Rett syndrome is a severe neurodevelopmental disorder with no approved treatments. Credit: Colin Behrens from Pixabay.

Newron Pharmaceuticals has decided to terminate the clinical development of sarizotan for patients with Rett syndrome after the drug failed to demonstrate any benefit in the STARS study.

The six-month STARS trial enrolled 129 patients at 14 centres across the US, Europe, Asia and Australia. Participants were administered with daily 10mg and 20mg doses of sarizotan or placebo.

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The primary endpoint of the study was the percentage decrease in episodes of apnoea during waking time compared to placebo.

According to top-line data, the drug did not show evidence of efficacy on the primary or secondary variables.

Newron Pharmaceuticals chief medical officer Ravi Anand said: “We are very disappointed that the top-line results in the STARS study did not meet the study endpoints.

“The results of this well-designed and executed study, based on highly promising data from a genetic model of Rett syndrome in mice, indicate the difficulties inherent in translating effects in animal models to human clinical studies.”

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Data from additional explanatory analyses is yet to be made available. The company intends to continue reviewing the full data set from the trial to better understand the results.

The company said in a statement: “Newron plans to work with the Rett research community and families to share learnings from the STARS clinical study, as well as from the Rett Syndrome International Burden of Illness Survey, to further advance scientific and medical understanding of this disease.”

Newron will continue to work on its pipeline and assess more candidates. This is in line with the company’s long-term strategy to develop central and peripheral nervous syste therapies.

The company plans to advance the Phase III clinical programme of  evenamide in schizophrenia in the near future.