LUMOSA Therapeutics announced TFDA's clearance of Phase 2 IND application for multiple-dose of LT3001 in patients with acute ischemic stroke. Accumulated investment expenditure incurred: The accumulated development cost is related to future licensing negotiation. Relevant information is not disclosed at this time to avoid unwanted impact on the licensing deal and to protect the equity of the shareholders.

Estimated date of completion: The Phase 2 study is expected to be completed within 2 years. The actual timeline depends on recruitment progress. Brain stroke is one of several diseases that the medical community is trying urgently to resolve.

Each year, there are about 15 to 17 million people in the world suffering stroke; among which, 80% of the patients are ischemic. The current treatment for acute ischemic stroke (AIS) is a thrombolytic agent named rt-PA. Unfortunately, the benefit of rt-PA is limited due to its high risks involving hemorrhage and short treatment time window, only 3%~5% AIS patients are treated with thrombolytics.

Other than thrombolytic agent, mechanical thrombectomy is another treatment options but with limited clinical efficacy. Should LT3001 be presented with a desirable safety profile, the drug can be applied either alone or in combination with thrombectomy to the stroke patients within 24hr stroke onset, and the potential market size could reach $10.6 billion.