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2025.03.10

Lumosa Ends Phase 2 Trial Early to Facilitate EOP2 Meeting for LT3001 with US FDA

Lumosa announced today (2025/3/10) that it is concluding its Phase 2 clinical trial for LT3001, a new treatment for acute ischemic stroke, ahead of schedule. The Company will integrate data from the Phase 2 trial conducted by Shanghai Pharmaceuticals in China  and apply to the US FDA for an end-of-phase 2 sonsultation meeting to accelerate the US Phase 3 clinical trial.

LT3001 is a novel treatment combining thrombolysis and neuroprotection that has received clinical trial approval from the US, Europe, China and Taiwan. When compared to existing therapeutics where only 3~5% of the patients suffering from acute ischemic stroke receive treatment, LT3001's 24-hour treatment window has the potential to significant expand the applicable patient population. 

Approximately 15 million people suffer ischemic stroke annually worldwide, and existing treatments are associated with risks of hemorrhage and limited treatment windows. If successfully launched, LT3001 will fill a significant medical gap, tapping into a potential market of up to US$10.6 billion, generating significant commercial value for the Company and strengthening its leadership in neurological diseases.