Sovateltide produced statistically significant and clinically meaningful improvements in neurological outcomes in acute cerebral ischemic stroke patients and was well tolerated
Clinical trial results presented at the 14th World Stroke Congress
WILLOWBROOK, Ill., Oct. 31, 2022 (GLOBE NEWSWIRE) -- Pharmazz, Inc. (“Pharmazz”), a biopharmaceutical company focused on developing and commercializing novel therapeutics to treat patients in critical care, today 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 14th World Stroke Congress in Singapore.
“Sovateltide may be the first therapeutic since tPA to demonstrate a meaningful positive impact on patients suffering from acute ischemic stroke,” said Anil Gulati, M.D., founder, Chief Executive Officer, and Chairman of the Board of Pharmazz. “Results of this trial make us highly encouraged regarding the potential of sovateltide to be a clinically meaningful treatment for patients suffering from acute ischemic stroke. Based on these results, we have submitted our marketing authorization application to the Indian CDSCO.”
The randomized, double-blind, parallel, placebo-controlled Phase III clinical trial conducted 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 either by computed tomography (CT) scan or magnetic resonance imaging (MRI) prior to enrollment. Alberta Stroke Program Early Computed Tomographic Score (ASPECTS) mean value was similar in the control (7.44) and sovateltide (7.61) groups indicating that the extent of infarction was similar in both the groups. Patients could be enrolled if presenting up to 24 hours after onset of symptoms and with an NIHSS score greater than 5 and NIHSS level of consciousness (1A) less than 2, and a modified Rankin Scale of 3-4. 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. In addition, secondary endpoints at 90 days post-treatment include a change in the quality of life (EuroQol-EQ-5D), stroke-specific quality of life (SSQOL), the incidence of ischemic stroke recurrence, and incidence of mortality.
Primary and secondary endpoint results are shown in Table 1. At 90 days, mRS showed a statistically significantly greater number of patients with an improvement of ≥2 points on mRS, median score reduction (p=0.005) and a greater number of patients with an improvement of ≥6 points on NIHSS (p=0.0330).
Table 1. Primary and secondary endpoints results.
| Endpoints at 90 days | Control (n=70) | Sovateltide (n=67) | |
| Primary endpoints | |||
| mRS, mean (scale: 0-6) | 2.10 | 1.48 | P=0.008 |
| mRS, Change, % chg. >2 | 52.9% | 76.1% | P=0.005 |
| Patients with mRS 0-2 (%) | 55.7% | 80.6% | P=0.002 |
| NIHSS, mean (scale: 0-20) | 3.57 | 1.98 | P=0.002 |
| NIHSS, % chg. >6 pts. | 64.3% | 82.1% | P=0.019 |
| Barthel Index, mean (scale: 0-150) | 75.9 | 86.0 | P=0.011 |
| Barthel Index, % chg. ≥ 40 pts. | 61.4% | 76.1% | P=0.064 |
| Secondary endpoints | |||
| Euro QoL Scale | 80.0 | 87.0 | P=0.055 |
| Stroke Specific QoL (scale 0-6) | 3.91 | 4.17 | P=0.67 |
| Montreal Cognitive Assessment (scale: 0-40) | 22.12 | 22.64 | P=0.650 |
The improved mean mRS at 90 days was also reflected an ordinal shift of mRS scores that was favorable for sovateltide with more patients with mRS scores of 0-2 and fewer patients with scores 3-6 at 90 days than the control group (Table 2). Sovateltide demonstrated an absolute increase of 16% in patients with mRS of 0 to 3 compared to an absolute increase 9% with mRS of 0 to 3 in patients treated with tPA in stroke patients (NEJM, 333:1581-1587, 1995).
Table 2. Ordinal shift across the range of mRS at 90 days.
| % | mRS 0 | mRS 1 | mRS 2 | mRS 3 | mRS 4 | mRS 5 |
| Sovateltide n=67 | 27% | 25% | 28% | 12% | 7% | 0% |
| Control n=70 | 16% | 27% | 13% | 21% | 21% | 1% |
Sovateltide was well tolerated, with no drug-related adverse event reported. Table 3 list the most common side effects of control and sovateltide.
Table 3. Side effects of sovateltide vs. control.
| Control (n=78) | Sovateltide (n=80) | |
| Serious (all) | 2 in 2 patients | 5 in 5 patients |
| Death | 2 | 4 |
| Hyponatremia | 0 | 1 |
| Moderate (2 or more) | 22 in 16 patients | 19 in 7 patients |
| Fever | 5 | 1 |
| Hypertension | 2 | 3 |
| Cold | 2 | 0 |
| Vomiting | 1 | 2 |
| Dizziness | 0 | 2 |
| Mild (2 or more) | 9 in 6 patients | 3 in 3 patients |
| Abdominal pain | 3 | 0 |
“We plan to submit our 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 Dr. Gulati. “The change in mRS post-randomization at 90 days, which was highly statistically significant in the Indian trial, is expected to be the primary endpoint for U.S. Phase III clinical trials. This increases our optimism of the results of U.S. clinical trials. We look forward to our interactions with the U.S. FDA and the start of a pivotal clinical trial in the U.S.”
About Pharmazz, Inc.
Pharmazz, Inc. is a privately held company engaged in developing novel products in critical care medicine. Additional information may be found on the Company’s website, www.pharmazz.com.
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Shruti Gulati
Pharmazz Inc.
Email: shruti.gulati@pharmazz.com
Phone: (630) 780-6087
