• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer
  • Email
  • Facebook
  • LinkedIn
  • Twitter
  • YouTube

International Alliance of ALS/MND Associations

  • Members' Login
  • Contact
  • Join the Alliance
  • Donate
  • What is ALS/MND
  • Find a Member Association
  • Support for PALS & CALS
    • Fundamental Rights for People with ALS/MND and Caregivers
    • Research
      • Voice Preservation
      • Open Science
      • Expanded Access
      • Understanding ALS/MND Research
      • Improving Regulatory Pathways
      • Right to Try
      • US FDA Orphan Drug Designation
      • Unproven (Off-Label) Treatments
      • Open Label Extension
    • Advocacy
      • Advocacy Toolkit
      • Emergency Preparedness Toolkit
      • Equitable Access to Therapies
      • Recommendations for Trial Sponsors
    • Clinical Care
      • Genetic Counselling & Testing
      • Mental Health Support
      • Nursing and Symptom Management
      • Nutrition and Swallowing
      • Occupational Therapy and Activities of Daily Living
      • Physiotherapy and Mobility
      • Respiratory Care
      • Speech Therapy and Communication
      • Support for Family & Caregivers
      • Technology
      • Global Clinic Locator
    • Drugs in Development
      • AB Science – Masitinib
      • BrainStorm Cell Therapeutics – NurOwn
      • Clene Nanomedicine – CNM-Au8
      • Collaborative Medicinal Development – CuATSM
      • ILB – Tikomed
      • Kadimastem – AstroRx
      • Mitsubishi Tanabe Pharma America – Oral Edaravone
      • Neuronata-R/Lenzumestrocel
      • NeuroSense – PrimeC
      • Neuvivo – NP001
      • Prilenia Therapeutics – Pridopidine
      • SOD1 Therapies & Trials
      • T Regulatory Cell Therapies
      • Ulefnersen – Ionis Pharmaceuticals
    • Approved Drugs
      • Nuedexta
      • Radicava/Edaravone
      • Riluzole/Tiglutik
      • Rozebalamin/Methylcobalamin
      • Tofersen/Qalsody
    • Drugs No Longer in Development
      • Amylyx – AMX0035
      • Collaborative Medicinal Development – CuATSM
      • Cytokinetics – Reldesemtiv
      • Orphazyme – Arimoclomol
      • TUDCA Trial
  • Support for Health Professionals
    • Breaking the News in ALS/MND
    • Diagnostic Delay (in development)
  • Events/Programs
    • Calendar of Events/Programs
    • Alliance Meeting
    • Allied Professionals Forum
    • Alliance Webinars
    • ALS/MND Connect
    • Global Day Calendar
    • March of Faces
    • Patient Fellows Program
    • Global CRLI
    • International Symposium
  • About
    • Who We Are
    • ALS/MND Health Literacy Map
    • Board of Trustees
    • Advisory Councils/Committees
      • Scientific Advisory Council
      • PALS and CALS Advisory Council
      • Innovation and Technology Council
      • Advocacy and Public Policy Forum
      • Research Directors Forum
      • Governance Committee
      • Finance Committee
    • Staff
    • History
    • Archives
      • Newsletters
      • Meetings
    • Awards
      • Forbes Norris Award
      • Humanitarian Award
      • Allied Health Professional Award
      • Student Innovation Award
  • Members
    • Member Registration
    • Forgot Password

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/MND such as inflammation and iron accumulation (ref: Neurosense website and alsnewstoday). 

PrimeC has shown promising data in preclinical models of ALS/MND. 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/MND-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 & Results

In 2022, NeuroSense started a Phase 2b, double-blind clinical trial (PARADIGM) in 69 subjects with ALS/MND. 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/MND 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/MND (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 (SAC), 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. 

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.

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

Primary Sidebar

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
  • Prilenia Therapeutics – Pridopidine
  • SOD1 Therapies & Trials
  • T Regulatory Cell Therapies
  • Ulefnersen – Ionis Pharmaceuticals

