Lumosa Therapeutics (Lumosa; 6535.TWO) and CHI Memorial have announced the initiation of a Phase 2b clinical trial for LT3001, a groundbreaking drug for treating acute stroke. This new drug combines clot-busting and nerve-protecting effects into one treatment and extends the treatment window to 24 hours, potentially revolutionizing acute stroke therapy.
"Stroke, a leading cause of adult disability globally, hits particularly hard in Chattanooga, an area known as the 'Stroke Belt,' with one of the highest incidences of stroke in the nation," officials said.
"LT3001 aims to extend the critical treatment time window to 24 hours, offering the potential to transform outcomes for countless stroke patients.
"Unlike the current U.S. FDA-approved drug, tissue plasminogen activator (t-PA), which must be administered within 4.5 hours after onset of stroke symptoms, Lumosa’s LT3001 breaks down clots while also protecting delicate nerve tissues in the brain. This novel approach greatly extends the stroke treatment window to 24 hours, allowing potential treatment for many more stroke victims.
"In December 2023, CHI Memorial achieved a significant milestone by enrolling the first U.S. patient in the Lumosa 203, double-blinded stroke study. The patient received a LT3001 study drug in combination with mechanical thrombectomy, or clot removal procedure, for a large stroke. As part of the double-blinded study, the patient could have received the LT3001 drug or a placebo. The patient demonstrated marked improvement and was eventually discharged from the hospital.
"With more than 795,000 strokes annually in the U.S., LT3001’s 24-hour treatment window could be a game-changer, especially for patients in rural areas and those with limited access to immediate care. One of the only two treatments, the mechanical thrombectomy surgery alone for large vessel occlusion stroke, is effective in less than 50% of patients. The other one, t-PA, with the strict 4.5-hour time window, limits the treatment to only about 12 percent of stroke victims nationally. LT3001’s 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, greatly expanding access and reaching more patients within a broader timeframe.
"CHI Memorial, home to Chattanooga Center for Neurologic Research, LLC (CCNR), serves as the coordinating center for all Lumosa stroke studies in the United States. Thomas Devlin, MD, PhD, medical director of the CHI Memorial Neuroscience Institute, acts as the international principal investigator for both the Lumosa 203 and BRIGHT Phase 2b randomized placebo-controlled, double-blinded trials. These trials focus on two patient populations: those undergoing mechanical thrombectomy (203 study, NCT05198323) and those who do not (BRIGHT study, NCT05403866). Both trials address the critical unmet need for more effective stroke treatment.
"Lumosa’s 203 and BRIGHT trials are anticipated to be completed in a year or two. For study 203, Lumosa has partnered with 10 medical centers in the U.S., with CHI Memorial being the only one in Tennessee.
"This groundbreaking initiative aims to redefine stroke treatment possibilities, offering new hope to individuals and families affected by this debilitating condition. Lumosa and CHI Memorial are committed to advancing medical innovation and improving the lives of stroke patients worldwide."