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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
  • Prilenia Therapeutics – Pridopidine
  • SOD1 Therapies & Trials
  • T Regulatory Cell Therapies
  • Ulefnersen – Ionis Pharmaceuticals

  • Michel Perrozzo, ARSLA, Diagnosed 2015, France

    Michel Perrozzo, ARSLA, Diagnosed 2015, France

  • Mauril Belanger

    Mauril Belanger

  • Alfredo Santos, Diagnosed 2013 , ACELA, Colombia

    Alfredo Santos, Diagnosed 2013 , ACELA, Colombia

  • Margarita Pizarro, Asociacion ELA Argentina, Diagnosed 2017, Argentina

    Margarita Pizarro, Asociacion ELA Argentina, Diagnosed 2017, Argentina

  • Christian Bär, Germany

    Christian Bär, Germany

  • Carlos Alberto Arango, Colombia

    Carlos Alberto Arango, Colombia

  • Liz Ogg, Diagnosed 2013 , MND Scotland, UK

    Liz Ogg, Diagnosed 2013 , MND Scotland, UK

  • Duncan Bayly , MND Australia

    Duncan Bayly , MND Australia

  • Josée Kolijn-de Man, Diagnosed 2015 , ALS Patients Connected, The Netherlands

    Josée Kolijn-de Man, Diagnosed 2015 , ALS Patients Connected, The Netherlands

  • Irene McCaughey, Diagnosed 2011,  MND Australia

    Irene McCaughey, Diagnosed 2011, MND Australia

  • Ada Garrido Benavidez, Diagnosed 2016,  FYADENMAC, Mexico

    Ada Garrido Benavidez, Diagnosed 2016, FYADENMAC, Mexico

  • Soledad Rodriguez, FUNDELA, Diagnosed 2013, Spain

    Soledad Rodriguez, FUNDELA, Diagnosed 2013, Spain

  • Enzo Maccarrone, AISLA ONLUS, Italy

    Enzo Maccarrone, AISLA ONLUS, Italy

  • Maurice LeClerc, ALS Canada

    Maurice LeClerc, ALS Canada

  • Wiebke Braach, Deutsche Gesellschaft für Muskelkranke, Germany

    Wiebke Braach, Deutsche Gesellschaft für Muskelkranke, Germany

  • Lin Yong Yi, Taiwan MND Association, Diagnosed 2004

    Lin Yong Yi, Taiwan MND Association, Diagnosed 2004

  • Mike Small, Motor Neurone Disease (MND) Association, UK

    Mike Small, Motor Neurone Disease (MND) Association, UK

  • 83

    83

  • Jeff Sutherland

    Jeff Sutherland
    jspic

  • Jette Odgaard Villemoes, Muskelsvindfonden, Denmark

    Jette Odgaard Villemoes, Muskelsvindfonden, Denmark

  • Elkin Ramiro Gaviria Muñoz, Diagnosed December 2018

    Elkin Ramiro Gaviria Muñoz, Diagnosed December 2018

  • Jon Newsome, USA

    Jon Newsome, USA

  • Chen Chun-Chin

    Chen Chun-Chin

  • Colm Francis Davis, Ireland

    Colm Francis Davis, Ireland

  • Carlos Gomez Matallanas, Diagnosed 2014 , FUNDELA, Spain

    Carlos Gomez Matallanas, Diagnosed 2014 , FUNDELA, Spain

  • Wilfried Leusing, Diagnosed 2010 , DGM, Germany

    Wilfried Leusing, Diagnosed 2010 , DGM, Germany

  • Zabun Nassar, MND Association, Diagnosed 2016, England

    Zabun Nassar, MND Association, Diagnosed 2016, England

  • Marcel R. Wernard, Diagnosed 2016,  ALS Patients Connected,  The Netherlands

    Marcel R. Wernard, Diagnosed 2016, ALS Patients Connected, The Netherlands

  • Bob Simonds and Drew O'Neill , Les Turner ALS Foundation, USA

    Bob Simonds and Drew O’Neill , Les Turner ALS Foundation, 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

  • Fabio Carvalho, Associação Pró-Cura da ELA, Brazil

    Fabio Carvalho, Associação Pró-Cura da ELA, Brazil

  • Emilienne Verhaegen, ALS Liga Belgium, Diagnosed 2014

    Emilienne Verhaegen, ALS Liga Belgium, Diagnosed 2014

  • Oliver Juenke, DGM, Germany

    Oliver Juenke, DGM, Germany

  • Claudia Gotti, Brazil

    Claudia Gotti, Brazil

  • Sally Pauls, Diagnosed 2006 , Les Turner ALS Foundation

    Sally Pauls, Diagnosed 2006 , Les Turner ALS Foundation

  • H. Todd Kelly, Diagnosed 2013 , ALS Hope Foundation, USA

    H. Todd Kelly, Diagnosed 2013 , ALS Hope Foundation, USA

  • Timmy, ALS Liga

    Timmy, ALS Liga

  • Marcelo Farinelli, Diagnosed 2006, ABrELA, Brazil

    Marcelo Farinelli, Diagnosed 2006, ABrELA, Brazil

  • Sébastien Batiot, Diagnosed 2012 , ARSLA, France

    Sébastien Batiot, Diagnosed 2012 , ARSLA, France

  • Philip Brindle,  MND Association,  Diagnosed 2015,  England

    Philip Brindle, MND Association, Diagnosed 2015, England

  • Ian and Teresa Roberts

    Ian and Teresa Roberts

  • Aida Trzmiel de Guterman, Asociacion ELA Argentina, Diagnosed 2007, Argentina

    Aida Trzmiel de Guterman, Asociacion ELA Argentina, Diagnosed 2007, Argentina

  • Peng Yi-Wen

    Peng Yi-Wen

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

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

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

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

  • Ali Var, Turkey

    Ali Var, Turkey

  • Fabio Carvalho

    Fabio Carvalho

  • Mark Miller

    Mark Miller

  • Brigitte Wernli,  Association ALS Switzerland,  Diagnosed 2014

    Brigitte Wernli, Association ALS Switzerland, Diagnosed 2014

  • Roxana Canova, Diagnosed 2012 ,  Asociación ELA Argentina

    Roxana Canova, Diagnosed 2012 , Asociación ELA Argentina

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