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LT3001

Acute ischemic stroke

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 cases4.
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 1%~8%. A new safer and more effective treatment for ischemic stroke without brain hemorrhage has been long overdue.

1. World Stroke Organization. (2022). Learn about stroke. Retrieved May 12, 2022, from https://www.world-stroke.org/world-stroke-day-campaign/why-stroke-matters/learn-about-stroke
2. Wanda L Rivera-Bou, M. D. (2021, October 17). Thrombolytic therapy: Background, thrombolytic agents, thrombolytic therapy for acute myocardial infarction. Thrombolytic Therapy: Background, Thrombolytic Agents, Thrombolytic Therapy for Acute Myocardial Infarction. Retrieved May 12, 2022, from https://emedicine.medscape.com/article/811234-overview#a7
3. K. Fassbender, C. Balucani, S. Walter, S.R. Levine, A. Haass, J. Grotta; Streamlining of prehospital stroke management: the golden hour; Lancet Neurol., 12 (2013), pp. 585-596
4. Musuka, T. D., Wilton, S. B., Traboulsi, M., & Hill, M. D. (2015). Diagnosis and management of acute ischemic stroke: speed is critical. CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne, 187(12), 887–893. 

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 composed of a synthetic peptide and a free radical scavenger, has demonstrated recanalization capabilities without the increased risk of hemorrhagic transformation. The peptide moiety is modified from the degradation products of fibrinogen and it would block the binding between platelet and fibrinogen, the two major components of thrombus. The small molecule portion is an antioxidant designed to limit oxidative stress and protect tissues from ischemia/reperfusion injury. LT3001, designed to restore occluded blood flow without causing hemorrhage, 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.

LT3001

Development progress

Lumosa has completed a single-dose, randomized, double-blind phase 2a trial of LT3001 in patients with acute ischemic stroke. To expand stroke treatment methodology, Lumosa is pursuing a two-prong development strategy for LT3001 - In the US and China, Phase 2b multi-dose trials will be conducted in the AIS patients left with no treatment options to expand the potential treatable population. Additionally , a Phase 2 trial will be conducted in AIS patients undergoing endovascular thrombectomy to elucidate outcomes. The development and commercial right in Mainland China has 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 :
    Ongoing
  • Link :
  • Stage :
    Phase 1 (LT3001-105)
  • Description :
    Multiple dose on healthy volunteers
  • Region :
    USA
  • Status :
    Ongoing
  • 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 12 hrs)
  • Region :
    China
  • Status :
    Planning
  • Link :
    TBA
  • Stage :
    Phase 2 (LT3001-203)
  • Description :
    Multiple dose with thrombectomy
    (within 24 hrs)
  • Region :
    USA/Taiwan
  • Status :
    Planning
  • Link :
    TBA
  • Stage :
    Phase 2 (LT3001-205)
  • Description :
    Multiple dose on AIS patient
    (within 24 hrs)
  • Region :
    USA
  • Status :
    Planning
  • Link :
    TBA
 

Expanded Access Programs

Expanded use, sometimes called "compassionate use," refers to the use of an investigational drug (that is, a drug that is not FDA-approved) in patients who cannot participate in a clinical trial. Since the eligibility criteria for LT3001 are patients within 24 hours of the stroke onset, which makes the logistic of expanded access infeasible, there will be no expanded access program for LT3001.