Recent Updates
Recently added Catalysts

ATI355

Phase 1

Acute Spinal Cord Injury | Small molecule | Other |Novartis AG|Last Updated: Feb 11, 2020

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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment52
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00406016Acute Safety, Tolerability, Feasibility and Pharmacokinetics of Intrath. Administered ATI355 in Patients With Acute SCIPHASE1 COMPLETED 52May 1, 2006Sep 1, 2011Feb 11, 202014 Canada, Germany +1
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Feasibility, Safety and Tolerability of a continuous intrathecal (i.t.) infusion or i.t. repeated bolus injections of ATI355 in patients with acute spinal cord injury at every visit and Assessment of serum and CSF pharmacokinetics at predefined visits.
1 year
Secondary Endpoints
Immunogenicity of ATI355 in acute spinal cord injury patients up to one year.
1 year
Early potential signal of efficacy by the American Spinal Cord Injury Association (ASIA) protocol and pharmacodynamic changes assessed by electrophysiology tests for up to one year.
1 year
Unlock Study Endpoints
Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTAL -
Interventions
NameTypeDescription
ATI355DRUG -
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites14

Inclusion criteria * Acute spinal cord injury paraplegic and tetraplegic patients with confirmed classification of ASIA A (C5 ≤ lesion ≤ T12; 4-14 days post-injury (i.e. study drug treatment must begin 4-14 days post injury) for paraplegic patients and for those tetraplegic patients who do not requ...

Countries:CanadaGermanySwitzerland
Unlock Eligibility Criteria