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NeuroSense – PrimeC

Background

PrimeC is a combination therapy composed of two FDA approved drugs: ciprofloxacin and celecoxib. PrimeC is reported to act by regulating several biological mechanisms associated with motor neuron degeneration in ALS such as inflammation and iron accumulation (ref: Neurosense website and alsnewstoday). 

PrimeC has shown promising data in preclinical models of ALS. Data from Justin Ichida’s lab at University of Southern California (USC) showed that PrimeC was able to increase cell survival rate in patient derived neurons in a dish (ref: PR Newswire). Additionally, PrimeC treated zebrafish carrying ALS-causing gene mutations, showed improvement in their swimming abilities compared to their untreated peers (ref: Goldsthein et al., 2020). 

NeuroSense launched two phase 1 and one phase 2aclinical trials at single centers in the US and Israel to test the safety and tolerability of PrimeC in humans. Data showed that PrimeC was safe and well tolerated after 12 months (Ref: Salomon-Zimri et al., 2023, ClinicalTrials.gov ID: NCT05232461 , NCT04090684 and  NCT04165850)

Trial Design and Results

In 2022 NeuroSense started a Phase 2b, double-blind clinical trial (PARADIGM) in 69 subjects with ALS. The trial was randomized at a 2:1 ratio to receive PrimeC or placebo for 6 months followed by a 12-month open label extension period (Ref: ClinicalTrials.gov ID: NCT0535790): 

  • The drug or placebo were administered orally twice a day. Subjects were evaluated every 2 months for safety, tolerability, and various efficacy measurements as secondary outcomes (Ref: ClinicalTrials.gov ID: NCT0535790). 
  • This was a multicenter and international study that took place in Italy, Canada and Israel (Ref: ClinicalTrials.gov ID: NCT0535790). 
  • In December 2023, NeuroSense published two press releases indicating that at the 6-month timepoint patients treated with PrimeC showed a slowing of disease that did not reach significance. More specifically, a 29% difference in ALS Functional Rating Scale (ALSFRS) and a 13% difference in the slow vital capacity (SVC, a measurement of respiratory function) was observed (Ref: Neurologylive). Further analysis of the per protocol population reported stronger improvement in the ALSFRS and SVC score (Ref: Neurologylive).
  • In July 2024, NeuroSense published a third press release stating that data from the Opel Label Extension (OLE) showed a decline in ALSFRS score and survival for people who had been taking PrimeC from the start of the trial compared to those who had started on placebo (ref: PR Newswire). Through 2024 NeuroSense met with different regulatory agencies and is now planning a larger phase 3 clinical trial to evaluate Prime C efficacy.

Summary

These clinical studies demonstrate safety and tolerability of PrimeC in people with ALS (Ref: Salomon-Zimri et al., 2023). The secondary functional measures potentially suggest clinical benefit; however, the trial was underpowered for efficacy measures so further trials are necessary for assessing PrimeC efficacy. It is important to note that no peer review data is available on the phase 2b trial and that the data reported here was only published in press releases. Until peer reviewed data is available, it will not be possible to draw any conclusion from the studies here described. 

The Scientific Advisory Council, therefore, encourages NeuroSense to publish their results in a peer reviewed journal and looks forward to the results of the planned phase 3 clinical trial that should allow better understanding of Prime C efficacy. 

Sources

PrimeC boosts survival of motor neurons derived from ALS patients, ALSnewstoday – https://alsnewstoday.com/news/primec-shows-potential-to-slow-als-progression-interim-data-reveal/

Neurosense website – https://www.neurosense-tx.com/primec/ 

PR Newswire – https://www.prnewswire.com/news-releases/neurosenses-primec-demonstrates-outstanding-effect-on-als-survival-in-innovative-ipsc-model-301946965.html 

Goldshtein et al., 2020 – https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7545590/

Salomon-Zimri et al., 2022 –https://www.tandfonline.com/doi/full/10.1080/21678421.2022.2119868

ClinicalTrial.gov ID: NCT04165850-

https://clinicaltrials.gov/study/NCT04165850?term=PrimeC&cond=ALS&rank=3

ClinicalTrial.gov ID: NCT05232461 – https://www.clinicaltrials.gov/study/NCT05232461

ClinicalTrial.gov ID: NCT04090684-

https://clinicaltrials.gov/study/NCT04090684?term=PrimeC&cond=ALS&rank=2

ClinicalTrial.gov ID: NCT0535790-

https://clinicaltrials.gov/study/NCT05357950?cond=ALS&term=NST003&rank=1

Press release (Sept 2022) – https://neurosense.investorroom.com/2022-09-19-NeuroSense-Announces-Peer-Reviewed-Publication-of-PrimeC-Phase-IIa-ALS-Study-in-Amyotrophic-Lateral-Sclerosis-and-Frontotemporal-Degeneration

Press release (Dec 5th 2023) https://www.neurologylive.com/view/als-candidate-primec-meets-primary-safety-secondary-endpoints-phase-2b-paradigm-study 

Press release (Dec 14th 2023) – https://finance.yahoo.com/news/neurosense-reports-data-statistically-significant-142400043.html 

Press release (July 2024) – https://www.prnewswire.com/news-releases/neurosense-demonstrates-statistically-significant-efficacy-and-survival-benefits-in-people-living-with-als-the-promising-results-from-the-12-month-paradigm-study-highlight-primecs-potential-as-a-disease-modifying-drug-302186838.html

