A phase 2 proof-of-concept study will begin in the US later this year for LT3001 (Lumosa Therapeutics, Taipei, Taiwan), a novel therapy for treating acute ischemic stroke (AIS). Enrollment of participants for the phase 2 study in Taiwan will begin in 2020. Full enrollment is expected to take 2 years to complete; time to completion will depend upon outcomes observed.
In animal studies, LT3001 restored cerebral blood flow and reduced ischemic/reperfusion injury. In phase 1 single-dose escalation studies, LT3001 was well tolerated with no adverse effects in16 healthy people. Those individuals were dosed intravenously with a low dose of LT3001 and achieved blood concentrations higher than the effective dose in animal studies. Mild headache that resolved quickly was seen in 1 participant when give the high dose of LT3001 in one subject in the high-dose group.
Rong-Chin Lin, president and CEO, Lumosa Therapeutics, said “Drugs that treat AIS have reached bottlenecks as they've failed to address both the safety issue and efficacy at the same time. LT3001's progression into phase 2 clinical trial is a significant milestone in Taiwan's new drug development history. Judging from the results of the completed studies, LT3001 has the great potential to overcome the above-mentioned obstacles. Lumosa will actively seek codevelopment partners for LT3001 in the world to share development risks, and soon materialize LT3001's intellectual value.”