Recent Updates
Recently added Catalysts

BL-7010

Phase 1

Celiac Disease | Small molecule | Gastrointestinal |BioLineRx Ltd.|Last Updated: Aug 18, 2017

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
RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment40
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01990885Safety and Systemic Exposure Study of BL-7010 in Well-Controlled Celiac Patients.PHASE1 COMPLETED 40 — — Dec 1, 2013Oct 1, 2014Aug 18, 20172 Finland
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Incidence of adverse events
For Part 1 subjects will be followed for up to 7 weeks from time of first administration. For Part 2 subjects will be followed for up to 4 weeks from time of first administration
Significant change from baseline in vital signs and 12-lead ECG parameters
For Part 1 subjects will be followed for up to 7 weeks from time of first administration. For Part 2 subjects will be followed for up to 4 weeks from time of first administration
Significant change from baseline in laboratory safety parameters
For Part 1 subjects will be followed for up to 7 weeks from time of first administration. For Part 2 subjects will be followed for up to 4 weeks from time of first administration
Secondary Endpoints
Plasma levels of BL-7010
Over a 24 hour period
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Cohort AEXPERIMENTALEach subject will receive a single administration of either BL-7010 (at different amounts) or matching Placebo on 3 treatment occasions in a randomized double-blind fashion
Cohort BEXPERIMENTALEach subject will receive a single administration of either BL-7010 (at different amounts) or matching Placebo on 3 treatment occasions in a randomized double-blind fashion
Cohort CEXPERIMENTALEach Subject will receive either BL-7010 or Placebo 3 times a day for 14 days(amount to be based on results from Cohorts A and B) in a randomized double-blind fashion
Cohort DEXPERIMENTALEach Subject will receive either BL-7010 or Placebo 3 times a day for 14 days(amount to be based on results from previous cohorts) in a randomized double-blind fashion
Cohort EEXPERIMENTALEach Subject will receive either BL-7010 or Placebo 3 times a day for 14 days(amount to be based on results from previous cohorts) in a randomized double-blind fashion
Interventions
NameTypeDescription
BL-7010DRUG -
PlaceboDRUG -
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Males or females aged 18-75 years who have signed an informed consent form * Body mass index (BMI) between 18.5-29.9, inclusive * Documented history of biopsy-proven celiac disease. * Adherence to a gluten-free diet for the last 6 months prior to randomization * TG2 and EMA an...

Countries:Finland
Unlock Eligibility Criteria
Competitive Landscape -Celiac Disease 5 trials
CompanyTickerTrialsLead PhaseDrugs
Sanofi SA Sponsored ADRSNY1PHASE2Amlitelimab
Forte Biosciences Inc.FBRX1PHASE2FB102
Teva Pharmaceutical Industries Limited Sponsored ADRTEVA1PHASE2TEV-53408
Barinthus Biotherapeutics plc Sponsored ADRBRNS1EARLY_PHASE1VTP-1000
TScan Therapeutics, Inc.TCRX1 — Undisclosed
Unlock Competitive Intelligence