Ann: Neuren completes enrolment in Phase 2 trial in Rett Syndrome, page-2

Neuren (NEU) - ASX Announcement 26 June 2014
Neuren completes enrolment in Phase 2 trial of NNZ-2566 in Rett Syndrome
Melbourne, Australia, 26 June 2014: Neuren Pharmaceuticals (ASX: NEU) announced today that enrolment of subjects in its Phase 2 clinical trial of NNZ-2566 in Rett Syndrome has been completed. This will enable top-line results from the trial to be released by Neuren in the 4th quarter of 2014, as planned.
The double-blind, placebo-controlled trial, initiated in April 2013, is the first commercial multi-site clinical trial in Rett Syndrome, for which currently there is no approved therapy available. The trial has been supported by the International Rett Syndrome Foundation (IRSF) and will be featured at the 2014 IRSF Symposium in the Washington D.C. area, June 24th-26th.
Two dose levels of orally administered NNZ-2566 are being tested in female subjects aged 16 to 45 years. The trial duration for each subject is approximately ten weeks, including the screening and follow-up periods. To date, 47 subjects have completed the trial, with 7 more in progress. The total number of subjects completing the trial therefore may be up to 54.
As well as the primary endpoint of safety and tolerability, a number of different measures will be analysed for signs of clinical efficacy. To date there have been four meetings of the independent Drug Safety Monitoring Committee and no safety concerns have been identified.
Neuren Executive Chairman Richard Treagus commented; “We are pleased to be able to announce that our three clinical trial sites have successfully completed the enrolment of subjects by 30 June as planned. We now look forward to completing the trial and analysing the data to assess the potential for NNZ-2566 to help Rett Syndrome sufferers and their physicians.”