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International Alliance of ALS/MND Associations

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Collaborative Medicinal Development – CuATSM

Background

In 2018, an Australian company called Collaborative Medicinal Development; LLC released results from a Phase 1 clinical trial for a compound called CuATSM. Later trials (Phase 2 or 3) would be designed to further examine safety and to eventually determine if CuATSM had the characteristics to alter ALS/MND disease progression. 

On January 7th, 2019, television spots and a media stated that CuATSM slowed disease progression in the Phase 1 clinical trial participants (Newswire press release). However, this Phase 1 trial was designed to only determine safety and dosing of CuATSM. These statements resulted in an international outcry for people living with ALS/MND to access CuATSM. Further studies, however, were required to provide any indication that CuATSM could have any effect on ALS/MND disease progression.

Trial Design & Results

In late 2019, a Phase 2/3 clinical trial of 80 people started recruiting in Australia (NCT04082832), which was intended to provide potential evidence for a treatment effect. The limited size of this Phase 2/3 trial meant however, that a very large slowing of disease progression would be required for a statistically significant effect to be seen.

The Phase 2/3 trial was completed in late 2021 however, the outcome of the trial has yet to be announced. It is disappointing that Collaborative Medicinal Development, LLC has not announced topline results nor published trial results. 

Summary

The Scientific Advisory Council (SAC) recommends that Alliance members refer to CuATSM as a drug that was recently studied for human safety and tolerability in a small Phase 1 clinical trial by the company Collaborative Medicinal Development, LLC in Australia. It is the opinion of the SAC that, at the doses tested, clinical grade CuATSM is considered safe and well tolerated. However, a press release also states that the company has seen a substantial slowing of disease progression. This Phase 1 clinical trial was not designed to make such a public statement and several aspects in its design require this result to be taken with as much caution as possible. Essentially, there is no substantiated scientific evidence that CuATSM has any advantageous effect on ALS/MND in humans. 

To date, the follow-on trial results have not been published despite the trial completing in 2021. The SAC urges Collaborative Medicinal Development, LLC to report the outcomes of the trial as soon as possible to the community that has supported this trial. However, given that Collaborative Medicinal Development has been unresponsive to this request, the SAC has decided to move this note to the “drugs no longer in development” section of the Alliance website.

Please refer to this MND Association blog for a more detailed explanation.

International Alliance of ALS/MND Associations
November 2024


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

Primary Sidebar

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    Peng Yi-Wen

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    Angela Jansen, Deutsche Gesellschaft für Muskelkranke e.V.-DGM, Diagnosed 1995, Germany

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    83

  • Jose Rivero Muñoz, Diagnosed 2015, FYADENMAC, Mexico

    Jose Rivero Muñoz, Diagnosed 2015, FYADENMAC, Mexico

  • Jon Newsome, USA

    Jon Newsome, USA

  • John and Loretta Russo, USA

    John and Loretta Russo, USA
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  • Bob Simonds and Drew O'Neil, USA

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  • Cath Muir

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  • Armando González Gómez, ACELA, Colombia

    Armando González Gómez, ACELA, Colombia

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

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  • Dr Shelly Hoover

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  • Ian Roberts

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  • Calum Ferguson, Diagnosed 2010 , MND Scotland, UK

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  • Juvenal Bayona Romero

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  • MNDaSG Group PALS & CALS, Motor Neurone Disease Association, Singapore (MNDaSG)

    MNDaSG Group PALS & CALS, Motor Neurone Disease Association, Singapore (MNDaSG)

  • Amparo Muriel Engativa, Colombia

    Amparo Muriel Engativa, Colombia

  • Alejandro Aquino, Diagnosed 2011 , Asociación ELA Argentina

    Alejandro Aquino, Diagnosed 2011 , Asociación ELA Argentina

  • Liam Dwyer, England

    Liam Dwyer, England

  • Inta Grubb, Diagnosed 2014,  MND Australia

    Inta Grubb, Diagnosed 2014, MND Australia

  • Bruno Leanza Mantegna, Diagnosed 1999 , AISLA Onlus, Italy

    Bruno Leanza Mantegna, Diagnosed 1999 , AISLA Onlus, Italy

  • Horacio Fritzer, Argentina

    Horacio Fritzer, Argentina

  • Wilfried Leusing

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  • Bjarne Hytjanstorp, ALS Norge, Norway

    Bjarne Hytjanstorp, ALS Norge, Norway

  • Mike Rannie,  ALS Canada,  Diagnosed 2017

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  • Claudette Sturk, ALS Society of Canada

    Claudette Sturk, ALS Society of Canada
    Picture2

  • Natalya Rybakova, Russia

    Natalya Rybakova, Russia

  • Zelina Brito, Diagnosed 2018, Brazil

    Zelina Brito, Diagnosed 2018, Brazil

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

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

  • Steve Gallagher, ALS Society of Canada

    Steve Gallagher, ALS Society of Canada
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  • Lachlan Terry,  MND Australia,  Diagnosed 2015

    Lachlan Terry, MND Australia, Diagnosed 2015

  • Christian Bär, Germany

    Christian Bär, Germany

  • unnamed

    unnamed

  • Roy

    Roy
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  • Karl Hughes, Diagnosed 2010 , IMNDA,  Ireland

    Karl Hughes, Diagnosed 2010 , IMNDA, Ireland

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

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

  • Brigitte Wernli,  Association ALS Switzerland,  Diagnosed 2014

    Brigitte Wernli, Association ALS Switzerland, Diagnosed 2014

  • Ian and Teresa Roberts

    Ian and Teresa Roberts

  • Mary Thomas, Diagnosed 2013 , MND Australia

    Mary Thomas, Diagnosed 2013 , MND Australia

  • Jason Goodman, Les Turner ALS Foundation, USA

    Jason Goodman, Les Turner ALS Foundation, USA

  • Philip Brindle,  MND Association,  Diagnosed 2015,  England

    Philip Brindle, MND Association, Diagnosed 2015, England

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

    Guoqiang Xu, Diagnosed 2016 , Shaanxi ALS Association, China

  • Sharon Corosanite, Diagnosed 2014 , ALS Hope Foundation, USA

    Sharon Corosanite, Diagnosed 2014 , ALS Hope Foundation, USA

  • Claudia Gotti, Brazil

    Claudia Gotti, Brazil

  • Jose Espinosa, Argentina

    Jose Espinosa, Argentina

  • Eddy LeFrançois, Diagnosed 1992,  ALS Canada

    Eddy LeFrançois, Diagnosed 1992, ALS Canada

  • Lombana, Spain

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  • Frank "Papa" Taylor, USA

    Frank “Papa” Taylor, USA

Learn more about the March of Faces

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Drugs No Longer in Development

  • Amylyx – AMX0035
  • Collaborative Medicinal Development – CuATSM
  • Cytokinetics – Reldesemtiv
  • Orphazyme – Arimoclomol
  • TUDCA Trial

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