Recent Updates
Recently added Catalysts

AstroRx

Phase 1

ALS (Amyotrophic Lateral Sclerosis) | Monoclonal antibody | Neurology |NewcelX Ltd.|Last Updated: Jan 15, 2021

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment16
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03482050A Study to Evaluate Transplantation of Astrocytes Derived From Human Embryonic Stem Cells, in Patients With Amyotrophic Lateral Sclerosis (ALS)PHASE1 COMPLETED 16Apr 12, 2018Jun 22, 2020Jan 15, 20211 Israel
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Number of participants with treatment emergent adverse events as assessed by CTCAE Version 4.03
11 Months

Safety and tolerability assessment will be based on treatment emerged adverse events

Secondary Endpoints
Change in the ALS functional rating scale
11 Months
Change in predicted slow vital capacity (%SVC)
11 Months
Change in muscle strength grading by JAMAR grip strength
11 Months
Unlock Study Endpoints
Study Design & Arms
AllocationNA
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
AstroRxEXPERIMENTAL -
Interventions
NameTypeDescription
AstroRxBIOLOGICALAstrocytes derived from human embryonic stem cells
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 70 Years
SexALL
Healthy VolunteersNo
Study Sites1

Main Inclusion Criteria: 1. El Escorial criteria for probable or definite ALS 2. Males and and non pregnant females between 18 and 70 years of age 3. Patients with an ALS-FRS-R score of at least 30 with an ALS diagnosis of two years or less 4. No history of active psychiatric disorder. Patients rec...

Countries:Israel
Unlock Eligibility Criteria