Lumosa Therapeutics, in collaboration with CHI Memorial (Chattanooga, USA), has announced the initiation of multiple Phase 2 clinical trials for LT3001, which the company describes as a “groundbreaking” drug for treating acute stroke that combines clot-busting and nerve-protecting effects into one treatment.
LT3001 is intended to extend the critical treatment time window for stroke to 24 hours, offering the potential to “transform” outcomes for many patients, according to a recent Lumosa press release.
Unlike the main drug currently approved by the US Food and Drug Administration (FDA), tissue plasminogen activator (tPA)—which must be administered within 4.5 hours after the onset of stroke symptoms—Lumosa’s LT3001 breaks down clots while also protecting delicate nerve tissues in the brain. The company claims that this novel approach “greatly extends” the therapeutic window to 24 hours, allowing potential treatment for many more stroke victims. Lumosa and CHI Memorial are aiming to “redefine what is possible” in preventing stroke disability and impairment, the release adds.
CHI Memorial—home to the Chattanooga Center for Neurologic Research (CCNR)—serves as the coordinating centre for all Lumosa stroke studies in the USA, and Thomas Devlin (CHI Memorial Neuroscience Institute, Chattanooga, USA) is the international principal investigator for the Lumosa 203 and BRIGHT studies, both of which are Phase 2, randomised, placebo-controlled, double-blinded trials. The trials are focusing on two differing patient populations: those undergoing mechanical thrombectomy (203), and those not undergoing thrombectomy (BRIGHT).
Lumosa states that LT3001’s 24-hour treatment window could be a “gamechanger”, especially for patients in rural areas and those with limited access to immediate care, and its combined clot-dissolving and neuroprotective effects “offer hope for significantly improved outcomes”. LT3001 can be administered within 24 hours after stroke onset for smaller, medium, or larger strokes, in both large and smaller rural hospital emergency departments, potentially expanding patient access to acute stroke therapy.
In December 2023, CHI Memorial achieved enrolment of the first US patient in the Lumosa 203 stroke study. Lumosa’s 203 and BRIGHT trials are anticipated to be completed “in a year or two”, according to the company’s recent release.