Pharmazz Inc. Announces Positive Results of Phase 3 Clinical Trial Evaluating Sovateltide as a Treatment for Acute Cerebral Ischemic Stroke

Pharmazz, Inc. recently announced positive topline results of its Phase 3 clinical trial evaluating sovateltide as a treatment for acute ischemic stroke. The data at 90 days showed mRS had a significantly greater number of patients with an improvement of ≥2 points on mRS (p=0.0045), mRS with a significant median score reduction (p=0.0078) and a significantly greater number of patients with an improvement of ≥6 points on NIHSS (p=0.0330). In addition, sovateltide was well tolerated, with no drug-related adverse event reported. The results have prompted Pharmazz to apply for marketing authorization from the Indian Central Drugs Standard Control Organization (CDSCO). In addition, the full data set is expected to be presented at a future medical conference. Sovateltide is a highly selective endothelin B receptor agonist that increases blood flow, shows anti-apoptotic activity, protects neural mitochondria, and produces neurovascular remodeling.

“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,” said Anil Gulati, MD, founder, Chief Executive Officer, and Chairman of the Board of Pharmazz. “In the meantime, we are submitting our application for marketing authorization to the Indian CDSCO, which we expect to occur shortly, and looking forward to presenting the full study at an upcoming medical conference later in 2022.”

The randomized, double-blind, parallel, placebo-controlled Phase 3 clinical trial conducted in India enrolled 158 adult acute ischemic stroke patients who were provided the standard of care and treated with either vehicle or sovateltide. 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 a modified Rankin Score (mRS) of 3 to 4 and an NIHSS (NIHSS Level of Consciousness (1A) <2) score of greater than 5. 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. More information, including additional primary and secondary outcome measures, can be found at NCT04047563.

The change in mRS post-randomization at 90 days is the most important and is expected to be the primary endpoint for US Phase 2/3 clinical trials. Results show that the distribution of the mRS score at 90 days in the intention-to-treat population an ordinal shift across the range that highly favors sovateltide therapy. In addition, the number of patients with mRS of 0 to 2 was 23.4% higher in the sovateltide compared to the control group (p=0.0036). Treatment with sovateltide was well tolerated, and results on the other endpoints will be presented at an upcoming medical conference.

Sovateltide is being evaluated in other acute ischemic indications. In addition, the company recently applied for an Investigational New Drug application from CDSCO for a multicenter, randomized, placebo-controlled Phase 2 clinical trial in hypoxic-ischemic encephalopathy in neonates.

Pharmazz, Inc. is a privately held company engaged in developing novel products in critical care medicine. For more information, visit www.pharmazz.com.