Lumosa Therapeutics announced 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, China Region of China 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"   

According to the World Health Organization (WHO), stroke is the second leading cause of death for people over the age of 60 with approximately 6 million deaths in the world per year. Stroke can be categorized as hemorrhagic (bleeding) or ischemic (lack of blood flow to critical areas of the brain). Studies show ischemic stroke is most common, occurring in about 85% of all stroke cases. Stroke is clearly a disease with significant global unmet medical need. There are 15 million people worldwide who suffer a stroke each year. Although the tPA and surgery are available, 80% of stroke patients are still left with no other treatment options or without desired outcomes.