Researchers from the University of Birmingham and Swedish drug development company TikoMed AB have recently published peer reviewed research in PLOS ONE providing additional support that their low molecular weight dextran sulfate compound ILB® is safe and well tolerated in patients with Amyotrophic Lateral Sclerosis (ALS), the most common form of motor neurone disease.
Eleven patients participated in the prospective, single-arm, open-label, phase II clinical trial encompassing long-term weekly ILB® injections for up to 38 weeks of 2 mg/kg.
The trial was carried out at the University Hospitals Birmingham NHS Foundation Trust, by the University of Birmingham’s Drugs, Devices, Diagnostics and Biomarkers (D3B) team from the Cancer Research (UK) Clinical Trials Unit, in collaboration with the pharmaceutical company Tikomed AB who are based in Sweden.
The trial outcomes demonstrated that:
- Long-term weekly ILB® injections of 2 mg/kg were well tolerated, had minimal side-effects and had an acceptable safety profile in all the 11 patients
- ALSFRS-R score* and ALSAQ-40 score** changed minimally over the 48-week reporting period which may indicate a slowing of disease progression in this small ILB® treated patient cohort.
TikoMed is now moving forward with planning a phase IIb multi-centre efficacy trial of ILB®.
