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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
  • ILB – Tikomed
  • Methylcobalamin
  • Mitsubishi Tanabe Pharma America – Oral Edaravone
  • Orphazyme – Arimoclomol
  • T Regulatory Cell Therapies

  • Philip Brindle, MND Association, Diagnosed 2015, England

    Philip Brindle, MND Association, Diagnosed 2015, England

  • Alberto Baez Murillo, Colombia

    Alberto Baez Murillo, Colombia

  • Monica Soriano, Diagnosed 2011 - Asociación ELA Argentina

    Monica Soriano, Diagnosed 2011 – Asociación ELA Argentina

  • Karl Hughes, Diagnosed 2010 - IMNDA, Ireland

    Karl Hughes, Diagnosed 2010 – IMNDA, Ireland

  • Jon Newsome, Les Turner ALS Foundation, USA

    Jon Newsome, Les Turner ALS Foundation, USA

  • Luis Antonio Pimenta Lima, Brazil

    Luis Antonio Pimenta Lima, Brazil

  • Duncan Bayly - MND Australia

    Duncan Bayly – MND Australia

  • Colm Francis Davis, Ireland

    Colm Francis Davis, Ireland

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

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

  • Chen Chun-Chin

    Chen Chun-Chin

  • Catherine Pearce, Australia

    Catherine Pearce, Australia

  • Peng Yi-Wen

    Peng Yi-Wen

  • Joyce Rusinak, Forbes Norris ALS Center, USA

    Joyce Rusinak, Forbes Norris ALS Center, USA

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

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

  • Joy Blakeley, Diagnosed 2017 - MND Australia

    Joy Blakeley, Diagnosed 2017 – MND Australia

  • UK-Mahmood-Anwar

    UK-Mahmood-Anwar

  • Chris McCauley, Diagnosed 2015 - ALS Canada

    Chris McCauley, Diagnosed 2015 – ALS Canada

  • Liong Ting Ngu, MND Malaysia, Diagnosed 2014, Malaysia

    Liong Ting Ngu, MND Malaysia, Diagnosed 2014, Malaysia

  • Eddy LeFrançois, Diagnosed 1992 - ALS Canada

    Eddy LeFrançois, Diagnosed 1992 – ALS Canada

  • Jack Buzby, USA

    Jack Buzby, USA

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

    Erwin Coppejans, Diagnosed 2007 – ALS Liga België, Belgium

  • Zabun Nassar, MND Association, Diagnosed 2016, England

    Zabun Nassar, MND Association, Diagnosed 2016, England

  • Carlos Alberto Arango, Colombia

    Carlos Alberto Arango, Colombia

  • Francisco Perez Palop, Diagnosed 2013 - FUNDELA, Spain

    Francisco Perez Palop, Diagnosed 2013 – FUNDELA, Spain

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

    Glen Elison, ALS Hope Foundation, Diagnosed 2019, USA

  • Phil Rossall, MND-Association, UK

    Phil Rossall, MND-Association, UK

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

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

  • Lachlan Terry, MND Australia, Diagnosed 2015, Australia

    Lachlan Terry, MND Australia, Diagnosed 2015, Australia

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

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

  • Amparo Muriel Engativa, Colombia

    Amparo Muriel Engativa, Colombia

  • Denis Blais, Diagnosed 2015 - ALS Canada

    Denis Blais, Diagnosed 2015 – ALS Canada

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

    Angie Bordaen, Diagnosed 2014 – ALS Liga België, Belgium

  • Robbie Caliste, UK

    Robbie Caliste, UK

  • Ali Var, Turkey

    Ali Var, Turkey

  • Oliver Juenke, DGM, Germany

    Oliver Juenke, DGM, Germany

  • Steve Lufkin, USA

    Steve Lufkin, USA
    IMG_3993

  • Mark Miller

    Mark Miller

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

    Brigitte Wernli, Association ALS Switzerland, Diagnosed 2014, Switzerland

  • Mike Rannie, ALS Canada, Diagnosed 2017, Canada

    Mike Rannie, ALS Canada, Diagnosed 2017, Canada

  • Claire Garry, USA

    Claire Garry, USA
    20200117_214643

  • Inta Grubb, Diagnosed 2014 - MND Australia

    Inta Grubb, Diagnosed 2014 – MND Australia

  • Timothy Holman, Switzerland

    Timothy Holman, Switzerland

  • Chun Ju Xiao, China

    Chun Ju Xiao, China

  • Christian Bär, Germany

    Christian Bär, Germany

  • Steven Gallagher, Canada

    Steven Gallagher, Canada

  • Kirsten Harley, Diagnosed 2013 - Australia

    Kirsten Harley, Diagnosed 2013 – Australia

  • Fernando Ocampo Cardona, Colombia

    Fernando Ocampo Cardona, Colombia

  • Juvenal Bayona Romero

    Juvenal Bayona Romero

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

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

  • Fabio Correia

    Fabio Correia

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