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BDB-001

Phase 2

Hidradenitis Suppurativa | Small molecule | Dermatology |Co-Diagnostics, Inc.|Last Updated: Aug 29, 2023

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
UNCONTROLLED
Total Trials1
Total Enrollment41
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05093855Efficacy and Safety Study of BDB-001 Injection in Patients With Moderate to Severe Hidradenitis Suppurativa (HS)PHASE2 COMPLETED 41Aug 18, 2021Aug 22, 2023Aug 29, 202315 China
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Study Endpoints
Primary Endpoints
Change in International Hidradenitis Suppurativa Severity Score System (IHS4) score from Day 0 by time point
Week 8

The International Hidradenitis Suppurativa Severity Score 4 (IHS4: developed by the European Hidradenitis Suppurativa Foundation Investigator Group),IHS4 Score=(Nodule Count) + (Abscess Count\*2) + (Draining Tunnel Count \*4). IHS4 score uses a range grades: Mild=0-3; Moderate=4-10; Severe ≥11.

Secondary Endpoints
Change in International Hidradenitis Suppurativa Severity Score System (IHS4) score from Day 0 by time point
From Day 0 until Day 56
Change in modified Sartorius Score (mSS) from Day 0 by time point
From Day 0 until Day 56
Change in Hidradenitis Suppurativa Clinical Response (HiSCR) from Day 0 by time point
From Day 0 until Day 56
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Treatment groupEXPERIMENTAL -
Interventions
NameTypeDescription
BDB-001 InjectionDRUGMultiple IV infusions of BDB-001 Injection diluted in sodium chloride
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites15

Inclusion Criteria: * Subjects who signed the informed consent to participate in the STS-BDB001-06 clinical study and completed all follow-up of the study as required by the protocol, or who withdrew early due to treatment failure or other objective reasons and completed the early withdrawal visit ...

Countries:China
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