Marinus Pharmaceuticals Inc. shares fell 7.5% to $11.14 after the pharmaceutical company reported data from a Phase 2 study.
The company Tuesday reported data from its Phase 2 trial evaluating adjunctive oral ganaxolone treatment in 23 patients with seizures associated with tuberous sclerosis complex.
The data showed a median 16.6% reduction in 28-day primary endpoint seizure frequency relative to the four-week baseline period, with 30.4% of patients achieving a 50% or more seizure reduction.
Truist Securities said interim data showing 47.6% median seizure reduction was highly encouraging, but "final Ph2 data showing 16.6% median seizure reduction...while within margin of error, may nonetheless be viewed as a bit disappointing."
Marinus said it also had meaningful 50% responder rates in subgroups of highly refractory seizure patients on concomitant medications cannabidiol or everolimus.
Truist in its analyst note said that despite a high bar, ganaxolone led to further seizure reductions on top of standard of care drugs cannabidiol and everolimus.
"Given the efficacy of the recently approve anti-epileptics cannabidiol and everolimus, we think further seizure reduction of GNX as add-on is highly impressive," Truist said in its note.
Due to drug-drug interaction of cannabidiol and everolimus "we think GNX is particularly well-poised to be the preferred add-on to EVE, which is widely used to treat several non-seizure manifestations of TSC," the analyst note said.
Marinus said it expects a Phase 3 trial of adjunctive ganaxolone in about 160 TSC patients to begin enrollment during the fourth quarter.
"We think GNX has clear efficacy signal in TSC. But the hurdle will be in proper pivotal trial design and execution," Truist said.
No comments:
Post a Comment
Note: Only a member of this blog may post a comment.