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Debamestrocel - MSC-NTF

Phase 3

Amyotrophic Lateral Sclerosis (ALS) | Monoclonal antibody | Neurology |Brainstorm Cell Therapeutics Inc.|Last Updated: May 22, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment200
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06973629Efficacy and Safety of MSC-NTF (NurOwn) in Participants With Early Symptomatic ALS and Moderate Disease Presentation in ALS (ENDURANCE STUDY)PHASE3 NOT YET_RECRUITING 200 — — Jun 30, 2025May 1, 2029May 22, 202515 United States
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Study Endpoints
Primary Endpoints
Change in the ALSFRS-R total score from baseline to Week 24
From baseline to Week 24

To evaluate the efficacy of NurOwn compared to placebo in the treatment of participants with ALS based on the Revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R) which is a 12-item clinician-administered questionnaire. Each item is scored between 0 and 4, with the total ALSFRS-R score between 0 and 48 where a higher score reflects a better outcome.

Frequency and severity of adverse events including treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), death, abnormalities in laboratory evaluations, physical examinations, vital signs and electrocardiogram (ECG) assessments
From baseline to Week 48

To evaluate the safety and tolerability of NurOwn in the treatment of participants with ALS throughout the study including the DBPC period (Part A) to Week 24 and the Open Label Extension (Part B).

Secondary Endpoints
Change in SVC (%predicted) from baseline to Week 24
From baseline to Week 24
Change in HHD from baseline to Week 24
From baseline to Week 24
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Debamestrocel - MSC-NTF (NurOwn)EXPERIMENTALNTF-secreting mesenchymal stem cells (MSC-NTF cells) are a novel cell-therapeutic approach aimed at effectively delivering NTFs directly to the site of damage in ALS patients
PlaceboPLACEBO_COMPARATORPlacebo is comprised of Dulbecco Modified Eagle Medium (DMEM)
Interventions
NameTypeDescription
Debamestrocel - MSC-NTF (NurOwn)BIOLOGICALMSC-NTF cells suspended in excipient Dulbecco Modified Eagle Medium (DMEM).
PlaceboBIOLOGICALDulbecco Modified Eagle Medium (DMEM).
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites15

Inclusion Criteria: 1. Male and female participants 18 to 75 years old (inclusive) at Screening Visit 1. 2. ALS diagnosed as laboratory-supported probable, clinically probable, or definite as defined by the revised El Escorial criteria. 3. Having onset of ALS symptoms, including muscle weakness, wi...

Countries:United States
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