Pursuant to 21 CFR 312.23, this Investigational New Drug application is submitted for SYNAPX-7741, a selective JAK1 inhibitor indicated for moderate-to-severe atopic dermatitis. The proposed Phase II dose-escalation study will enroll 240 subjects across 12 investigational sites.
Patient: 54/F. Reaction: Stevens-Johnson Syndrome (MedDRA 10042033). