Lumosa Therapeutics has announced positive results from its Phase II clinical trial of LT3001 in patients with acute ischemic stroke. The study, conducted by Lumosa's licensing partner, Shanghai Pharma in China, evaluated the safety and efficacy of LT3001 and provides crucial data for further clinical development of the drug.
The Phase II trial was a multi-center, randomized, double-blind, placebo-controlled, parallel-design study that enrolled 300 subjects with acute ischemic stroke. The primary objective was to assess the safety profile of LT3001 across multiple doses, focusing on adverse events within 90 days of administration and the incidence of intracranial hemorrhage within three days of the first dose. The secondary objective was to evaluate improvements in daily activities at 90 days post-treatment, measured by the proportion of patients achieving a 0-1 score on the modified Rankin Scale (mRS).
Safety and Tolerability
The trial results indicated that LT3001 demonstrated robust overall safety and tolerability. Adverse event rates within 90 days of the first dose were comparable across the high-dose, low-dose LT3001, and placebo groups. The majority of adverse events were mild to moderate in severity. Notably, no symptomatic intracranial hemorrhages were observed in any of the groups. Only three asymptomatic intracranial hemorrhages were reported, all of which occurred in the placebo group.
Preliminary Efficacy
In terms of efficacy, LT3001 showed preliminary signs of effectiveness, with a promising proportion of subjects achieving 0-1 mRS scores at Day 90 post-treatment. The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability.
Future Development
Lumosa Therapeutics plans to continue its collaboration with Shanghai Pharma and actively pursue licensing negotiations with international pharmaceutical companies. The company aims to accelerate the global development plan for LT3001 to deliver more innovative and effective treatment options for stroke patients. These trial results provide critical data to support the further development of LT3001 in the acute ischemic stroke domain.
