Newron expands enrollment in Phase II/III for Rett syndrome

Newron Pharmaceuticals S.p.A. (SIX:NWRN) expanded enrollment to include patients with Rett syndrome ages ≥6 in the double-blind, placebo-controlled, international Phase II/III STARS trial evaluating once-daily 10 and 20 mg sarizotan for 24 weeks. The trial is enrolling about 129 patients and previously limited enrollment to patients ages ≥13. The company expects top-line data from STARS in 2018.

The trial’s primary endpoint is reduction in episodes of clinically significant apneas during waking time by 20%. Secondary endpoints include caregiver-rated Impression of Change (CIC), safety, time spent with breathing dysrhythmia per hour, number of hyperventilation episodes, oxygen saturation, Respiratory Distress Index, Clinical Global Impression of Change (CGI-C) and caregiver burden...