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ILB – Tikomed

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 (a complex
form of polysaccharide or sugar), is thought to target multiple pathways that are
involved in the loss of function and death of neurons, which is characteristic of
ALS/MND and other neurological diseases.

There are a limited number of animal studies in neurological disease models that
have been published to date with ILB, which have established its pre-clinical safety
profile. These studies have also shown the drug can 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 neurotrophic stimulus and a myogenic stimulus, i.e., boosts the health
and/or survival mechanisms for neurons and muscle cells, to degenerating muscle.
Preclinical studies from the ILB programme also demonstrated positive effects on
endogenous (within the body) repair mechanisms and rebalancing of inflammatory
responses.

Other clinical trials are currently in progress that are assessing the benefits of HGF
administered via injection into the arm and leg muscles of people with ALS/MND.

Trail Design and Results

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 ALS/MND, and
suggested evidence of some clinical efficacy (Ref: Logan et al, 2022). The clinical trial
was a Phase 2a, single-centre, open label, single-arm proof of concept study of a
very small number of patients, where the primary endpoint was safety and
tolerability of subcutaneously administered ILB.

  • As a single-arm open-label study, there is no placebo group to compare
    outcomes with. In such studies patients often report improvements which
    can also be due to improved care and access to clinical services which trials
    provide. It can therefore be difficult to definitively conclude that such trial
    effects are solely due to the drug being tested.
  • ILB was administered once a week, by injection, for 5 weeks in 13 people with
    MND (in Sweden).
  • A number of clinical benefits were reported in the trial participants including
    slowing of disease progression, increased mobility and biomarker changes.
  • The reported benefits decreased 3-4 weeks after the last dosage with disease
    measurements returning to pre-trial levels by week 7.
  • It has been reported that further trials are planned although details have yet
    to be released.

Summary

The SAC believes this pilot clinical study appears to demonstrate safety and
tolerability of ILB in people with ALS/MND. The exploratory biomarker and
functional measures must be cautiously interpreted due to small study numbers
and the open-label nature of the trial. A larger, randomised, placebo-controlled trial
is needed to confirm any suggested clinical benefit seen in this small pilot trial.

Primary Sidebar

  • Mary Thomas, Diagnosed 2013 - MND Australia

    Mary Thomas, Diagnosed 2013 – MND Australia

  • Valdomiro Xavier Honório, Brazil

    Valdomiro Xavier Honório, Brazil

  • Luis Antonio Pimenta Lima, Brazil

    Luis Antonio Pimenta Lima, Brazil

  • Duncan Bayly - MND Australia

    Duncan Bayly – MND Australia

  • Jack Buzby, USA

    Jack Buzby, USA

  • Dorette Lüdi, Diagnosed 2014 - ALS Schweiz, Switzerland

    Dorette Lüdi, Diagnosed 2014 – ALS Schweiz, Switzerland

  • Norm MacIsaac, ALS Society of Canada, ALS Society of Quebec, Diagnosed 2014, Canada

    Norm MacIsaac, ALS Society of Canada, ALS Society of Quebec, Diagnosed 2014, Canada

