Paediatric neurological disorders specialist Neurotech International (ASX: NTI) has received strongly positive results for the double-blind, placebo- controlled Phase II/III NTIASD2 clinical trial for children with Autism Spectrum Disorder (ASD).,
The company is now undertaking further analysis has been carried out on the effect of NTI164 in children who were receiving placebo for eight weeks and then crossed-over to NTI164 from the end of week 8 (beginning of week 9) to week 12 per the trial protocol. In addition, CGI-S information was analysed at week 12 for those patients who were initially enrolled in the NTI164 arm of the trial.
Neurotech continues to see further significant improvements in ASD patients who received NTI164 following the primary end point analysis at 8 weeks as previously reported.
At 12 weeks, NTI164 patients showed a mean CGI-S score of 2.42, representing a 56% improvement from baseline with children re-classified under this scale as borderline ill.
In general, for a CGI-S score of 2, ASD symptoms are present but only just noticeable and not significantly impairing for the child. This is a very significant improvement at 12 weeks for those patients on NTI164 relative to their baseline score of 5.54 (markedly ill), and versus 8 weeks (mildly ill).
Markedly ill patients show significant impairments, needing substantial, consistent support to manage daily life.
“We were curious to understand the immediacy of the benefits conferred by NTI164 in the context of an unblinded clinical trial where patients previously receiving placebo were crossed-over to receive progressively higher amounts of NTI164 over four additional weeks prior to entering the 52 week extension part of the trial,” Dr Thomas Duthy, Executive Director of Neurotech, said.
“The results once again confirm the benefits conferred are drug-related with a rapid clinical onset of improvement. Moreover, patients who have received NTI164 for 12 weeks in total continued to improved following the primary analysis at 8 weeks, so much so their symptoms are barely noticeable. In general this means substantial lifestyle improvements for the patient and their caregivers, which makes us very proud to be supporting these clinical trials in autism.”
