Lumosa Therapeutics Announces US FDA Clearance of IND Application for a Phase 2 Multi-Dose Study of LT3001 in Patients with Acute Ischemic Stroke. The accumulated development cost is related to future licensing negotiation. In order not to affect the amount of licensing fee and to protect the equity of the shareholders, the information related are not disclosed currently.

The Phase 2 multi-dose, multi-national, multi-site study is expected to be completed within 2 years. The trial will enroll 200 patients with acute ischemic stroke within 24 hours of stroke symptom. The actual timeline depends on recruitment progress.

Lumosa has received the acceptance of Phase 2 multi-dose clinical trial from the US FDA for LT3001 in patients with acute ischemic stroke. 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 approximately 3% to 5% of AIS patients are treated with thrombolytics. Mechanical thrombectomy is another treatment option that can be considered besides thrombolytic agent but it has limited clinical efficacy.

With its desirable safety profile, LT3001 may reach a market size of USD 10.6 billion if the drug can be applied either alone or in combination with thrombectomy to stroke patients within the 24-hour stroke onset. According to the collaboration agreement between The Company and the inventors of LT3001, the company will pay 5% of the license income if the technology is licensed to a third part and 2% of the net sales revenue if the product is marketed. New drug development requires long process, vast investments and with no guarantee in success which may pose investment risks.