LT3001 Increases Likelihood of Excellent Functional Outcome After Stroke

In a phase 2 clinical trial (NCT04091945), LT3001 (Lumosa Therapeutics, Taipei, Taiwan) improved functional outcomes 90 days after acute ischemic stroke (AIS). In the study, more participants treated with LT3001 (21.4%) had an excellent functional outcome (mRS 0-1) compared with participants treated with placebo (14.3%). LT3001 treatment was observed to be safe with no evidence of increased symptomatic intracranial hemorrhage (sICH) risk. Although the number of participants was limited, more individuals who received LT3001 had neurologic improvement (NIHSS improvement ≥4 points) at day 30 compared with those who received placebo (NIHSS improvement ≥6 points). LT3001 is a small antioxidant molecule combination with a short peptide to restore blood flow by dissolving clots after a stroke. 

"Considering the extensive global unmet medical need for patients and their families battling stroke, we are extremely pleased by the outcome of this study," said Rongjin Lin, PhD, president and chief executive officer, Lumosa Therapeutics.   

"LT3001 represents a completely novel drug design in stroke treatment—combining thrombolytic and neuroprotective properties into a single molecule which may confer unique efficacy and safety properties permitting an extended treatment window," said Thomas Devlin, MD, PhD, professor of Neurology, University of Tennessee Health Science Center and principal investigator of the study." The results from this landmark study pave the way for future studies where LT3001 can be delivered intravenously within a 24-hour time window, either alone or in combination with mechanical stroke treatment. Such studies potentially represent the most impactful clinical studies in the history of stroke treatment"

The phase 2a clinical study was multicenter double-blind single-dose randomized and had placebo-controlled prospective. The study enrolled 24 participants and evaluated LT3001 in individuals with AIS within 24 hours of having stroke symptoms and ineligible to receive IV recombinant tissue-type plasminogen activator (tPA) and endovascular thrombectomy. The participants were randomly assigned to receive LT3001 or placebo within 24 hours of having an onset of ischemic stroke. All participants in the LT3001 and placebo groups were average age 62 (SD±13) years and 68 (SD±9) years with median NIHSS of 6 and 5 respectively. The median time to treatment was 20 hours and 18.5 hours for participants who received LT3001 and placebo.

"These data show the potential of LT3001 being administered anywhere in the world, either with or without intervention therapy and the patients that were treated with LT3001 had potential for a significant degree of neurological improvement compared to placebo." Dr. Devlin added.