Marinus Sinks To 2-Year Low As Postpartum Depression Drug Found Ineffective At 28 Days

Marinus Pharmaceuticals Inc MRNS shares were losing more than half their value and slumping to a two-year low Tuesday. 

What Happened

Marinus — a pharma company that focuses on developing therapies for epilepsy, depression and other neuropsychiatric disorders — announced results from the second part of a Phase 2 Magnolia clinical trial that evaluated intravenous ganaxolone in women with postpartum depression, or PPD.

The results showed that the Hamilton Rating Scale for Depression, or HAM-D17, scores at 28 days of treatment were the same as a placebo.

Yet IV ganaxolone administered as a six-hour infusion followed by oral administration provided meaningful reductions in HAM-D17 scores at the early time points of six hours and 24 hours after the start of the treatment. It was also found to be safe and well-tolerated, Marinus said. 

"Taken together, Parts 1 and 2 of the Magnolia Study show that IV ganaxolone has the potential to provide rapid, safe and meaningful clinical improvements for mothers struggling with PPD," Bassem Maximos, a principal Investigator of the study, said in a statement. 

Marinus also released data from the Phase 2 Amaryllis study that showed that oral ganaxolone alone was generally well-tolerated and safe, with signs of a rapid onset of clinical activity in the high dose cohort.

Why It's Important

PPD affects about 15% of women within the first year following childbirth.

SAGE Therapeutics Inc SAGE recently received FDA approval for its PPD drug Zulresso in an injectable formulation.

What's Next

Marinus said it plans to meet with regulators to discuss the development pathway for IV ganaxolone in PPD.

The company also said it will continue to explore the development of the candidate in other severe depressive disorders while also advancing its programs in orphan epilepsies and refractory status epilepticus.

Marinus said it is planning to present the full set of data from these studies for publication or presentation at a future medical conference.

The stock was falling by 66.21% to $1.34 at the time of publication Tuesday. 

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