Sovateltide Improved Neurologic Outcomes for Ischemic Stroke

Results from a phase 3 clinical trial (NCT04047563) showed significant improvements in key neurologic outcomes in individuals treated with sovateltide (Tycamzzi; Pharmazz, Willowbrook, IL) for acute cerebral ischemic stroke. After 90 days, a notable number of participants treated with sovateltide showed improvements of ≥ 2 points on the modified Rankin Scale (mRS: 76.1% in the sovateltide group vs 52.8% in the control group, P=.005) and improvements of ≥ 6 points on the NIH Stroke Scale/Score (NIHSS, P=.019). These results were presented at the International Stroke Conference 2023.  

The randomized, double-blind, placebo-controlled trial enrolled 158 adult acute ischemic stroke patients who were given the standard of care and treated with either control medication (n=78) or sovateltide (n=80).  Ischemic stroke was radiologically confirmed in participants, and Alberta Stroke Program Early Computed Tomographic Score (ASPECTS) mean value was similar in the control and the sovateltide groups, indicating that the extent of infarction was similar in both groups.

Of the participants, 137 (control=70; sovateltide=67) completed the 90-day follow-up. The primary objective of the study was to determine neurologic outcome based on mRS scores, NIHSS scores, and Barthel Index (BI) scores from days 1 through 90.

“Results of this trial make us highly encouraged regarding the potential of sovateltide to be the first therapeutic since tPA to demonstrate a positive impact on patients suffering from acute ischemic stroke,” said Anil Gulati, MD, PhD, inventor, chief executive officer, and chairman of the board, Pharmazz.