Marinus Pharmaceuticals Inc (NASDAQ:MRNS) continues its clinical programs with little or no impact because of ongoing coronavirus crises. The company expects to report topline data from Phase 3 clinical study to treat CDKL5 deficiency disorder (CDD) in Q3 2020. It is preparing to submit an NDA application and commercialize ganaxolone.
Receives FDA nod for RPDD for Ganaxolone
Marinus ganaxolone received a rare pediatric designation from the Food and Drug Administration (FDA) in CDD. It is an important achievement for patients and Marinus as well. CEO off Marinus, Scott Braunstein, said the company is preparing for the next phase of growth. He further said the company is executing multiple clinical trials and developing innovative formulations to provide investors with long-term growth.
On track to enroll for Phase 3 clinical trials
Marinus is on track to recruit patients for Phase 3 clinical study in Q3 2020. The company already preselected 50 of the 100 sites in the US for trial. It is a randomized and placebo-controlled clinical trial, which will be conducted in SE patients, who failed in second-line intravenous AEDS (anti-epileptic drugs) or benzodiazepines.
Marinus will enroll 125 patients to receive a placebo or ganaxolone adjunct to the standard care. It will identify the efficacy of ganaxolone compared to the placebo. The company expects topline data from this clinical study in H1 2022.
Adds Chuck Austin to the board
Marinus recruited Chuck Austin to the board of directors to strengthen its clinical trials and new product development. The company will also add new leadership to augment legal, clinical development, commercialization, and R&D.
Commenting on the addition to the board, Scott said Chuck is a pioneer in the medical device and pharmaceutical industries. Marinus will use his expertise in biopharma and manufacturing to drive growth going forward. Previous stints of Scott include 25 years of solid experience in life sciences. He held several roles in engineering, R&D, and supply chain operations at Johnson & Johnson.
Marinus posted a loss of $15.7 million in Q2 2020. Its expenses surged to $30 million in Q2 2020. The company has cash, including investments of $105.99 million as of June 30, 2020, to manage Capex and operational expenses for up to 2022.