Newron Pharma decimated as sarizotan misses endpoints

Italian CNS-focused drug developer Newron Pharmaceuticals’ (SIX: NWRN) shares plummeted more than 68% to 1.98 Swiss francs by early afternoon trading, after it said it was abandoning development of its Rett syndrome candidate.

Newron today revealed that top-line results from its STARS clinical study evaluating sarizotan in patients with Rett syndrome did not demonstrate evidence of efficacy on the primary or secondary efficacy variables. Consequentially, Newron has decided to terminate this development program.

The STARS (Sarizotan for the Treatment of Apneas in Rett Syndrome) clinical study qualified and enrolled 129 Rett syndrome patients inc14 centers throughout the USA, Europe, Asia and Australia for the six-month clinical trial. Patients received treatment with daily doses of 10mg and 20mg of sarizotan, or placebo. The primary endpoint of the STARS study was a percentage reduction in episodes of apnea during waking time compared with placebo. 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.