Sovateltide produced statistically significant and clinically meaningful improvements in neurological outcomes in acute cerebral ischemic stroke patients and was well tolerated
The efficacy of sovateltide was similar in patients who received or did not receive thrombolytics
WILLOWBROOK, IL, USA I February 10, 2023 I Pharmazz, Inc. (“Pharmazz”), a biopharmaceutical company focused on developing and commercializing novel therapeutics to treat patients in critical care, presented positive results of its Phase III clinical trial evaluating sovateltide as a treatment for acute ischemic stroke. Sovateltide demonstrated statistically significant and clinically meaningful improvements in multiple neurological outcomes in patients with acute cerebral ischemic stroke and was well tolerated. The trial results were presented in an oral session at the American Stroke Association, International Stroke Conference 2023, on February 9, 2023, in Dallas. The presentation is titled “A Multicentric, Randomized, Controlled Phase III Study With Sovateltide (Tycamzzi™) Improving Outcomes In Patients With Acute Cerebral Ischemic Stroke.”
Sovateltide is being evaluated as a potential medication to treat cerebral ischemic stroke patients. “We have submitted an Investigational New Drug (IND) application to conduct a Phase III clinical trial in acute ischemic stroke to the U.S. Food and Drug Administration (FDA),” said Gulati, M.D., Ph.D. Chairman and Chief Executive Officer at Pharmazz, Inc. “We look forward to our interactions with the U.S. FDA and the start of a pivotal clinical trial in the United States and the European Union.”
Sovateltide produced significant and clinically meaningful improvements in neurological outcome in stroke patients
The randomized, double-blind, parallel, placebo-controlled Phase III clinical trial conducted across 18 centers in India enrolled 158 adult acute ischemic stroke patients who were provided the standard of care and treated with either vehicle (n=78) or sovateltide (n=80). One-hundred-thirty-seven (control=70, sovateltide=67) completed the 90-day follow-up. Ischemic stroke was radiologically confirmed, and Alberta Stroke Program Early Computed Tomographic Score (ASPECTS) mean value was similar in the control and sovateltide groups, indicating that the extent of infarction was similar in both the groups. Patients were included if presenting up to 24 hours after the onset of stroke symptoms, with an NIHSS score greater than 5, NIHSS level of consciousness (1A) less than 2, and a modified Rankin Scale of 3-4. Co-morbidity of diabetes, hypertension and combined diabetes and hypertension were similar in the control and sovateltide groups. However, 25.6% of patients in the control group, whereas only 11.2% of patients in the sovateltide group, received thrombolytics. The primary objective was to determine the neurological outcome based on mRS score, NIHSS score, and BI scale score from day 1 through day 90. At 90 days, mRS showed a statistically significantly greater number of patients (52.8% in control and 76.1% in sovateltide groups) with an improvement of ≥2 points on mRS, mean score reduction (p=0.005) and a greater number of patients (64.3% in control and 82.1% in sovateltide groups) with an improvement of ≥6 points on NIHSS (p=0.019). In addition, a numerically greater number of patients (61.4% in control and 76.1% in sovateltide groups) showed an improvement of ≥40 points on BI (p=0.064). Sovateltide was well tolerated, with no drug-related adverse event reported.
The improved mean mRS at 90 days also reflected an ordinal shift of mRS scores favorable for sovateltide (Table 1).
Table 1. The ordinal shift across the range of mRS at 90 days.
| Group | mRS 0 | mRS 1 | mRS 2 | mRS 3 | mRS 4 | mRS 5 | mRS 6 |
| Sovateltide n=71 | 25 % | 24 % | 27 % | 11 % | 7 % | 0 % | 6 % |
| Control n=72 | 15 % | 26 % | 13 % | 21 % | 21 % | 1 % | 3 % |
Further analysis excluding patients who received thrombolytics indicated that sovateltide produced statistically significant and clinically meaningful improvements in neurological outcomes in patients who received or did not receive thrombolytics (Table 2).
Table 2. Endpoint results in all patients including those treated with thrombolytics and excluding those treated with thrombolytics. P value compares control vs sovateltide at 90 day.
| Endpoints at 90 days compared to baseline |
Difference between the means in all patients including with thrombolytics |
Difference between the means in patients excluding thrombolytics |
|
mRS (scale: 0-6) |
-0.62 ± 0.23 (95% CI -1.07 to -0.17) (P=0.007) |
-0.69 ± 0.24 (95% CI -1.18 to -0.21) (P=0.005) |
|
NIHSS (scale: 0-42) |
-1.58 ± 0.51 (95% CI -2.60 to -0.57) (P=0.002) |
-1.98 ± 0.56 (95% CI -3.08 to -0.87) (P=0.001) |
|
Barthel Index (scale: 0-100) |
10.19 ± 3.95 (95% CI 2.37 to 18.00) (P=0.011) |
10.07 ± 4.21 (95% CI 1.71 to 18.42) (P=0.012) |
“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, M.D., Ph.D., Inventor, Chief Executive Officer, and Chairman of the Board of Pharmazz.
About Pharmazz, Inc.
Pharmazz, Inc. is a privately held company developing novel products in critical care medicine. Additional information may be found on the Company’s website, www.pharmazz.com.
Media contacts:
Shruti Gulati Pharmazz Inc.
Email: shruti.gulati@pharmazz.com
Phone: (630) 780-6087
SOURCE: Pharmazz
