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Fixed dose combination Ciprofloxacin/Celecoxib

Phase 2

Amyotrophic Lateral Sclerosis | Small molecule | Neurology |NeuroSense Therapeutics Ltd.|Last Updated: Mar 3, 2021

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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment16
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04165850Open Label Study to Evaluate Ciprofloxacin/Celecoxib Combination in Patients With ALSPHASE2 COMPLETED 16Nov 25, 2019Jan 19, 2021Mar 3, 20211 Israel
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Study Endpoints
Primary Endpoints
Number of participants with one or more treatment-emergent adverse events
15 months

Treatment emergent adverse event is any medical event associated with the drug

Number of patients who discontinued treatment prematurely
15 months

Number of patients whose treatment is stopped prematurely for any reason

Number of patients who discontinued treatment prematurely due to adverse events
15 months

Number of patients whose treatment is stopped prematurely specifically due to adverse events

Number of patients with significant abnormal laboratory values
15 months
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Fixed dose Ciprofloxacin and CelecoxibEXPERIMENTALFixed dose Ciprofloxacin and Celecoxib capsule to be taken thrice daily, total dose 909mg/day
Interventions
NameTypeDescription
Fixed dose combination Ciprofloxacin/CelecoxibDRUGFixed dose Ciprofloxacin and Celecoxib capsule to be taken thrice daily, total dose 909mg/day
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Able to comprehend and willing to sign an Informed Consent Form (ICF) 2. Males or females between the ages of 18 and 75 years of age, inclusive 3. Diagnosis of familial or sporadic ALS (defined as meeting the laboratory-supported probable, probable, or definite criteria for a...

Countries:Israel
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