Marinus restarts phase 3 seizure trials after stability, COVID delays

Marinus Pharmaceuticals is restarting its phase 3 seizure clinical trials that had been delayed by clinical supply disruptions and the COVID-19 pandemic.

The company has resumed screening and recruiting for the trials and expects top-line results in the second half of 2023, a year later than its prior target of the second half of 2022. Marinus said it continues to work on expanding the number of trial sites in the U.S. and Canada and currently has more than 50 sites activated.

The company hit pause on the study in February due to issues related to monitoring stability of batches of the study drug—its intravenous formulation of the GABAA receptor modulator ganaxolone. What Marinus found led the company to cut the shelf-life to 12 months, half the previously expected 24 months. Marinus made the change to meet product stability testing specifications. 

“In agreement with the U.S. Food and Drug Administration, ganaxolone clinical supplies will be stored under refrigerated conditions for the entire duration of clinical use,” the company said in a statement.

Marinus added that it will likely modify the IV ganaxolone formulation with a new buffer by end of the third quarter of 2022 with the aim of achieving a shelf-life of at least 24 months.

Marinus’ phase 3 intravenous clinical trial began just as the U.S.’ second COVID-19 wave was starting in the fall of 2020 and has since contended with subsequent waves fueled by the delta and omicron variants.