Background
ILB is a pleiotropic molecule which means it is believed to have multiple effects in the body. Its active component, a patented form of dextran sulphate (a complex form of polysaccharide or sugar), is thought to target multiple pathways that are involved in the loss of function and death of neurons, which is characteristic of ALS/MND and other neurological diseases.
There are a limited number of animal studies in neurological disease models that have been published to date with ILB which have established its pre-clinical safety profile. These studies have also shown the drug can restore brain energy metabolism after severe traumatic brain injury in rats. Subcutaneously injected (injected under the skin) ILB induces a rapid release of Hepatocyte Growth Factor (HGF) into the circulation in animals and healthy human volunteers, which may provide a neurotrophic stimulus and a myogenic stimulus, i.e., boosts the health and/or survival mechanisms for neurons and muscle cells, to degenerating muscle. Preclinical studies from the ILB programme also demonstrated positive effects on endogenous (within the body) repair mechanisms and rebalancing of inflammatory responses.
Other clinical trials are currently in progress that are assessing the benefits of HGF administered via injection into the arm and leg muscles of people with ALS/MND.
Trial Design & Results
On 25 May 2022, researchers from TikoMed AB, Sweden, published a paper in PLOS ONE that showed ILB was safe and tolerable in people with ALS/MND, and suggested evidence of some clinical efficacy. The clinical trial was a Phase 2a, single-centre, open label, single-arm proof of concept study of a very small number of patients, where the primary endpoint was safety and tolerability of subcutaneously administered ILB.
As a single-arm open-label study, there is no placebo group to compare outcomes with. In such studies patients often report improvements which can also be due to improved care and access to clinical services which trials provide. It can therefore be difficult to definitively conclude that such trial effects are solely due to the drug being tested.
ILB was administered once a week, by injection, for 5 weeks in 13 people with MND (in Sweden).
A number of clinical benefits were reported in the trial participants including slowing of disease progression, increased mobility and biomarker changes.
The reported benefits decreased 3-4 weeks after the last dosage with disease measurements returning to pre-trial levels by week 7.
A Phase 2 trial has recently commenced in Norway which will be recruiting 116 participants for a 12-month trial. The study is currently recruiting with results expected end of 2028.
Summary
The SAC believes this pilot clinical study appears to demonstrate safety and tolerability of ILB in people with ALS/MND. The exploratory biomarker and functional measures must be cautiously interpreted due to small study numbers and the open-label nature of the trial. We look forward to the outcomes from the larger, randomised, placebo-controlled trial that has recently commenced to confirm any suggested clinical benefit seen in this small pilot trial.
International Alliance of ALS/MND Associations
April 2026
Disclaimer: Consult with a healthcare professional to determine if you could potentially participate in a ILB clinical trial. Always disclose your medical history, including any drugs, natural supplements, or herbal medicines currently being used.
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