Shionogi has started a global late Phase II clinical trial of redasemtide for the treatment of patients with acute ischemic stroke.
Redasemtide is a regeneration inducing medicine introduced by StemRIM, an Osaka-based drug discovery research and development-oriented biotech company.
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By GlobalDataThe initiation is based on the feedback received from regulatory agency to conduct the trial for the purpose of dose setting.
The trial will assess redasemtide’s efficacy and safety in 627 patients with acute ischemic stroke within 25 hours after onset.
Redasemtide (1.5 mg/kg), redasemtide (0.75 mg/kg) dosages will be administered to patients aged 18 years or older for five days against placebo.
Initiated in Japan, the Phase II trial demonstrated the safety and efficacy of redasemtide (1.5 mg/kg) for five days in 150 acute ischemic stroke patients.
The primary endpoint was evaluated 90 days after administration of the dose using the modified Rankin Scale (mRS) that measures the degree of dependence in the daily activities of people with stroke or other neurological conditions.
The study observed an increase in the rate of improvement to a socially independent level that does not require assistance.
It increased nearly twice as much in the redasemtide group as in the placebo group at 90 days after administration.
Shionogi is also planning to extend the trial in the US, Europe and China regions.
The optimal dose information obtained from the Phase II study will help Shionogi start a global Phase III clinical trial.
The data from the Phase III study will be used for making submissions for manufacturing and marketing approvals.
