Lumosa Therapeutics

Acute ischemic stroke

1/4

1 In 4 people over 25 will have a stroke in life
13.7M

There are over 13.7 million new strokes each year
tPA

tPA is the only US FDA approved medication for acute ischemic stroke
3-5%

Only 3~5% stroke patients receive tPA

According to the WHO, stroke is the second leading cause of death with approximately 6 million deaths in the world per year. Stroke can be categorized as a hemorrhagic or an ischemic stroke. Studies show ischemic stroke, which LT3001 intends to treat, occurs in about 85% of all stroke cases.
The only FDA approved treatment for ischemic strokes is tissue plasminogen activator (tPA, also known as IV tPA). tPA works by dissolving the clot but only for those patients presenting within 3 or 4.5 hours of ischemic stroke onset due to increased risk for intracranial hemorrhage in stroke patients with extended time window. Due to its limited applied condition and safety concerns, the actual usage of tPA in a clinical setting is only 3%~5%. A new safer and more effective treatment for ischemic stroke without brain hemorrhage has been long overdue.

How LT3001 could help?

The fear of brain hemorrhage associated with thrombolytic agents has hindered the development of stroke new drugs. LT3001, a novel molecule, has demonstrated recanalization capabilities without the increased risk of hemorrhagic transformation. Through enhancing the binding of plasminogen to the fibrin, LT3001 safely restores blood vessel patency by promoting the local endogenous fibrinolysis activity, meanwhile limiting oxidative stress and protect tissues from reperfusion injury. The molecule not only holds promise as a superior and safer therapy to expand the treatable population and improved the outcome after stroke, but also become a universal treatment for other thrombus-related diseases.

1

Blood clot formation
The obstructive blood clots are resulted from series of failures in endogenous fibrinolysis that became the pathological basis of ischemic stroke. Blood clots are composed of red blood cells, white blood cells, and platelets, bound together by cross-linked fibrin. The plasminogen would bind to fibrin which activates plasmin, the primary effector protein dissolving the blood clots. However, when endogenous fibrinolysis fails to dissolve the clot, the resulting ischemia causes cell injury, free radicals-mediated oxidative stress, and inflammation, leading to organ damage.
2

The action of LT3001 at thrombosis site
LT3001 safely restores blood vessel patency by promoting the local endogenous fibrinolysis activity. LT3001 enhances the binding of plasminogen to the fibrin clot and facilitates the activation of plasminogen to plasmin while simultaneously protecting the tissues from free radicals and inflammation-mediated injury.

Development progress

LT3001 has successfully completed 2 Phase 2b clinical trials across the U.S., EU, China, and Taiwan, demonstrating strong efficacy and a favorable safety profile with no hemorrhagic complications, while offering an extended therapeutic window of up to 24 hours post-stroke onset. Lumosa is preparing a two-prong development strategy for LT3001 - in the US and China, Phase 3 trials will be conducted in the AIS patients left with no treatment options to expand the potential treatable population. The development and commercial rights in China have been granted to Shanghai Pharmaceuticals.

Clinical Trials

Stage
Description
Region
Status
Link

Stage :
Phase 1 (LT3001-101)
Description :
Single dose on healthy volunteers
Region :
USA
Status :
Completed
Link :
TBA

Stage :
Phase 1 (LT3001-103)
Description :
Multiple dose on healthy volunteers
Region :
China
Status :
Completed
Link :

Stage :
Phase 1 (LT3001-105)
Description :
Multiple dose on healthy volunteers
Region :
USA
Status :
Completed
Link :

Stage :
Phase 2a (LT3001-201)
Description :
Single dose on AIS patients
(within 24 hrs)
Region :
USA/Taiwan
Status :
Completed
Link :

Stage :
Phase 2 (LT3001-202)
Description :
Multiple dose on AIS patient
(within 24 hrs)
Region :
China
Status :
Completed
Link :

Stage :
Phase 2 (LT3001-203)
Description :
Multiple dose with thrombectomy on AIS patient
(within 24 hrs)
Region :
USA/Taiwan
Status :
Ongoing
Link :

Stage :
Phase 2 (LT3001-205)
Description :
Multiple dose on AIS patient
(within 24 hrs)
Region :
USA/Taiwan/EU
Status :
Completed
Link :

LT3001-Related Studies

Jiang, Y., Ji, Y., Zhou, I. Y., et al. (2024). Effects of the new thrombolytic compound LT3001 on acute brain tissue damage after focal embolic stroke in rats. Translational Stroke Research, 15, 30–40. https://doi.org/10.1007/s12975-022-01107-3

Chao, A. C., Lee, T. H., Pettigrew, L. C., Hannawi, Y., Huang, H. Y., Chi, N. F., Chan, L., Chen, P. L., & Devlin, T. (2024). Intravenous odatroltide for acute ischemic stroke within 24 hours of onset: A phase 2, multicenter, randomized, double-blind, placebo-controlled study. Drug Design, Development and Therapy, 18, 2033–2042. https://doi.org/10.2147/DDDT.S460831

Pipeline

LT3001

Acute ischemic stroke

Blood clot formation

The action of LT3001 at thrombosis site

Development progress

Clinical Trials

LT3001-Related Studies

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