  • Osiel Mendoza, Diagnosed 2016 - ALS Therapy Development Institute, USA

    Osiel Mendoza, Diagnosed 2016 – ALS Therapy Development Institute, USA

  • Elisabeth Zahnd, Switzerland

    Elisabeth Zahnd, Switzerland

  • Len Johnrose, MND Association, Diagnosed 2017, England

    Len Johnrose, MND Association, Diagnosed 2017, England

  • Juvenal Bayona Romero

    Juvenal Bayona Romero

  • Karl Hughes, Diagnosed 2010 - IMNDA, Ireland

    Karl Hughes, Diagnosed 2010 – IMNDA, Ireland

  • Antonio Ventriglia, ALS Liga Belgium, Diagnosed 2013, Belgium

    Antonio Ventriglia, ALS Liga Belgium, Diagnosed 2013, Belgium

  • Amparo Muriel Engativa, Colombia

    Amparo Muriel Engativa, Colombia

  • Joanne Pratt, Diagnosed 2011 - MND Australia

    Joanne Pratt, Diagnosed 2011 – MND Australia

  • Frank "Papa" Taylor

    Frank “Papa” Taylor

  • Steven Spencer, Diagnosed 2014 - MND New Zealand

    Steven Spencer, Diagnosed 2014 – MND New Zealand

  • Monica Soriano, Diagnosed 2011 - Asociación ELA Argentina

    Monica Soriano, Diagnosed 2011 – Asociación ELA Argentina

  • Jon Newsome, Les Turner ALS Foundation, USA

    Jon Newsome, Les Turner ALS Foundation, USA

  • UK-Mahmood-Anwar

    UK-Mahmood-Anwar

  • Ali Var, Turkey

    Ali Var, Turkey

  • Fabrice Kamp, Germany

    Fabrice Kamp, Germany

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

    Susan Anderson, Diagnosed 2014 – Hope Loves Company, USA

  • Christian Bär, Germany

    Christian Bär, Germany

  • Ann Nicol

    Ann Nicol

  • Fernando Ocampo Cardona, Colombia

    Fernando Ocampo Cardona, Colombia

  • Brian Lovell, Diagnosed 2011 - MND Australia

    Brian Lovell, Diagnosed 2011 – MND Australia

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

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

  • Francisco Perez Palop, Diagnosed 2013 - FUNDELA, Spain

    Francisco Perez Palop, Diagnosed 2013 – FUNDELA, Spain

  • Nicholas (Nic) Bowman, MND Association of South Africa, Diagnosed 2016, Australia

    Nicholas (Nic) Bowman, MND Association of South Africa, Diagnosed 2016, Australia

  • Carlos Gomez Matallanas, Diagnosed 2014 - FUNDELA, Spain

    Carlos Gomez Matallanas, Diagnosed 2014 – FUNDELA, Spain

  • Alberto Baez Murillo, Colombia

    Alberto Baez Murillo, Colombia

  • Richard Clark, MND New Zealand, Diagnosed 2011, New Zealand

    Richard Clark, MND New Zealand, Diagnosed 2011, New Zealand

  • Shay Rishoni, Diagnosed 2011 - Prize4Life, Israel

    Shay Rishoni, Diagnosed 2011 – Prize4Life, Israel

  • Margreth Burger-Saile, Diagnosed 2011 - ALS Schweiz, Switzerland

    Margreth Burger-Saile, Diagnosed 2011 – ALS Schweiz, Switzerland

  • Cath Muir

    Cath Muir
    Cath

  • Joy Blakeley, Diagnosed 2017 - MND Australia

    Joy Blakeley, Diagnosed 2017 – MND Australia

  • Roy

    Roy
    roy

  • Zabun Nassar, MND Association, Diagnosed 2016, England

    Zabun Nassar, MND Association, Diagnosed 2016, England

  • Carlos Alberto Arango, Colombia

    Carlos Alberto Arango, Colombia

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

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

  • Chun Ju Xiao, China

    Chun Ju Xiao, China

  • Ian Roberts

    Ian Roberts

  • Robbie Caliste, UK

    Robbie Caliste, UK

  • Conny van der Meijden, Diagnosed 2001 - ALS Netherlands

    Conny van der Meijden, Diagnosed 2001 – ALS Netherlands

  • Brigitte Wernli, Association ALS Switzerland, Diagnosed 2014, Switzerland

    Brigitte Wernli, Association ALS Switzerland, Diagnosed 2014, Switzerland

  • Fabio Correia

    Fabio Correia

  • Daniel Hare

    Daniel Hare

  • Elkin Ramiro Gaviria Muñoz, Diagnosed  December 2018

    Elkin Ramiro Gaviria Muñoz, Diagnosed December 2018

  • Eddy LeFrançois, Diagnosed 1992 - ALS Canada

    Eddy LeFrançois, Diagnosed 1992 – ALS Canada

Learn more about the March of Faces

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