Newron Pharma Reports Phase 3 STARS Trial of Sarizotan in Rett Syndrome Fails to Meet Endpoints; Company to Terminate the Program

Newron Pharma Reports Phase 3 STARS Trial of Sarizotan in Rett Syndrome Fails to Meet Endpoints; Company to Terminate the Program

Newron Pharmaceuticals announced that top-line results from its phase 3 STARS clinical study evaluating sarizotan in patients with Rett syndrome did not demonstrate evidence of efficacy on the primary or secondary efficacy variables. As a result, Newron has decided to terminate this development program. 

The STARS (Sarizotan for the Treatment of Apneas in Rett Syndrome) clinical study enrolled 129 Rett syndrome patients throughout the US, Europe, Asia and Australia for the six-month clinical trial. Patients received treatment with daily doses of 10 mg and 20 mg of sarizotan or placebo. The primary endpoint was a percentage reduction in episodes of apnea during waking time compared with placebo. 

Newron has not yet released specific details but did indicate it plans to work with the Rett research community and families to share results from the trial, as well as from the Rett Syndrome International Burden of Illness Survey.

“We are very disappointed that the top-line results in the STARS study did not meet the study endpoints”, said Ravi Anand, M.D., Chief Medical Officer of Newron.” The results of this well designed and executed study, based on highly promising ...

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