Pharmazz Releases Positive Results for Trial Evaluating Sovateltide for Acute Ischemic Stroke
The findings show that at 90 days, the modified Rankin Score (mRS) had a significantly greater number of individuals with an improvement of 2 points or greater.
Pharmazz Inc released positive topline results for its phase 3 clinical trial that evaluated sovateltide as a treatment for acute ischemic stroke, according to a statement from the company.
The findings showed that, at 90 days, the modified Rankin Score (mRS) had a significantly greater number of individuals with an improvement of 2 points or greater on mRS, mRS with a significant median score reduction, and a significantly greater reduction of individuals with an improvement of 6 or more points on the NIHSS Level of Consciousness (1A) <2 (NHISS).
Sovateltide is a highly selective endothelin B receptor agonist that increases blood flow, produces neurovascular remodeling, protects neural mitochondria, and shows anti-apoptotic activity.
“We are highly encouraged regarding the potential of sovateltide to be a clinically meaningful treatment for patients suffering from acute ischemic stroke based on what we have seen of the initial data to date,” Anil Gulati, MD, founder, CEO, and chairman of Pharmazz, said in the statement. “In the meantime, we are submitting our application for marketing authorization to the Indian Central Drugs Standard Control Organization, which we expect to occur shortly, and looking forward to presenting the full study at an upcoming medical conference later in 2022.”.
Additionally, sovateltide was well tolerated, and no drug-related adverse events were reported.
The clinical trial was a double-blinded, phase 3, placebo-controlled, randomized study conducted in India. Investigators enrolled 158 individuals with acute ischemic stroke.
The individuals were in the study if they presented up to 24 hours after onset of symptoms and with a modified mRS of 3 to 4 and an NIHSS score of greater than 5.
Stroke was radiologically confirmed either by computed tomography scan or magnetic resonance imaging prior to enrollment.
The Alberta Stroke Program Early Computed Tomographic Score mean value was similar to the control, at 7.44, and sovateltide, at 7.61, groups, indicating that the extent of infarction was similar in both groups.
The primary objective was to determine the neurological outcome based on mRS score, NIHSS score, and Barthel Index scale score from day 1 through day 90 of the study.
The secondary endpoints at 90-day, post-treatment included a change in quality of life, the incidence of ischemic stroke recurrence, the incidence of mortality, and stroke-specific quality of life.
The change in mRS, post randomization, at day 90 is important and is expected to be the primary endpoint for the United States phase 2/3 clinical trials.
The findings show that the distribution of the mRS score at 90 days in the intention-to-treat population is an ordinal shift across the range that highly favors sovatelide therapy.
Additionally, the number of individuals with mRS of 0 to 2 was 23.4% higher in the sovatelide group compared with the control group.
The full data set is expected to be presented at a future medical conference.
Sovateltide is being evaluated for other acute ischemic indications.
Pharmazz Inc. announces positive results of phase III clinical trial Evaluating sovateltide as a treatment for acute cerebral ischemic stroke. Pharmazz. News release. May 25, 2022. Accessed May 25, 2022. Email.