TAIPEI (Taiwan News) — Taiwan's Lumosa Therapeutics Co. announced Thursday that it has received written guidance from the US Food and Drug Administration regarding its investigational drug for acute ischemic stroke.
Stroke is a leading cause of death and disability worldwide. Ischemic stroke occurs when reduced blood flow deprives brain tissue of oxygen and nutrients, causing neurological deficits or death, according to China Medical University Head of Faculty Shen Wu-chung (沈戊忠).
Treatment options have remained limited, with no major breakthroughs in nearly two decades, highlighting a significant unmet medical need, according to Gene Online.
Lumosa’s LT3001 is an innovative small-molecule drug that works in two ways: it helps dissolve blood clots and protects brain cells. The drug aims to extend the treatment window from the current 4.5 hours to 24 hours, potentially allowing more patients to receive timely intervention.
The FDA guidance follows Lumosa’s earlier Type C consultation, which focused on preclinical data completeness, Phase III trial design, including efficacy endpoints, sample size, patient eligibility, and interim analyses, and other requirements for potential US regulatory approval. The company said the FDA’s recommendations will be used to finalize the Phase III clinical trial protocol, according to CTEE.
Preclinical animal studies and early clinical trials suggest that LT3001 can improve neurological outcomes in ischemic stroke patients without increasing bleeding risk, which effectively extends the treatment window. The drug received FDA Fast Track designation in January 2022, which could accelerate the review process and potential approval.
Following the announcement, Lumosa shares opened Friday at NT$215 (US$7), up 8.59%, surpassing both six-month and one-year moving averages.
