Actinogen’s trial found that patients with elevated blood pTau, above the median value, showed a clinically significant Xanamem effect on the CDR-SB endpoint. CDR-SB will be a primary endpoint in the company’s upcoming Phase 2b trial.
Paul Rolan, chief medical officer at Actinogen stated the results of the trial “are a significant step forward in the development of Xanamem as a new treatment for Alzheimer’s Disease (AD) with a novel, amyloid-independent mechanism of action.”
The findings of the Phase 2a trial validate a clear path for regulatory approval as the company moves forward with clinical research in the AD space.
The Phase 2a trial in biomarker-positive patients used available blood biomarker levels in 72 patients from the company’s prior study, XanADu. The XanADu study had 185 patients with mild AD.
“We are very pleased to see such positive clinical data for patients with biomarker-positive, mild AD. The results extend findings of therapeutic effects on cognition in two prior trials of cognitively normal, older volunteers to patients with early AD,” said Rogan.
A CDR-SB effect of .6 to 8 points represents a 60 to 80 percent reduction in disease progression over 12 weeks compared to placebo. The Phase 2a trial data also showed that 56 percent of patients in the Xanamem group were stable or in improved condition compared to the placebo group.
Additionally, data showed that elevated blood pTau had a clinically significant effect in Neurologic Test Battery (NTB) and Mini Mental State Exam (MMSE).
Rogan explained that the data from the Phase 2a trial validates the dose range planned for Actinogen’s upcoming trials in AD and depression.