Marinus Pharmaceuticals provided a corporate update for investors, including its roadmap for advancing ganaxolone in 2020.
Marinus Pharmaceuticals (NASDAQ:MRNS) provided a corporate update for investors, including its roadmap for advancing ganaxolone in 2020.
As quoted in the press release:
Key 2020 Milestones:
- Initiate Phase 2 clinical trial in patients with Tuberous Sclerosis Complex (TSC) – 1H 2020
- Initiate U.S. pivotal Phase 3 clinical trial in patients with Status Epilepticus (SE) – mid-2020
- Report top-line data from global, pivotal Phase 3 clinical trial in children with CDKL5 Deficiency Disorder (CDD) – Q3 2020
“Our 2019 clinical progress, along with the bolstering of our executive leadership and balance sheet, now positions us to begin to unlock the value of our ganaxolone franchise,” said Scott Braunstein, M.D., Chief Executive Officer of Marinus. “Our strategy is focused on mechanistically relevant disease states for ganaxolone that have the potential to significantly improve outcomes for patients. With our Phase 3 study reading out in CDKL5 deficiency disorder later this year, we are making preparations for our first NDA filing and commercial launch with oral ganaxolone. In addition, we are advancing our hospital-directed intravenous dose form into a Phase 3, potentially NDA enabling, study in status epilepticus later this year.”