Pharmazz is on its way to India’s drug regulator for the second time as its investigational treatment passed muster in a Phase III study in patients with acute ischemic stroke.
The Chicago suburbs-based biotech said its drug sovateltide led to better improvement than placebo on certain measurements of neurological outcomes.
Sovateltide led an improvement of ≥2 points on mRS and an increase of ≥6 points on NIHSS at day 90 in the trial of 158 adults in India. The modified Rankin scale looks at the degree of dependence in the daily activities of people post-stroke event, and the NIH stroke scale measures the stroke-related neurologic deficit.
Pharmazz expects to submit the drug for approval in India “shortly.” The 12-year-old biotech said the drug, licensed from Midwestern University in Downers Grove, IL, was well tolerated and had no drug-related adverse events. Pharmazz is also testing the drug in patients with Alzheimer’s.