A Study to Assess the Safety and Efficacy of Sovateltide in Patients With Acute Cerebral Ischemic Stroke
Status:
Not yet recruiting
Trial end date:
2025-06-01
Target enrollment:
Participant gender:
Summary
Extensive research is being conducted in search of neuroprotective agents for possible use in
the acute phase of stroke and agents that can be used for neurorepair in later stages of
stroke. Several trials have been conducted and are in progress using different
pharmacological agents, but none of the studies involve the stimulation of ETB receptors to
treat cerebral ischemic stroke. Sovateltide (IRL-1620, PMZ-1620) has been effective in animal
models of cerebral ischemic stroke. Its safety and tolerability have been demonstrated in a
human phase I study with 7 subjects. Clinical phase II and III results indicate that
sovateltide is a novel, first-in-class, highly effective drug candidate for treating cerebral
ischemic stroke. Safety and significant efficacy in improving the National Institutes of
Health Stroke Scale (NIHSS), Modified Rankin scale (mRS), and Barthel index (BI) obtained in
phase II and III studies in patients with cerebral ischemic stroke in India are convincing
and encouraged us to investigate its safety and efficacy in cerebral ischemic stroke patients
in the United States. Therefore, we now plan to conduct a phase III clinical study to
evaluate the safety and efficacy of sovateltide therapy along with standard of care in
patients of acute ischemic stroke.