Swedish company TikoMed announces successful outcome of phase II safety trial on patients with confirmed Amyotrophic Lateral Sclerosis (ALS) treated with weekly ILB® injections
Press release follows here:
TikoMed announces the publication of results from an open-label, single arm, single center phase II trial carried out at the Queen Elizabeth Hospital, Birmingham, UK, by the University of Birmingham’s Drugs, Devices, Diagnostics and Biomarkers (D3B) team in patients with confirmed Amyotrophic Lateral Sclerosis (ALS) treated with weekly ILB® injections.
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®
Viken, Sweden July 22nd, 2024: Swedish drug development company TikoMed AB today announced the publication in PLOS ONE of peer-reviewed research providing additional support that their low molecular weight dextran sulfate compound ILB® is safe and well tolerated in patients with ALS. Eleven patients participated in the prospective, single-arm, open-label, phase II clinical trial encompassing long-term weekly ILB® injections for up to 48 weeks of 2 mg/kg, a dose that was twice that of the dosing of similar patients in a previously published shorter term clinical safety study.1
The principal investigator of the Birmingham trial, Venkataramanan Srinivasan, MRCP, MRCP (Neurology) of the Queen Elizabeth Hospital comments: “This trial demonstrated the good safety profile of long-term weekly injected ILB® in patients with ALS. I am very grateful for the engaging participation by the patients in especially difficult circumstances due to the onset of the pandemic during the trial period.”
TikoMed’s Scientific Advisor, Professor Ann Logan, Honorary Professor of Regenerative Medicine at the University of Warwick, states: “Taken together, the previous study at the Sahlgrenska Hospital in Gothenburg and the more recent Birmingham trial demonstrate the safety and tolerability of ILB® in patients with ALS and further suggest a long-term slowing of disease progression in addition to the already reported rapid improvements in patient biochemistry and residual motor function. The delivery of fast functional benefit alongside long-term disease stabilisation would make ILB® a unique treatment option for this devastating disease. These encouraging results indicate the future potential of ILB® to be the first disease-modifying drug to treat both familial and sporadic ALS with minimal side-effects.”
“This trial represents another significant milestone for the company, and I am very impressed and grateful that the trial results are now peer-reviewed and published. I also want to extend my sincere thanks to all teams involved for their extraordinary dedication and effort in working towards finding a treatment that could improve the lives of ALS patients,” says Lars Bruce, one of the founders of TikoMed and responsible for the ILB® program.
*ALSFRS-R score: A predictor of survival time in ALS patients
**ALSAQ-40: A disease-specific health-related quality of life instrument for use in studies of patients with ALS or other motor neuron diseases
The clinical trial:
EudraCT 2017-005065-47 and clinicaltrials.gov: NCT03705390.
Sponsor: This clinical trial was undertaken independently with academic leads (VS, SPB), via the Drugs, Devices, Diagnostics and Biomarkers Team (D3B) at Birmingham’s Cancer Research UK Clinical Trials Unit and was sponsored by the University of Birmingham.
Funding: TikoMed AB provided support in the form of salary contribution for some authors as part of the clinical trial funding, but did not have any additional role, either direct or indirect, in the clinical trial study design, data collection, data analysis, decision to publish, or preparation of the manuscript through the participation of the co-authors.
The published article: Srinivasan V, Homer V, Barton D, Clutterbuck-James A, Jenkins S, Potter C, Brock K, Logan A, Smith D, Bruce L, Nagy Z and Bach S.P (2024) A low molecular weight dextran sulphate, ILB®, for the treatment of amyotrophic lateral sclerosis (ALS): An open-label, single-arm, single-centre, phase II trial. PLoS ONE 19(7): e0291285. https://doi.org/10.1371/journal.pone.0291285
For more information:
TikoMed, Christian Treschow, Chairman,
TikoMed, Lars Bruce, responsible for of the ILB® program
To the editors
About TikoMed
TikoMed is a Swedish, private company founded in 2002 by the Bruce family. Lars Bruce, who is the lead of the ILB® program, is an entrepreneur and inventor with several commercial inventions in mechanics, metallurgy and medicine.
Inventor Lars Bruce refers to the drug, called ILB®, as the discovery of the ‘Missing Link’ that can orchestrate the body’s natural tissue repair signals. ILB® is a drug that directly addresses the dysregulated neuro-degenerative and neuro-inflammatory processes that underlie many neuronal diseases through endogenous activation of a unique repertoire of growth factors.
About D3B
The Drugs, Devices, Diagnostics and Biomarkers (D3B) collaborative was established in August 2016 to support design and delivery of high-quality, early phase translational research within Birmingham Health Partners (BHP). D3B is located at the heart of Birmingham’s Institute of Translational Medicine (ITM) with team members derived from Birmingham’s Cancer Research UK Clinical Trials Unit (CRCTU). D3B was created to support development of a research portfolio that aligned with the Government’s strategy for UK Life Sciences; this aims to provide patients with early access to novel treatments.
Publications:
- Logan A, Nagy Z, Barnes NM, Belli A, Di Pietro V, Tavazzi B, Lazzarino G, Lazzarino G, Bruce L, Persson LI. (2022) A phase II open label clinical study of the safety, tolerability and efficacy of ILB® for Amyotrophic Lateral Sclerosis. PLoS One 17(5):e0267183. https://doi.org/10.1371/journal.pone.0267183 PMID: 35613082; PMCID: PMC9132272.