Pharmazz Inc. Announces Completion of Enrollment of Phase 3 Clinical Trial

Pharmazz, Inc. recently announced its Phase 3 clinical trial evaluating sovateltide as a treatment for acute ischemic stroke is now fully enrolled. Sovateltide is a highly selective endothelin B receptor agonist that increases blood flow, shows anti-apoptotic activity, protects neural mitochondria, and produces neurovascular remodeling.

“Treatment of ischemic stroke has seen relatively little progress since the introduction of alteplase and similar agents in the 1990’s,” said Anil Gulati, MD, Founder, Chief Executive Officer, and Chairman of the Board of Pharmazz. “Sovateltide’s biological properties may have the potential to protect and assist in the neurovascular recovery of at-risk brain tissue following ischemic stroke. The goal of this trial is designed to test that hypothesis. We look forward to now completing patient follow-up, analyzing the data, and presenting results at a future medical conference.”

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. 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 a NIHSS (level of consciousness ) score of greater than 5. There are six primary outcomes to be evaluated, of which the change in mRS post-randomization at 90 days is the most important. It is also expected to be the primary endpoint for a US Phase 2 clinical trial. Secondary endpoints measured at enrollment and at 90 days post-treatment include a change in quality-of-life (EuroQol-EQ-5D), change in the 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.

In a Phase 2 clinical trial in ischemic stroke patients, sovateltide showed a trend of a greater number of patients with an mRS reduction of 2 or more points (15 of 17) compared to placebo (10 of 17) and a greater ratio of patients reaching an mRS of 0 (8 of 18) compare to placebo (6 or 18). A prespecified interim analysis during the Phase 3 trial (more than 30 patients per arm) showed a similar result.

Sovateltide is being evaluated in other acute ischemic indications. An Investigative New Drug (IND) application was submitted to the India Central Drugs Standard Control Organization for a Phase II 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.