TAIPEI, Aug. 3, 2021 /PRNewswire/ -- Lumosa Therapeutics Co., Ltd. (Lumosa; 6535.TWO) announced today that its Phase 2a clinical trial of LT3001 successfully met its primary safety endpoint. Further, efficacy showed potential for improvements in neurological and functional outcomes based on the majority of LT3001 patients with baseline National Institutes of Health stroke scale (NIHSS) ≥6 demonstrating pronounced neurological improvement (NIHSS improvement ≥4 points). This study was conducted in the U.S. and Taiwan, and was designed to evaluate LT3001 versus placebo/control in subjects with Acute Ischemic Stroke (AIS) within 24 hours after stroke symptoms onset. "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, Ph.D., President & CEO, 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" Lumosa conducted a multicenter, double-blind, single-dose, randomized, and placebo-controlled prospective Phase 2a clinical study in the U.S. and Taiwan. The study enrolled twenty-four subjects and was designed to evaluate LT3001 in AIS patients within 24 hours after stroke symptoms and ineligible to receive IV recombinant tissue-type plasminogen activator (tPA, also known as IV tPA) and/or endovascular thrombectomy. The primary endpoint was the occurrence of symptomatic intracranial hemorrhage (sICH) within 36 hours after dosing. Secondary endpoints include vital measures of efficacy including the mRS (Modified Rankin Score) and change in NIHSS (NIH Stroke Scale). Twenty-four patients were randomly assigned to receive LT3001 or placebo within 24 hours after onset of ischemic stroke. Participants in the LT3001 and placebo groups were a mean age of 62 (SD±13) and 68 (SD±9) years with median NIHSS of 6 ( Range 4-24) and 5 (Range 4-17), respectively. The median time to treatment was 20 and 18.5 hours for patients who received LT3001 and placebo, respectively. Treatment with LT3001 appeared safe with no evidence of increased risk of sICH. While the sample size was limited, more subjects achieved excellent functional outcome (mRS 0-1) at day 90 and pronounced neurological improvement (NIHSS improvement ≥4 points) at day 30 in the LT3001 group. Among participants with baseline NIHSS ≥6 treated with LT3001, 78% showed pronounced neurological improvement.
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