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ATR12-351

Phase 1

Netherton Syndrome | Small molecule | Other |Azitra Inc|Last Updated: Feb 5, 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
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment12
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06137157Evaluation of Topical ATR12-351 in Adults With Netherton SyndromePHASE1 RECRUITING 12Jun 19, 2024Aug 1, 2026Feb 5, 20262 United States
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Study Endpoints
Primary Endpoints
Adverse events
84 days

Incidence, severity, seriousness and relatedness of all treatment-emergent adverse events

Secondary Endpoints
Investigator's Global Assessment (IGA)
42 days
Patient's Global Assessment (PGA)
42 days
NS-modified SCORAD
42 days
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Internal controlled armEXPERIMENTALATR12-351 on left side of body, vehicle on right side of body in one group; vehicle on left side of body, ATR12-351 on right side of body.
Interventions
NameTypeDescription
ATR12-351DRUGTopical ointment containing ATR12-351, a LEKTI-secreting strain of S. epidermidis
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Adults ≥18 years of age * Confirmed mutation of the serine protease inhibitor of Kazal type 5 (SPINK5) gene * Involvement of ≥20% of body surface area with skin changes consistent with Netherton syndrome Exclusion Criteria: * Use of biologic therapies, antibiotics, antihista...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06137157primaryCompletionDate: changed
LOWMay 24, 2026NCT06137157studyFirstPostDate: changed