Exploring the Groundbreaking Phase 2 Trial of ILB® for ALS

Exciting Developments in ALS Treatment
Oslo University Hospital is taking a significant step forward in the treatment of Amyotrophic Lateral Sclerosis (ALS) with the commencement of a multicenter randomized phase 2 trial of ILB®. This innovative study aims to compare the efficacy of ILB®, a promising new treatment, against Riluzole, the current standard of care for ALS patients.
The Structure of the Trial
Set to begin in early 2026, this trial will encompass 116 participants over a 12-month period. The study will be spearheaded by senior consultant neurologist Dr. Angelina Hatlø Maniaol, who will oversee a 6-month double-blind phase where patients will receive either Riluzole or ILB®. Following this, there will be a 6-month open-label extension period during which all participants will receive ILB® along with Riluzole.
Support from Tikomed
The trial, sponsored by Oslo University Hospital and funded through public research grants, will exclusively enroll Norwegian residents. In this collaboration, Tikomed will supply ILB® for both the trial phases, alongside the necessary placebos for the randomized controlled trial (RCT).
Anticipated Outcomes
All requisite regulatory approvals have been secured for the study, and patient enrollment is projected to kick off in the first quarter of 2026. The research team hopes to unveil results by the end of 2028, which could pave the way for groundbreaking advancements in ALS treatment protocols.
Understanding ALS
Amyotrophic Lateral Sclerosis, often referred to as Lou Gehrig's disease, poses considerable challenges due to its severe, debilitating nature. Currently, it affects approximately 250,000 to 300,000 individuals globally, with around 60,000 new cases emerging annually. The average survival post-diagnosis is less than three years, marked by a progressive decline in motor function, including severe difficulties with swallowing and breathing.
About Tikomed
Tikomed is a private pharmaceutical company situated in Viken, Sweden, committed to the development of innovative therapies targeting neurodegenerative disorders. Their candidate, ILB®, a dextran sulfate, has demonstrated a strong safety profile and encouraging results in preliminary phase 2a studies for ALS.
Conclusion
The initiative by Oslo University Hospital to conduct this pivotal trial marks a hopeful turn in the quest for effective ALS therapies. Both the medical community and patients eagerly anticipate the outcomes that may emerge from this extensive research effort.
Frequently Asked Questions
What is the focus of the ILB® trial in ALS?
The trial focuses on comparing ILB® with the current standard treatment, Riluzole, to evaluate its effectiveness in ALS patients.
Who is leading the ALS trial?
Dr. Angelina Hatlø Maniaol, a senior consultant neurologist, is the coordinating investigator for the trial.
How many patients will participate in the trial?
The trial aims to enroll 116 patients who will go through a 12-month study period.
When is the anticipated start date for patient enrollment?
Patient enrollment is expected to begin in the first quarter of 2026.
What type of company is Tikomed?
Tikomed is a privately owned pharmaceutical company focused on developing therapies for neurodegenerative conditions, leading efforts to combat diseases like ALS.
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