Lumosa Therapeutics has posted positive results from two independent Phase II clinical trials of its lead asset, odatroltide (LT3001) in acute ischemic stroke (AIS).
During the China-only LT3001-202 study (NCT05686642), which aimed to establish odatroltide’s safety and efficacy in moderate AIS patients with disabling symptoms, the drug improved modified Rankin scale (mRS) scores of 0-1 and 0-2 by 8% and 13%, respectively, over placebo.
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Odatroltide also triggered functional outcome improvements in patients with large-artery atherosclerosis (LAA) – with those administered the intravenous (IV) drug experiencing an 11% improvement in mRS 0-2 and a 9% increase in mRS 0-1 compared with placebo. LAA, characterised by a gradual buildup of fatty plaques in the arteries, is often associated with increased AIS risk. The small molecule-peptide conjugate also demonstrated benefits in mismatch-positive patients, with this subgroup achieving a 10% absolute improvement in mRS 0-2.
Meanwhile, the drug also displayed early efficacy signals in the Phase II BRIGHT, or LT3001-205 study (NCT05403866), where 27% of AIS patients with disabling features achieved mRS 0-1 outcomes. This compares with the 17% who achieved this outcome in the placebo cohort.
Both trials evaluated odaltroltide’s efficacy and safety in patients within 24 hours of stroke onset, significantly longer than current approved therapies. They characterised disabling symptoms as significant limb-based motor impairment.
Thomas Devlin, principal investigator on the LT3001-205 trial and director of the CHI Memorial Neuroscience Institute, noted that odatroltide’s safety profile was also favourable, with “no increase in symptomatic intracranial haemorrhage” observed in patients – despite multi-dose administration over three days.
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By GlobalData“LT3001 showed potential benefit beyond the conventional thrombolytic time window, supporting its use in patients ineligible for IV thrombolysis or EVT – a population with high unmet need,” Devlin added.
LT3001 acts through a dual thrombolytic and neuroprotective mechanism. The drug’s peptide portion is designed to bind to the fibrin clot observed in stroke to promote the clot’s breakdown. Meanwhile, the small molecule segment acts as an antioxidant to reduce inflammation within the brain.
Lumosa presented the results of these two trials at the International Stroke Conference, which took place between 4-6 February in New Orleans, Louisiana.
Making steps to treating stroke
While the healthcare sector has made significant strides to improve reperfusion care for patients post-stroke, there is still a lack of approved targeted therapies available to patients.
There are currently two medications that have got the US regulatory greenlight in AIS. This includes Genentech’s TNKase (tenecteplase) and Activase (alteplase) – the former of which became the first drug to gain US approval in this indication in nearly 30 years.
However, more drugs are now in development for the indication – including Bayer’s Factor Xia inhibitor, asundexian. In the Phase III OCEANIC-STROKE study (NCT05686070), the drug reduced the risk of recurrent ischemic stroke by 26%, making it the first drug in its class to demonstrate improvements in this indication over placebo.
Meanwhile, Silver Creek’s insulin-like growth factor 1 (IGF-1) fusion protein, SCP-776, demonstrated improvements in rates of functional independence over placebo in the Phase II ARPEGGIO study (NCT05585606), however improvement on the NIH Stroke Scale (NIHSS) scores what not significantly significant.
