo or Xanamem, patients are offered the option to participate in the open label extension study on Xanamem treatment, which is due to start in March.
Actinogen is now also in the planning for a larger Phase III study with Xanamem in Alzheimer's disease in 2027.
Topline results from the current study are due to be reported in November this year. Actinogen is currently in a trading halt with a capital raise underway. Actinogen is currently capitalized at $143 million.
Bioshares recommendation: Speculative Buy Class B
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