11/15/2024
We are thrilled to share the results of our Phase III clinical trial carried out in India in peer reviewed manuscript titled " Efficacy and Safety of Sovateltide in Patients with Acute Cerebral Ischaemic Stroke: A Randomised, Double‑Blind, Placebo‑Controlled, Multicentre, Phase III Clinical Trial" has been published in "Drugs"
In this research the authors explored the efficacy and safety of sovateltide in adult participants with acute cerebral ischemic stroke.This was a randomised, double-blind, placebo-controlled, multicentre, Phase III clinical trial of sovateltide in participants with cerebral ischemic stroke receiving standard of care (SOC) in India. Patients aged 18–78 years presenting up to 24 h after the onset of symptoms with radiologic confirmation of ischemic stroke and a National Institutes of Health Stroke Scale score (NIHSS) of ≥ 6 were enrolled.
The paper concluded that the sovateltide group had a greater number of cerebral ischemic stroke patients with lower mRS and NIHSS scores at 90 days post-treatment than the control group. This trial supported the regulatory approval of sovateltide in India, but a multinational RESPECT-ETB trial will be conducted for US approval.
You can read the full paper here: https://rdcu.be/d0gzO