Oslo University Hospital Launches Phase 2 Trial Comparing ILB® to Standard ALS Treatment

Key Insights

• Oslo University Hospital will conduct a randomized phase 2 trial of ILB® in ALS patients, comparing the experimental drug to Riluzole, the current standard of care.
• The study will enroll 116 patients over 12 months, beginning with a 6-month double-blind phase followed by a 6-month open-label extension where patients receive both treatments.
• Patient enrollment is expected to start in the first quarter of 2026, with results anticipated by the end of 2028.

Oslo University Hospital has announced the startup of a multicentre randomized phase 2 trial evaluating ILB® in amyotrophic lateral sclerosis (ALS) patients, with enrollment expected to begin in early 2026. The study will directly compare the experimental treatment to Riluzole, the current standard of care, in 116 patients over a 12-month period.

Study Design and Timeline

Senior consultant neurologist Dr. Angelina Hatlø Maniaol will serve as the coordinating investigator for the trial, which features a two-phase design. The initial 6-month phase will be a double-blind randomized study where patients receive either Riluzole or ILB®. This will be followed by a 6-month open-label extension phase where all participants will receive both ILB® and Riluzole.

The study is sponsored by Oslo University Hospital and funded through public research grants. Enrollment is restricted to Norwegian residents only, with patient recruitment expected to commence during the first quarter of 2026. Results are anticipated by the end of 2028.

Regulatory Approval and Drug Supply

The trial has received all required regulatory approvals. Tikomed, the Swedish pharmaceutical company developing ILB®, will supply the experimental drug for both study phases as well as the corresponding placebo for the randomized controlled portion of the trial.

About ILB® and ALS Treatment

ILB® is a dextran sulphate that has demonstrated a good safety profile and promising results for ALS treatment in small-scale phase 2a proof-of-concept studies. The drug candidate represents Tikomed's commitment to developing therapies for neurodegenerative conditions and other degenerative disorders.

ALS, also known as Lou Gehrig's disease, is a severe, debilitating and eventually lethal neurodegenerative condition affecting approximately 250-300,000 people worldwide, with approximately 60,000 new cases diagnosed annually. The average lifespan after diagnosis is less than three years, with core symptoms involving declining motor function including inability to swallow and breathe.