Novel agent to treat ischemic stroke meets safety endpoint in phase 2 study
Lumosa Therapeutics announced its novel agent for patients with acute ischemic stroke met the primary safety endpoint in a phase 2 trial.
The agent (LT3001) was evaluated in a trial of 24 patients with acute ischemic stroke who were ineligible for IV recombinant tissue-type plasminogen activator and/or endovascular thrombectomy, according to a press release from the company. All patients received the agent or placebo within 24 hours of symptom onset.
The primary safety endpoint of symptomatic intracranial hemorrhage at 36 hours was not higher in the LT3001 group than in the placebo group, according to the release.
More patients in the LT3001 group than in the placebo group had pronounced neurological improvement at 30 days, defined as NIH Stroke Scale score improvement of at least 4 points (46.7% vs. 14.3%), and had excellent functional outcome, defined as modified Rankin Scale score of 0 or 1, at 90 days (21.4% vs. 14.3), according to the release.
“LT3001 represents a completely novel drug design in stroke treatment — combining thrombolytic and neuroprotective properties into a single molecule [that] may confer unique efficacy and safety properties permitting an extended treatment window,” Thomas Devlin, MD, PhD, professor of neurology at the University of Tennessee Health Science Center and principal investigator of the study, said in the release. “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 release, the company plans to conduct multidose phase 2b studies in the U.S., China and Taiwan in patients with acute ischemic stroke and no other treatment options, and a phase 2 trial in patients with acute ischemic stroke undergoing endovascular thrombectomy.