Glyburide Advantage in Malignant Edema and Stroke Pilot

This is a two-center, prospective, open label, Phase IIa trial of RP-1127 (Glyburide for
Injection) in 10 patients with a severe anterior circulation ischemic stroke who are likely
to experience clinically significant brain swelling.

Subjects will receive RP-1127 (Glyburide for Injection), delivered as an IV bolus followed
by an IV infusion for 72 hours.

Subjects will have a baseline (pretreatment) MRI scan as standard of care, and three fol-low
up MRI scans (at 24+12 hours, 48+12 hours, and 72±12 hours). Since recanalization may have
an effect on outcome, the results of vascular studies, obtained as part of stan-dard of care
and defined as CTA, MRA or catheter angiography of the head and neck, will be recorded. .
Additionally, clinical endpoints such as the NIHSS, GCS and FOUR Score (baseline, 24±12
hour, 48±12 hour, 72±12 hour and 7±1 days) and mRS (30±5 days and 90±7 days) will be
assessed. Safety parameters will be assessed through Day 7 or discharge (whichever is
sooner), and then again at Day 30±5 and Day 90±7.

Study participation is expected to last 90±7 days.