Lumosa Therapeutics, the new drug development subsidiary of Center Laboratories, announced on the 29th that its flagship ischemic stroke drug, LT3001, demonstrated promising efficacy in its Phase II clinical trial in China. In addition to meeting safety benchmarks, the trial results revealed that a higher proportion of patients treated with LT3001 within 24 hours of stroke onset regained near-normal pre-stroke functionality (mRS = 0–1). The degree of improvement surpassed traditional thrombolytic therapies, confirming LT3001's potential efficacy and achieving proof-of-concept validation.

Traditional thrombolytic drugs, such as rt-PA, are limited to use within 4.5 hours post-stroke due to bleeding risks, significantly restricting the treatment window. However, the data indicates that LT3001 has the potential to improve neurological outcomes for patients treated within 24 hours of stroke onset, without increasing bleeding risks. This breakthrough could extend the critical treatment window from 4.5 hours to 24 hours, potentially redefining stroke treatment paradigms.

According to an announcement by Lumosa's Chinese licensing partner, Shanghai Pharmaceuticals, the Phase II trial in China was successfully conducted under its leadership. The trial evaluated the safety and efficacy of LT3001 in acute ischemic stroke patients, providing critical data to support further clinical development.

This multi-center, randomized, double-blind, placebo-controlled Phase II trial enrolled 300 acute ischemic stroke patients in China.

• Primary Objective: To assess the safety of multiple doses of LT3001, including the incidence of adverse events and adverse reactions within 90 days of the first dose. This included the incidence of symptomatic and asymptomatic intracranial hemorrhage within three days post-treatment.
• Secondary Objective: To evaluate improvements in daily functional outcomes at 90 days, measured by the proportion of patients achieving mRS scores of 0–1.

The results confirmed that LT3001 injection demonstrated good overall safety and tolerability. The incidence of adverse events and reactions within 90 days was comparable across the high-dose LT3001, low-dose LT3001, and placebo groups, with the majority being mild to moderate. Importantly, no symptomatic intracranial hemorrhages were reported in any group. Of the three cases of asymptomatic intracranial hemorrhage, all occurred in the placebo group.

On the efficacy front, LT3001 injection showed preliminary effectiveness, with a higher proportion of patients achieving mRS scores of 0–1 by day 90.

Lumosa Therapeutics stated that the trial results provide critical data to support the continued development of LT3001 in the acute ischemic stroke field. The company will maintain close collaboration with its partner Shanghai Pharmaceuticals and actively pursue licensing discussions with international pharmaceutical companies to accelerate global development plans. Lumosa remains committed to offering innovative and effective treatment options for stroke patients worldwide.

Resource: 順藥中風新藥LT3001大陸二期試驗結果 證實具療效潛力