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ILB – Tikomed

Background

ILB is a pleiotropic molecule which means it is believed to have multiple effects in the body. Its active component, a patented form of dextran sulphate, targets multiple pathways that are involved in the loss of function and death of neurons, which is characteristic of MND and other neurological diseases. (Ref: MND Association website).

There are a limited number of animal studies in neurological disease models that have been carried out to date with ILB, but its preclinical safety profile is well established, and the drug has been shown to restore brain energy metabolism after severe traumatic brain injury in rats. Subcutaneously injected (injected under the skin) ILB induces a rapid release of Hepatocyte Growth Factor (HGF) into the circulation in animals and healthy human volunteers, which may provide a key neurotrophic stimulus (critical in the survival of motor neurons) and a myogenic stimulus (can stimulate muscle growth) to degenerating muscle. (Ref: Logan et al, 2022). Preclinical studies from the ILB programme also demonstrated the drug’s ability to enhance endogenous (within the body) repair mechanisms and rebalance inflammatory responses. (Ref: BioSpace).

On 25 May 2022, researchers from TikoMed AB, Sweden, published a paper in PLOS ONE that showed ILB was safe and tolerable in people with MND, and suggested evidence of potential clinical benefits. The clinical trial was a Phase IIa, single-centre, open label, single-arm proof of concept study in a small number of patients, where the primary endpoint was safety and tolerability of subcutaneously administered ILB. To assess possible efficacy in patients with ALS, the trial was conducted in a heterogeneous ALS patient group of intermediate disease severity. (Ref: Logan et al, 2022).

  • ILB administered once a week, by injection, for 5 weeks in 13 people with MND (in Sweden). (Ref: BioSpace).
  • Increased functional scores were seen, assessed using ALSFRS-R scores and Norris clinical rating scales (the Norris clinical rating scale consists of two parts – the Limb Norris Scale, which has 21 items to evaluate extremity function, and the Norris Bulbar scale which has 13 items to evaluate bulbar function). (Ref: Logan et al, 2022), (Ref: Hashizume et al, 2015).
  • Following the ILB injections patients reported increased vitality, decreased muscle stiffness and increased mobility. (Ref: Logan et al, 2022). A decrease in muscle atrophy biomarkers was also seen. (Ref: Logan et al, 2022). 
  • Changes in the functional scores had disappeared 3-4 weeks after the last dosage. (Ref: Logan et al, 2022).

Summary

This pilot clinical study demonstrates safety and tolerability of ILB in people with MND. The exploratory biomarker and functional measures potentially suggest clinical benefit and have a bearing on the mechanism of action of ILB. A larger, randomised, placebo-controlled trial is needed to confirm any suggested clinical benefit seen in this pilot trial.

International Alliance of ALS/MND Associations
March 2024


The original language of communication is English and any translation cannot be guaranteed for accuracy of messaging.

SOURCES

Press release (BioSpace) https://www.biospace.com/article/releases/tikomed-ab-reports-positive phase-ii-clinical-data-for-the-treatment-of-amyothropic-lateral-sclerosis in-data-published-by-plos-one/?s=114

PLOS ONE paper – (Logan et. al, 2022)  https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0267183

ClinicalTrials.gov –  https://clinicaltrials.gov/ct2/show/NCT03705390?term=Tikomed&draw=2& rank=3

Norris scale definition – (A functional scale for spinal and muscular  atrophy: Cross sectional and longitudinal study. Hashizume et al, 2015)  https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5608513/

MND Association website:  https://www.mndassociation.org/research/clinical-trials/treatment trials/ilb/  

Primary Sidebar

Drugs in Development

  • AB Science – Masitinib
  • BrainStorm Cell Therapeutics – NurOwn
  • Clene Nanomedicine – CNM-Au8
  • Collaborative Medicinal Development – CuATSM
  • ILB – Tikomed
  • Kadimastem – AstroRx
  • Methylcobalamin
  • Mitsubishi Tanabe Pharma America – Oral Edaravone
  • Neuronata-R/Lenzumestrocel
  • NeuroSense – PrimeC
  • Neuvivo – NP001
  • T Regulatory Cell Therapies
  • Prilenia Therapeutics – Pridopidine
  • SOD1 Therapies & Trials