  • Amparo Muriel Engativa, Colombia

    Amparo Muriel Engativa, Colombia

  • Jean

    Jean
    jean

  • Jorge Melo, ABrELA, Brazil

    Jorge Melo, ABrELA, Brazil

  • Roxana Canova, Diagnosed 2012 ,  Asociación ELA Argentina

    Roxana Canova, Diagnosed 2012 , Asociación ELA Argentina

  • Verónica Isabel Castro Molina, Diagnosed 2014, Argentina

    Verónica Isabel Castro Molina, Diagnosed 2014, Argentina

  • Enzo Maccarrone, AISLA ONLUS, Italy

    Enzo Maccarrone, AISLA ONLUS, Italy

  • Ismail Gokcek, Turkey

    Ismail Gokcek, Turkey
    ismail_gokcek_alsmnd_tr

  • Liam Dwyer, England

    Liam Dwyer, England

  • Art Eggert, USA

    Art Eggert, USA

  • Shay Rishoni, Diagnosed 2011 - Prize4Life, Israel

    Shay Rishoni, Diagnosed 2011 – Prize4Life, Israel

  • Sally Pauls, Diagnosed 2006 , Les Turner ALS Foundation

    Sally Pauls, Diagnosed 2006 , Les Turner ALS Foundation

  • Emilienne Verhaegen, ALS Liga Belgium, Diagnosed 2014

    Emilienne Verhaegen, ALS Liga Belgium, Diagnosed 2014

  • Margarita Pizarro, Asociacion ELA Argentina, Diagnosed 2017, Argentina

    Margarita Pizarro, Asociacion ELA Argentina, Diagnosed 2017, Argentina

  • Timmy, ALS Liga

    Timmy, ALS Liga

  • Steven Gallagher, Canada

    Steven Gallagher, Canada

  • Willi Klein

    Willi Klein

  • Hans Dieter Olszewski, Diagnosed 2010 , DGM, Germany

    Hans Dieter Olszewski, Diagnosed 2010 , DGM, Germany

  • Oliver Juenke, Germany

    Oliver Juenke, Germany

  • Mike Rannie,  ALS Canada,  Diagnosed 2017

    Mike Rannie, ALS Canada, Diagnosed 2017

  • Chris McCauley, Diagnosed 2015 , ALS Canada

    Chris McCauley, Diagnosed 2015 , ALS Canada

  • Calum Ferguson, Diagnosed 2010 , MND Scotland, UK

    Calum Ferguson, Diagnosed 2010 , MND Scotland, UK

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

    Guoqiang Xu, Diagnosed 2016 , Shaanxi ALS Association, China

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

    Danny Reviers, Diagnosed 1979 , ALS Liga België, Belgium

  • Yolanda Armendariz, Diagnosed 2017 , FYADENMAC, Mexico

    Yolanda Armendariz, Diagnosed 2017 , FYADENMAC, Mexico

  • Chen Yin Xue, Taiwan MND Association, Diagnosed 1995, Taiwan

    Chen Yin Xue, Taiwan MND Association, Diagnosed 1995, Taiwan

  • Conny van der Meijden, Diagnosed 2001,  ALS Netherlands

    Conny van der Meijden, Diagnosed 2001, ALS Netherlands

  • Joyce Rusinak, Forbes Norris ALS Center, USA

    Joyce Rusinak, Forbes Norris ALS Center, USA

  • Carlos Alberto Báez Murillo, ACELA, Colombia

    Carlos Alberto Báez Murillo, ACELA, Colombia

  • Frank "Papa" Taylor

    Frank “Papa” Taylor

  • Dad

    Dad

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

    Erwin Coppejans, Diagnosed 2007 , ALS Liga België, Belgium

  • Duncan Bayly , MND Australia

    Duncan Bayly , MND Australia

  • Liong Ting Ngu, MND Malaysia, Diagnosed 2014

    Liong Ting Ngu, MND Malaysia, Diagnosed 2014

  • Maurice LeClerc, ALS Canada

    Maurice LeClerc, ALS Canada

  • Steven Spencer, Diagnosed 2014 , MND New Zealand

    Steven Spencer, Diagnosed 2014 , MND New Zealand

  • Luis Antonio Pimenta Lima, Brazil

    Luis Antonio Pimenta Lima, Brazil

  • JP

    JP

  • Feng Gin Sun, Diagnosed 2014 , Shaanxi ALS Association, China

    Feng Gin Sun, Diagnosed 2014 , Shaanxi ALS Association, China

  • Len Johnrose,  MND Association,  Diagnosed 2017,  England

    Len Johnrose, MND Association, Diagnosed 2017, England

  • Alan Liz Ogg 29042016 000799 lo res

    Alan Liz Ogg 29042016 000799 lo res

  • Steve Gallagher, ALS Society of Canada

    Steve Gallagher, ALS Society of Canada
    Picture1

  • Alfredo Santos, Diagnosed 2013 , ACELA, Colombia

    Alfredo Santos, Diagnosed 2013 , ACELA, Colombia

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

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

  • Claudia Cominetti, Associazione conSLAncio Onlus,  Italy

    Claudia Cominetti, Associazione conSLAncio Onlus, Italy

  • Elkin Ramiro Gaviria Muñoz, Diagnosed December 2018

    Elkin Ramiro Gaviria Muñoz, Diagnosed December 2018

  • Dr Shelly Hoover

    Dr Shelly Hoover

  • Hanne Stenmose, Muskelsvindfonden, Denmark

    Hanne Stenmose, Muskelsvindfonden, Denmark

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

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

  • Chen Chun-Chin

    Chen Chun-Chin

  • Bob Simonds and Drew O'Neill , Les Turner ALS Foundation, USA

    Bob Simonds and Drew O’Neill , Les Turner ALS Foundation, USA

Learn more about the March of Faces

Latest Tweets

  • Just now

Footer

Subscribe to our Bi-Monthly Newsletter

Sign up to receive updates and to hear what's going on in the International Alliance of ALS/MND Associations.

"*" indicates required fields

 
This field is for validation purposes and should be left unchanged.
  • Email
  • Facebook
  • LinkedIn
  • Twitter
  • YouTube
Return to top of page

Contact | Disclaimer | Privacy Notice & Cookies | Sitemap

Copyright © 2025 The International Alliance of ALS/MND Associations. All rights reserved.


Registered in England: Charity Number 1079504 · Site built by graphics.coop · Powered by WordPress · Members' login