The single-arm, open-label trial involved long-term weekly injections of the low molecular weight dextran sulfate compound. Credit: Darko Stojanovic / Pixabay.

The University of Birmingham in the UK, in collaboration with Swedish pharmaceutical company TikoMed, has published promising results from a Phase II trial of their drug, ILB, for the treatment of amyotrophic lateral sclerosis (ALS).

The single-arm, open-label trial involved long-term weekly injections of the low molecular weight dextran sulfate compound.

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This study was conducted at the University Hospitals Birmingham NHS Foundation Trust by the University of Birmingham’s Drugs, Devices, Diagnostics and Biomarkers (D3B) team from the Cancer Research UK Clinical Trials Unit.

It enrolled 11 subjects who received weekly ILB injections of 2mg/kg for up to 38 weeks.

Results from the trial indicated that the treatment was safe and well-tolerated by patients.

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Minimal side effects and an acceptable safety profile were reported in these 11 patients.

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Furthermore, the ALS Functional Rating Scale-Revised (ALSFRS-R) and the ALS Assessment Questionnaire-40 (ALSAQ-40) scores showed minimal changes over the 48-week reporting period, suggesting a potential slowing of disease progression in the small patient cohort treated with ILB.

Following these positive outcomes, TikoMed is now advancing to plan a Phase IIb multi-centre efficacy trial of ILB.

University of Birmingham Cancer Research UK Clinical Trials Unit, D3B Early Phase Trials Unit clinical lead professor Simon Bach said: “We showed that weekly injection of ILB was safe for patients. We initially planned to deliver ten weeks of treatment to each patient but were able to safely extend treatment up to 38 weeks.

“The study had to stop due to the Covid pandemic. Now that we know that ILB treatment is safe, we can conduct larger studies to find out if this drug slows the progression of motor neuron disease.”