New Chinese Drug May Extend Stroke Treatment Window to 48 Hours, Study Finds
Chinese researchers have reported promising results from a new experimental drug that could significantly extend the treatment window for certain patients suffering from acute ischemic stroke.
The drug, known as loberamisal, was tested in a large Phase 3 clinical trial involving nearly 1,000 patients at 32 hospitals across China. Researchers found that patients who received the drug within 48 hours of stroke symptoms were more likely to achieve a strong level of functional recovery after 90 days compared with patients who received a placebo.
What is loberamisal?
Loberamisal is an experimental neuroprotective medicine designed to protect brain cells following an ischemic stroke. Unlike treatments primarily aimed at removing a blood clot, the drug targets biological pathways involved in brain-cell injury.
The researchers describe loberamisal as a small-molecule compound that acts on two targets, including the PSD-95 pathway and the alpha-2 GABA-A receptor. The aim is to reduce damage to brain tissue and support neurological recovery after a stroke.
Study tested treatment within 48 hours
The LAIS randomized clinical trial included 998 adults with acute ischemic stroke. Participants were between 18 and 80 years old and had no significant disability before their stroke.
Patients were randomly assigned to receive either intravenous loberamisal or a placebo alongside standard stroke care. The treatment was administered once daily for 10 consecutive days.
The study focused on whether patients could achieve a modified Rankin Scale score of 0 or 1 after 90 days, which represents little or no disability.
Promising recovery results
According to the results published in JAMA, 69.7% of patients receiving loberamisal achieved the study's definition of full functional outcome at 90 days, compared with 56.3% of those receiving placebo.
That represents a difference of about 13 percentage points between the two groups.
Researchers also reported that serious adverse events occurred in 8.6% of patients in the loberamisal group and 10.7% in the placebo group. Death from any cause occurred in 1.2% and 2.0% of patients, respectively.
Why the 48-hour window matters
Stroke treatment is highly time-sensitive because brain tissue can be damaged when blood flow is interrupted. Some established emergency treatments for ischemic stroke have relatively narrow treatment windows, although eligibility can vary depending on the patient's condition and brain imaging.
A longer window for a neuroprotective treatment could potentially provide an additional option for patients who arrive at a hospital after the earliest treatment period.
However, the new findings do not mean that stroke patients should wait 48 hours before seeking emergency treatment. Stroke symptoms require immediate medical attention because currently available emergency interventions may need to be delivered as quickly as possible.
Researchers say more evidence is needed
Although the Phase 3 findings are encouraging, the researchers noted that further studies are required to confirm the results and determine whether the benefits apply to a broader range of stroke patients.
The trial included a specific group of patients with acute ischemic stroke, meaning the findings should not automatically be applied to every type of stroke or every patient.
Researchers will also need to determine how the drug performs in different patient populations and alongside other modern stroke treatments.
Potential impact on stroke care
If the findings are confirmed in additional research and the treatment receives appropriate regulatory approval, loberamisal could become an important area of research in stroke medicine.
The possibility of protecting brain tissue after the initial hours following a stroke could be particularly significant for patients who reach medical care later than expected.
For now, however, the study represents a promising research development rather than a replacement for established emergency stroke treatment.
Source
Source: JAMA, LAIS Randomized Clinical Trial, PubMed and American Heart Association.
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