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Cytokinetics – Reldesemtiv

Cytokinetics – Reldesemtiv

Background

Cytokinetics is a company that was founded in 1997 to develop treatments targeting impairments in muscle function. 

Cytokinetics has recently tested reldesemtiv after previously working on their initial ALS drug tirasemtiv. Tirasemtiv showed promising results in a Phase 2 clinical trial (BENEFIT-ALS) in 2014, and was followed by a phase 3 clinical trial (VITALITY-ALS) that failed to show any significant positive effects on the disease. One of the key problems with tirasemtiv was tolerability. Despite targeting muscle, it also entered the brain and caused nausea, dizziness and other symptoms that were considered safe, but not particularly tolerable, as it caused participants to drop out of trials, thereby reducing the statistical power needed to determine any benefit. 

Prior to the completion of the phase 3 trial, Cytokinetics also began a phase 2 trial of reldesemtiv, which had all the muscle benefits of tirasemtiv, but without the ability to cross the blood-brain barrier into the central nervous system and cause the unwanted side effects of dizziness and nausea. This was a large phase 2 clinical trial (over 400 participants) that had vastly improved tolerance but did not meet it’s goals of showing statistically significant slowing of breathing capacity, disease progression rate or muscle strength. However, as the dosing was only for 12 weeks and the trends were in the direction of a positive result, the interpretation is not necessarily that of a failed trial, but rather one that would need further testing to determine if reldesemtiv has value for treating ALS. 

Cytokinetics is currently recruiting for a phase 3 clinical trial, which began in 2021, called Clinical Outcomes Using Reldesemtiv on ALSFRS-R in a Global Evaluation of ALS (COURAGE-ALS), with a goal of enrolling 555 participants at sites across multiple countries. For further information visit https://www.courage-als.com

Recommendation

Currently there is no knowledge as to whether reldesemtiv works to improve muscle function or slow disease progression in ALS. Results from the reldesemtiv phase 2 clinical trial show increased tolerance and safety compared to tirasemtiv. The potentially promising results on disease progression, breathing function and muscle strength will require the forthcoming phase 3 clinical trial to confirm any potential significance. 

 

International Alliance of ALS/MND Associations
February 2021

 


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

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Drugs in Clinical Trial

  • AB Science – Masitinib
  • Amylyx – AMX0035
  • Biogen – Tofersen
  • BrainStorm Cell Therapeutics – NurOwn
  • Clene Nanomedicine – CNM-Au8
  • Collaborative Medicinal Development – CuATSM
  • Cytokinetics – Reldesemtiv
  • Kadimastem – AstroRx
  • Mitsubishi Tanabe Pharma America – Oral Edaravone
  • Orphazyme – Arimoclomol
  • T Regulatory Cell Therapies

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    Charlie “Hark” Dourney, Diagnosed 2007 – Hark ALS, USA

  • Cath Muir

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  • Kirsten Harley, Diagnosed 2013 - Australia

    Kirsten Harley, Diagnosed 2013 – Australia

  • Ann Nicol

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  • Alejandro Aquino, Diagnosed 2011 - Asociación ELA Argentina

    Alejandro Aquino, Diagnosed 2011 – Asociación ELA Argentina

  • Shay Rishoni, Diagnosed 2011 - Prize4Life, Israel

    Shay Rishoni, Diagnosed 2011 – Prize4Life, Israel

  • Erwin Coppejans, Diagnosed 2007 - ALS Liga België, Belgium

    Erwin Coppejans, Diagnosed 2007 – ALS Liga België, Belgium

  • Guido De Mets, Belgium

    Guido De Mets, Belgium

  • Zabun Nassar, MND Association, Diagnosed 2016, England

    Zabun Nassar, MND Association, Diagnosed 2016, England

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

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

  • Art Eggert, USA

    Art Eggert, USA

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

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

  • Colm Francis Davis, Ireland

    Colm Francis Davis, Ireland

  • David Watson, MND Scotland, Diagnosed 2018, Scotland

    David Watson, MND Scotland, Diagnosed 2018, Scotland

  • Fabio Correia

    Fabio Correia

  • UK-Mahmood-Anwar

    UK-Mahmood-Anwar

  • Mark Miller

    Mark Miller

  • Zelina-Brito-Diagnosed-2018-Brazil

    Zelina-Brito-Diagnosed-2018-Brazil

  • England-Lee-Millard, UK

    England-Lee-Millard, UK

  • Roxana Canova, Diagnosed 2012 - Asociación ELA Argentina

    Roxana Canova, Diagnosed 2012 – Asociación ELA Argentina

  • Glen Elison, ALS Hope Foundation, Diagnosed 2019, USA

    Glen Elison, ALS Hope Foundation, Diagnosed 2019, USA

  • Juvenal Bayona Romero

    Juvenal Bayona Romero

  • Karl Hughes, Diagnosed 2010 - IMNDA, Ireland

    Karl Hughes, Diagnosed 2010 – IMNDA, Ireland

  • Steven Spencer, Diagnosed 2014 - MND New Zealand

    Steven Spencer, Diagnosed 2014 – MND New Zealand

  • Roy

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  • Monica Soriano, Diagnosed 2011 - Asociación ELA Argentina

    Monica Soriano, Diagnosed 2011 – Asociación ELA Argentina

  • Steven Gallagher, Canada

    Steven Gallagher, Canada

  • Fabrice Kamp, Germany

    Fabrice Kamp, Germany

  • Peng Yi-Wen

    Peng Yi-Wen

  • Sanjay Kumar Srivastava, Asha Ek Hope Foundation for ALS/MND, Diagnosed 2018, India

    Sanjay Kumar Srivastava, Asha Ek Hope Foundation for ALS/MND, Diagnosed 2018, India

  • Fernando Ocampo Cardona, Colombia

    Fernando Ocampo Cardona, Colombia

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

    Brigitte Wernli, Association ALS Switzerland, Diagnosed 2014, Switzerland

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

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

  • Claire Garry, USA

    Claire Garry, USA
    20200117_214643

  • Duncan Bayly - MND Australia

    Duncan Bayly – MND Australia

  • Orlando Ruiz, Diagnosed 2001 - ACELA, Colombia

    Orlando Ruiz, Diagnosed 2001 – ACELA, Colombia

  • Eddy LeFrançois, Diagnosed 1992 - ALS Canada

    Eddy LeFrançois, Diagnosed 1992 – ALS Canada

  • John and Loretta Russo, USA

    John and Loretta Russo, USA
    final3878

  • Chris McCauley, Diagnosed 2015 - ALS Canada

    Chris McCauley, Diagnosed 2015 – ALS Canada

  • Robbie Caliste, UK

    Robbie Caliste, UK

  • Jo Knowlton and her dog, Scotland

    Jo Knowlton and her dog, Scotland

  • Philip Brindle, MND Association, Diagnosed 2015, England

    Philip Brindle, MND Association, Diagnosed 2015, England

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

    Susan Anderson, Diagnosed 2014 – Hope Loves Company, USA

  • Steve Lufkin, USA

    Steve Lufkin, USA
    IMG_3993

  • David Bishop

    David Bishop

  • Phil Rossall, MND-Association, UK

    Phil Rossall, MND-Association, UK

  • Irene McCaughey, Diagnosed 2011 - MND Australia

    Irene McCaughey, Diagnosed 2011 – MND Australia

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

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

  • Mike Rannie, ALS Canada, Diagnosed 2017, Canada

    Mike Rannie, ALS Canada, Diagnosed 2017, Canada

  • Timothy Holman, Switzerland

    Timothy Holman, Switzerland

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