MICOT PHARMA-B (ASX: 02335) has announced that the first patient has been successfully dosed in the Ib/II phase clinical trial for its self-developed investigational drug, MT1002, intended for the treatment of acute ischemic stroke (AIS). This milestone signifies the official entry of this pivotal registration study into its substantive execution phase.
This Ib/II phase clinical trial is divided into two parts. The first part is a multicenter clinical study evaluating the safety, efficacy, and pharmacokinetic profile of MT1002 in patients with acute ischemic stroke. The second part is a multicenter, randomized, standard-of-care controlled clinical study designed to assess the safety and efficacy of MT1002 in patients with acute ischemic stroke. The first patient dosing announced refers specifically to the first patient in the first part of this Ib/II phase trial.
Acute ischemic stroke is a clinical syndrome characterized by the sudden, severe narrowing or occlusion of a cerebral artery due to various causes, leading to local brain tissue ischemia, hypoxic necrosis, and corresponding neurological deficits, with new cerebral infarction changes visible on head CT or MRI. It is the most common type of stroke. A 2025 review on treatment advances for acute ischemic stroke reported that AIS accounts for 69.6% to 72.8% of new stroke cases in China.
According to data from industry sources, the market size for major acute-phase therapeutic drugs for ischemic stroke in China has consistently exceeded 10 billion yuan in recent years, reaching 12.9 billion yuan in 2023.
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