Oslo University Hospital announces the startup of a multicentre randomized phase 2 trial of ILB® in ALS, commencing early 2026. The study will compare ILB® to Riluzole, the current standard of care, and will include 116 patients over a 12-month study period.
VIKEN, Sweden, Sept. 1, 2025 /PRNewswire/ -- Senior consultant neurologist Dr Angelina Hatlø Maniaol is coordinating investigator for the study, which will consist of a 6-month double-blind randomized phase where patients will get either Riluzole or ILB, followed by a 6-month open-label extension where patients will get both ILB and Riluzole.
The study is sponsored by Oslo University Hospital, funded by public research grants and is open to Norwegian residents only. Tikomed will supply ILB for both study phases as well as corresponding placebo for the RCT.
The study has received all required regulatory approvals and is expected to start enrolling patients during the first quarter of 2026. Results are expected by the end of 2028.
More information is available on the Oslo University homepage (only in Norwegian):
https://www.oslo-universitetssykehus.no/om-oss/ekspertsykehuset/ny-studie-av-als-medisin-startes-opp-ved-oslo-univeristessykehus-ous/
https://www.oslo-universitetssykehus.no/kliniske-studier/impact-utproving-av-legemiddelet-ilb-ved-als/sjekkliste--detaljer-om-deltakelse
About Tikomed
Tikomed is a privately owned pharmaceutical company based in Viken, Sweden. Tikomed is committed to developing game-changing therapies for neurodegenerative conditions and other degenerative disorders through its drug candidate ILB®, a dextran sulphate which has shown a good safety profile and promising results for the treatment of ALS in small-scale phase 2a proof-of-concept studies. To learn more, visit www.tikomed.com.
About ALS
Amyotrophic Lateral Sclerosis (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 approx. 60,000 new cases annually. The average lifespan after diagnosis is less than three years and core symptoms involve declining motor function including inability to swallow and breathe.
For more information, please contact Tikomed's CMO Dr Björn Pilström, bjorn.pilstrom@tikomed.com.
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https://news.cision.com/tikomed/r/oslo-university-hospital-to-conduct-randomized-phase-2-trial-of-ilb--in-als,c4227363
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