Italy-based Newron Pharmaceuticals has completed patient enrolment in its STARS (Sarizotan for the Treatment of Apneas in Rett Syndrome) clinical study, it was reported yesterday.
The company is likely to report top line results from the STARS study in the fourth quarter of 2019.
The STARS study is being performed in patients who present with clinically significant apneas during the course of the disease. Only patients who experienced clinically significant apnea, ie at least 10 episodes of more than 10 seconds each per hour while awake, qualified for inclusion in the study. The apneas were monitored and recorded using a state-of-the-art medical device providing an objective measure of breathing dysfunction. The recordings were performed over a five to six hour period per day, for three days per week, with the opportunity for patients to repeat the procedure in the subsequent three weeks in case they did not qualify in the first week of screening. During the six-month study, patients who met the eligibility criteria were randomised for treatment with daily doses of 10 or 20mg of sarizotan, or placebo.
The company has reported that treatment with sarizotan has been very well tolerated to date, with a very low rate of discontinuation due to adverse events or lack of efficacy.
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