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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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    Jon Newsome, USA

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    Leon Ryba, Asociación ELA Argentina

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

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    Jon Newsome, Les Turner ALS Foundation, USA

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  • Alberto Baez Murillo, Colombia

    Alberto Baez Murillo, Colombia

  • Leon Ryba, Argentina

    Leon Ryba, Argentina

  • Frank "Papa" Taylor

    Frank “Papa” Taylor

  • Mahmood Anwar, UK

    Mahmood Anwar, UK

  • Elisabeth Zahnd, Switzerland

    Elisabeth Zahnd, Switzerland

  • Liam Dwyer, England

    Liam Dwyer, England

  • Tison, USA

    Tison, USA

  • Oliver Juenke, DGM, Germany

    Oliver Juenke, DGM, Germany

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  • João Marcos Andrietta, Diagnosed 2008 , ABrELA, Brazil

    João Marcos Andrietta, Diagnosed 2008 , ABrELA, Brazil

  • Sébastien Batiot, Diagnosed 2012 , ARSLA, France

    Sébastien Batiot, Diagnosed 2012 , ARSLA, France

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

    Angie Bordaen, Diagnosed 2014, ALS Liga België, Belgium

  • Gudjon Sigurdsson, Diagnosed 2004 , MND Association of Iceland

    Gudjon Sigurdsson, Diagnosed 2004 , MND Association of Iceland

  • Jack Buzby, USA

    Jack Buzby, USA

  • Fabrice Kamp, Germany

    Fabrice Kamp, Germany

  • Xian-Zhang Niu, Diagnosed 2006 , Shaanxi ALS Association, China

    Xian-Zhang Niu, Diagnosed 2006 , Shaanxi ALS Association, China

  • Mauril Belanger

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  • Chun Ju Xiao, China

    Chun Ju Xiao, China

  • Soledad Rodriguez, FUNDELA, Diagnosed 2013, Spain

    Soledad Rodriguez, FUNDELA, Diagnosed 2013, Spain

  • Cassio Fernando da Silva, Diagnosed 2013 , ABrELA, Brazil

    Cassio Fernando da Silva, Diagnosed 2013 , ABrELA, Brazil

  • Zelina Brito, Diagnosed 2018, Brazil

    Zelina Brito, Diagnosed 2018, Brazil

  • Claudia Cominetti, Associazione conSLAncio Onlus,  Italy

    Claudia Cominetti, Associazione conSLAncio Onlus, Italy

  • Mary Thomas, Diagnosed 2013 , MND Australia

    Mary Thomas, Diagnosed 2013 , MND Australia

  • Armando González Gómez, ACELA, Colombia

    Armando González Gómez, ACELA, Colombia

  • Horacio Fritzer, Argentina

    Horacio Fritzer, Argentina

  • John Dinon, MND Australia

    John Dinon, MND Australia

  • Andrea Zicchieri, Associazione conSLAncio Onlus, Italy

    Andrea Zicchieri, Associazione conSLAncio Onlus, Italy
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  • Sharon Corosanite, Diagnosed 2014 , ALS Hope Foundation, USA

    Sharon Corosanite, Diagnosed 2014 , ALS Hope Foundation, USA

  • Oliver Juenke, Germany

    Oliver Juenke, Germany

  • Claudia Gotti, Brazil

    Claudia Gotti, Brazil

  • David Watson,  MND Scotland,  Diagnosed 2018

    David Watson, MND Scotland, Diagnosed 2018

  • Purningam Jacob, Diagnosed 2012 , Asha Ek Hope Foundation, India

    Purningam Jacob, Diagnosed 2012 , Asha Ek Hope Foundation, India

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  • Lachlan Terry,  MND Australia,  Diagnosed 2015

    Lachlan Terry, MND Australia, Diagnosed 2015

  • Mark Miller

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  • Debbie Craghill, USA

    Debbie Craghill, USA

  • Ali Var, Turkey

    Ali Var, Turkey

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

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

  • Dorette Lüdi, Diagnosed 2014 , ALS Schweiz, Switzerland

    Dorette Lüdi, Diagnosed 2014 , ALS Schweiz, Switzerland

Learn more about the March of Faces

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Drugs No Longer in Development

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  • Cytokinetics – Reldesemtiv
  • Orphazyme – Arimoclomol
  • TUDCA Trial

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