Although data analysis is ongoing, the early conclusion is that the placebo rate could have been higher in the study due to a slight imbalance in disease severity at baseline, across the treatment arms, and the 2 to 1 drug to placebo randomization ratio. We intend to further assess the collective results and discuss with the regulatory authorities next steps.”
When looking at other placebo-controlled Rett syndrome trials, ANAVEX®2-73 compares favorably in terms of absolute RSBQ improvements, with the caveat that cross trials comparisons have their limitations.
We know the RSBQ improvement for trofinetide was -4.9, while blarcamesine yielded a -12.9 improvement. In fact, the RS-003 placebo improvement of -8.3 beat trofinetide. That's absolutely amazing! Are you getting this?