Novel loberamisal neuroprotectant boosts functional recovery from stroke

Among patients with acute ischaemic stroke, administration of loberamisal, a novel neuroprotective agent, within 48 hours of symptom onset improves functional outcomes, according to the LAIS* trial presented at ISC 2026.

“Neuroprotective agents may help improve patient outcomes since they are aimed at preserving the function of neurovascular units. However, trials for most of these agents have not been successful,” said lead author Dr Shuya Li from Beijing Tiantan Hospital in Beijing, China.

“In this trial, we tested loberamisal, a small-molecule, dual-acting neuroprotective agent that was an effective neuroprotectant in rodent studies. New treatments for stroke may come from multitarget neuroprotective agents, which could lead to important advancements in reducing or preventing disability after a stroke,” she added.

The phase III LAIS trial analysed 998 patients (mean age 63 years, 66 percent male) diagnosed with acute ischaemic stroke (median NIHSS score of 8) who received an intravenous infusion of loberamisal 40 mg once daily for 10 days (n=502) or placebo (n=495) within 48 hours of symptom onset. [ISC 2026, abstract LB032]

At day 90, a greater proportion of patients in the loberamisal group achieved an excellent functional outcome, defined as a modified Rankin Scale score of 0–1, compared with the placebo group (69.7 percent vs 56.3 percent; risk ratio, 1.24). [ISC 2026, abstract LB032]

However, no significant differences were observed in NIHSS change ≥4 from baseline to day 10 (44.7 percent vs 49 percent) and day 30 (73.5 percent vs 72.7 percent) and Barthel index score ≥95 at day 90 (70.7 percent vs 70.4 percent) between the loberamisal and placebo groups.

In an exploratory analysis, depression was assessed using the Montgomery-Asberg Depression Rating Scale (MADRS) and anxiety was evaluated using the Hamilton Anxiety Scale (HAMA).

Results showed that significantly fewer loberamisal-treated patients had depression (MADRS ≥22; 8.6 percent vs 13.1 percent) and anxiety (HAMA ≥21; 8.4 percent vs 12.3 percent) at day 90 relative to those treated with placebo.

In terms of safety, the rates of serious adverse events and all-cause mortality were numerically lower in the loberamisal group vs the placebo group (8.6 percent vs 10.7 percent and 1.2 percent vs 2 percent, respectively).

No SUSARs** were observed in either treatment group, with a reported incidence of zero for both.

Li acknowledged that the study had several limitations, one limitation of the study was that the trial only recruited participants from China, limiting the generalizability of the findings to more diverse populations.

“Overall, loberamisal was associated with a 13-percent absolute increase in the proportion of patients achieving excellent functional outcome at 90 days, with a favourable safety profile,” said Li.

“These findings support further investigation of loberamisal as a novel neuroprotective therapy for acute ischaemic stroke,” she added.