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SBT777101

Phase 1

Hidradenitis Suppurativa | Monoclonal antibody | Dermatology |Sonoma Pharmaceuticals, Inc.|Last Updated: Feb 20, 2026

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
CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment24
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06361836Study of Single Doses of SBT777101 in Subjects With Hidradenitis SuppurativaPHASE1 ACTIVE NOT_RECRUITING 24Oct 9, 2024Nov 1, 2026Feb 20, 20266 United States
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Study Endpoints
Primary Endpoints
Incidence, nature, and severity of adverse events [Safety and Tolerability]
Day of treatment to end of follow-up period (48 weeks)
Incidence and nature of Dose Limiting Toxicities [DLTs]
Day of treatment to end of DLT evaluation period (28 days)
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
SBT777101 Dose Level 1EXPERIMENTALLow dose SBT777101
SBT777101 Dose Level 2EXPERIMENTALMid dose SBT777101
SBT777101 Dose Level 3EXPERIMENTALHigh dose SBT777101
Interventions
NameTypeDescription
SBT777101BIOLOGICALExperimental treatment
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Eligibility Criteria
Age Range18 Years — 70 Years
SexALL
Healthy VolunteersNo
Study Sites6

Inclusion Criteria: * Body mass index (BMI) ≤50 kg/m2, inclusive * Diagnosis of clinically active moderate-to-severe HS (Hurley Stage 2 or 3) * Total abscess or inflammatory nodule (AN) count of ≥5, affecting at least 2 distinct anatomic regions, with at least 1 accessible AN of adequate size for b...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT06361836studyFirstPostDate: changed