Effects Of DP-b99 On Neurological Function In Subjects With Acute Ischemic Hemispheric Stroke

Completed

Phase 2 Results

Results

Final results in Phase IIB showed a 90-day median change in NIHSS scores of 6.0 and 5.0 points (nonsignificant) in the placebo (n=72) and treatment (n=75) groups respectively from the baseline scores of 7-20; and of 5.0 and 8.0 points in the placebo and treatment groups respectively (p=0.03) from the baseline scores of 10-16. Recovery rates for the DP-b99 and placebo groups per modified Rankin scale was 30.6% and 16.0% (p=0.05), per NIHSS was 23.6% and 12.0% (p=0.08), and by either scale was 37.5% and 18.7% (p=0.02) respectively. In Phase IIa an efficacy evaluation demonstrated significant improvements in clinical stroke outcome assessed with the NIH Stroke Scale (NIHSS) 2, 7 and 30 days after stroke in patients treated with DP-b99 within 12 hours of the onset of stroke symptoms. There were no significant differences in the number of serious adverse events, death cases or death causes between the DP-b99 and placebo groups.