  • Duncan Bayly , MND Australia

    Duncan Bayly , MND Australia

  • Timothy Holman, Switzerland

    Timothy Holman, Switzerland

  • March of Faces Photo Submission_ALEX_ELA ARGENTINA

    March of Faces Photo Submission_ALEX_ELA ARGENTINA

  • Feng Gin Sun, Diagnosed 2014 , Shaanxi ALS Association, China

    Feng Gin Sun, Diagnosed 2014 , Shaanxi ALS Association, China

  • Len Johnrose,  MND Association,  Diagnosed 2017,  England

    Len Johnrose, MND Association, Diagnosed 2017, England

  • Jon Newsome, Les Turner ALS Foundation, USA

    Jon Newsome, Les Turner ALS Foundation, USA

  • Steven Spencer, Diagnosed 2014 , MND New Zealand

    Steven Spencer, Diagnosed 2014 , MND New Zealand

  • Ana Lilia RodriguezApoyo Integral Gila A.C., Diagnosed 2018, Mexico

    Ana Lilia RodriguezApoyo Integral Gila A.C., Diagnosed 2018, Mexico

  • Angie Bordaen, Diagnosed 2014,  ALS Liga België, Belgium

    Angie Bordaen, Diagnosed 2014, ALS Liga België, Belgium

  • Fabio Carvalho

    Fabio Carvalho

  • Cath Muir

    Cath Muir
    Cath

  • IMG_1211

    IMG_1211

  • Wilfried Leusing

    Wilfried Leusing

  • Animesh Kumar, Diagnosed 2013 , Asha Ek Hope Foundation, India

    Animesh Kumar, Diagnosed 2013 , Asha Ek Hope Foundation, India

  • Susan Anderson, Diagnosed 2014 , Hope Loves Company,  USA

    Susan Anderson, Diagnosed 2014 , Hope Loves Company, USA

  • Anita Forte, Les Turner ALS Foundation, USA

    Anita Forte, Les Turner ALS Foundation, USA

  • Luis Antonio Pimenta Lima, Brazil

    Luis Antonio Pimenta Lima, Brazil

  • Wiebke Braach, Deutsche Gesellschaft für Muskelkranke, Germany

    Wiebke Braach, Deutsche Gesellschaft für Muskelkranke, Germany

  • Willi Klein

    Willi Klein

  • Jean

    Jean
    jean

  • Lin Yong Yi, Taiwan MND Association, Diagnosed 2004

    Lin Yong Yi, Taiwan MND Association, Diagnosed 2004

  • Joanne Pratt, Diagnosed 2011 , MND Australia

    Joanne Pratt, Diagnosed 2011 , MND Australia

  • Ann Nicol

    Ann Nicol

  • Rolf Mauch, Association ALS Switzerland, Diagnosed 2015

    Rolf Mauch, Association ALS Switzerland, Diagnosed 2015

  • Liz Ogg, Diagnosed 2013 , MND Scotland, UK

    Liz Ogg, Diagnosed 2013 , MND Scotland, UK

  • Yessenia Hernandez Mendoza, Apoyo Integral Gila A.C., Diagnosed 2018, Mexico

    Yessenia Hernandez Mendoza, Apoyo Integral Gila A.C., Diagnosed 2018, Mexico

  • Chun Ju Xiao, China

    Chun Ju Xiao, China

  • Bob Simonds and Drew O'Neil, USA

    Bob Simonds and Drew O’Neil, USA

  • David Solomon, Diagnosed 2015, MND Association of England, Wales and N Ireland

    David Solomon, Diagnosed 2015, MND Association of England, Wales and N Ireland

  • Colm Francis Davis, Ireland

    Colm Francis Davis, Ireland

  • Guoqiang Xu, Diagnosed 2016 , Shaanxi ALS Association, China

    Guoqiang Xu, Diagnosed 2016 , Shaanxi ALS Association, China

  • Kirsty Gerlach, MND New Zealand, Diagnosed 2017

    Kirsty Gerlach, MND New Zealand, Diagnosed 2017

  • Steve

    Steve

  • Claudia Gotti, Brazil

    Claudia Gotti, Brazil

  • Lucy Lintott, Diagnosed 2013 , MND Scotland, UK

    Lucy Lintott, Diagnosed 2013 , MND Scotland, UK

  • Steven Gallagher, Canada

    Steven Gallagher, Canada

  • Gudjon Sigurdsson, Diagnosed 2004 , MND Association of Iceland

    Gudjon Sigurdsson, Diagnosed 2004 , MND Association of Iceland

  • Ian and Teresa Roberts

    Ian and Teresa Roberts

  • Anthony (Tony) Lynch, MND New South Wales, Diagnosed 2016, Australia

    Anthony (Tony) Lynch, MND New South Wales, Diagnosed 2016, Australia

  • Maria Santos Garcia Tellez, Diagnosed 2017 , FYADENMAC, Mexico

    Maria Santos Garcia Tellez, Diagnosed 2017 , FYADENMAC, Mexico

  • Juvenal Bayona Romero

    Juvenal Bayona Romero

  • Shay Rishoni, Diagnosed 2011 - Prize4Life, Israel

    Shay Rishoni, Diagnosed 2011 – Prize4Life, Israel

  • Elkin Ramiro Gaviria Muñoz, Diagnosed December 2018

    Elkin Ramiro Gaviria Muñoz, Diagnosed December 2018

  • Liong Ting Ngu, MND Malaysia, Diagnosed 2014

    Liong Ting Ngu, MND Malaysia, Diagnosed 2014

  • Carlos Alberto Arango, Colombia

    Carlos Alberto Arango, Colombia

  • Malcolm Buck, Australia

    Malcolm Buck, Australia

  • Sébastien Batiot, Diagnosed 2012 , ARSLA, France

    Sébastien Batiot, Diagnosed 2012 , ARSLA, France

  • JP

    JP

  • Ismail Gokcek, Turkey

    Ismail Gokcek, Turkey
    ismail_gokcek_alsmnd_tr

  • Karl Hughes, Diagnosed 2010 , IMNDA,  Ireland

    Karl Hughes, Diagnosed 2010 , IMNDA, Ireland

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