International Alliance of ALS/MND Associations
February 2025


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

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Drugs in Development

  • AB Science – Masitinib
  • BrainStorm Cell Therapeutics – NurOwn
  • Clene Nanomedicine – CNM-Au8
  • Collaborative Medicinal Development – CuATSM
  • ILB – Tikomed
  • Kadimastem – AstroRx
  • Methylcobalamin
  • Mitsubishi Tanabe Pharma America – Oral Edaravone
  • Neuronata-R/Lenzumestrocel
  • NeuroSense – PrimeC
  • Neuvivo – NP001
  • T Regulatory Cell Therapies
  • Prilenia Therapeutics – Pridopidine
  • SOD1 Therapies & Trials

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

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

  • Mahmood Anwar, UK

    Mahmood Anwar, UK

  • Carlos Gomez Matallanas, Diagnosed 2014 , FUNDELA, Spain

    Carlos Gomez Matallanas, Diagnosed 2014 , FUNDELA, Spain

  • Mauril Belanger

    Mauril Belanger

  • Danny Reviers, Diagnosed 1979 , ALS Liga België, Belgium

    Danny Reviers, Diagnosed 1979 , ALS Liga België, Belgium

  • Jo Knowlton and her dog, Scotland

    Jo Knowlton and her dog, Scotland

  • Christian Bär, Germany

    Christian Bär, Germany

  • unnamed

    unnamed

  • Horacio Fritzer, Argentina

    Horacio Fritzer, Argentina

  • Elisabeth Zahnd, Switzerland

    Elisabeth Zahnd, Switzerland

  • Graham Johnson, MND Australia

    Graham Johnson, MND Australia

  • Calum Ferguson, Diagnosed 2010 , MND Scotland, UK

    Calum Ferguson, Diagnosed 2010 , MND Scotland, UK

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

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

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

    Glen Elison, ALS Hope Foundation, Diagnosed 2019, USA

  • Lombana, Spain

    Lombana, Spain

  • Maria Lucia Wood Saldanha, Associação Pró-Cura da ELA, Brazil

    Maria Lucia Wood Saldanha, Associação Pró-Cura da ELA, Brazil

  • Jean

    Jean
    jean

  • Duncan Bayly , MND Australia

    Duncan Bayly , MND Australia

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

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

  • Luis Antonio Pimenta Lima, Brazil

    Luis Antonio Pimenta Lima, Brazil

  • Oliver Juenke, DGM, Germany

    Oliver Juenke, DGM, Germany

  • Yolanda Armendariz, Diagnosed 2017 , FYADENMAC, Mexico

    Yolanda Armendariz, Diagnosed 2017 , FYADENMAC, Mexico

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

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

  • England-Lee-Millard, UK

    England-Lee-Millard, UK

  • Roy

    Roy
    roy

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

    Maria Santos Garcia Tellez, Diagnosed 2017 , FYADENMAC, Mexico

  • Valdomiro Xavier Honório, Brazil

    Valdomiro Xavier Honório, Brazil

  • Claudette Sturk, ALS Society of Canada

    Claudette Sturk, ALS Society of Canada
    Picture2

  • March of Faces Photo Submission_OLGA_ELA ARGENTINA

    March of Faces Photo Submission_OLGA_ELA ARGENTINA

  • Leon Ryba, Asociación ELA Argentina

    Leon Ryba, Asociación ELA Argentina

  • Dick Dayton, USA

    Dick Dayton, USA

  • Jan Zuring, Diagnosed 2010 , The Netherlands

    Jan Zuring, Diagnosed 2010 , The Netherlands

  • Enzo Maccarrone, AISLA ONLUS, Italy

    Enzo Maccarrone, AISLA ONLUS, Italy

  • Cath Muir

    Cath Muir
    Cath

  • Sally Pauls, Diagnosed 2006 , Les Turner ALS Foundation

    Sally Pauls, Diagnosed 2006 , Les Turner ALS Foundation

  • Liam Dwyer, England

    Liam Dwyer, England

  • Jon Newsome, USA

    Jon Newsome, USA

  • Wiebke Braach, Deutsche Gesellschaft für Muskelkranke, Germany

    Wiebke Braach, Deutsche Gesellschaft für Muskelkranke, Germany

  • Inta Grubb, Diagnosed 2014,  MND Australia

    Inta Grubb, Diagnosed 2014, MND Australia

  • Mike Rannie,  ALS Canada,  Diagnosed 2017

    Mike Rannie, ALS Canada, Diagnosed 2017

  • Jose Espinosa, Argentina

    Jose Espinosa, Argentina

  • Soledad Rodriguez, FUNDELA, Diagnosed 2013, Spain

    Soledad Rodriguez, FUNDELA, Diagnosed 2013, Spain

  • Kris Van Reusel, Belgium

    Kris Van Reusel, Belgium

  • Andrietta

    Andrietta

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

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

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

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

  • Orlando Ruiz, Diagnosed 2001,  ACELA, Colombia

    Orlando Ruiz, Diagnosed 2001, ACELA, Colombia

  • Shay Rishoni, Diagnosed 2011 - Prize4Life, Israel

    Shay Rishoni, Diagnosed 2011 – Prize4Life, Israel

  • Stephanie Christiansen Hall, Canada

    Stephanie Christiansen Hall, Canada

  • Carlos Alberto Báez Murillo, ACELA, Colombia

    Carlos Alberto Báez Murillo, ACELA, Colombia

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