#Norway #Oslo #Oslo University #ILB® #Tikomed

Oslo University Hospital's Groundbreaking ALS Trial

In a significant advancement for Amyotrophic Lateral Sclerosis (ALS) treatment, Oslo University Hospital has announced the commencement of a multicentre randomized phase 2 trial for ILB®. This trial is set to begin in early 2026 and aims to evaluate the effectiveness of ILB® against Riluzole, the current standard treatment for ALS.

Leading this initiative is Dr. Angelina Hatlø Maniaol, a senior consultant neurologist who serves as the coordinating investigator. The trial is designed to involve 116 patients and will span over a 12-month period. The initial six months will consist of a double-blind study phase, where participants will receive either the new medication ILB® or the established treatment Riluzole. Following this, patients will enter a six-month open-label phase, where they will have access to both ILB® and Riluzole.

Objectives and Benefits of the Study

The primary goal of this trial is to assess the efficacy and safety of ILB® in treating ALS, a debilitating disease affecting hundreds of thousands around the world. The study will not only provide patients with a potential new treatment option but also contribute valuable information regarding ALS therapies. This could have significant implications for future treatment protocols and patient care standards in this challenging medical field.

Funding for the trial comes through public research grants, with Tikomed playing a crucial role by supplying ILB® and corresponding placebo for the randomized controlled trial. Importantly, this study is exclusively open to residents of Norway, which helps streamline participant recruitment and logistics.

Regulatory and Enrollment Process

The trial has secured all necessary regulatory approvals, allowing it to progress swiftly towards patient enrollment. The expectation is to begin this process during the first quarter of 2026, with results anticipated by the end of 2028. These promising developments highlight the commitment of Oslo University Hospital and its partners to tackling neurodegenerative changes that characterize ALS.

Insights into Tikomed and ILB®

Tikomed, a privately owned pharmaceutical company based in Viken, Sweden, specializes in developing transformative therapies aimed at neurodegenerative disorders. Their drug candidate, ILB®, which is derived from dextran sulphate, has already demonstrated a favorable safety profile and positive outcomes in earlier small-scale phase 2a trials. The collaboration with Oslo University Hospital marks a significant step in exploring the therapeutic potential of ILB® for ALS.

Understanding ALS

ALS, or Lou Gehrig's disease, is a life-altering condition that impacts approximately 250,000 to 300,000 individuals globally, resulting in a grim prognosis with an average lifespan of less than three years post-diagnosis. Core symptoms often include declining motor function, leading to severe complications like inability to swallow or breathe without assistance. Through studies like this, the hope is to discover effective treatments that can enhance the quality of life for those affected by such conditions.

The continued efforts of researchers, healthcare professionals, and companies like Tikomed signify a positive outlook for new treatments in the ongoing battle against ALS. For further updates or detailed information about this trial, interested parties can turn to the official Oslo University Hospital website.

This innovative project underscores the importance of clinical trials in the path toward more effective ALS therapies and enhances collaborative efforts within the healthcare community to combat neurodegenerative diseases.