Nano cap Marinus Pharmaceuticals (NASDAQ:MRNS) is up 58% premarket on robust volume in response to positive results from a Phase 2 clinical trial evaluating intravenous ganaxolone in patients with refractory status epilepticus, an emergency situation where the patient has a seizure lasting longer than five minutes or consecutive seizures that occur close together preventing recovery.
The study met the primary endpoint of the number (n=0/17) of patients requiring IV anesthetic within the first 24 hours after initiation of ganaxolone therapy. Median time to the cessation of seizure(s) was five minutes.
On the safety front, there were 10 serious adverse events, two considered treatment-related (severe sedation leading to discontinuation of therapy). There were 13 treatment-related adverse events in seven patients. The most frequent were somnolence (drowsiness), mild hypotension and sedation.
A Phase 3 trial is next up that will evaluate (assuming FDA signoff) a new ready-to-use formulation that does not require compounding, mixing or diluting.
The company will host a conference call this morning at 8:30 am ET to discuss the results.
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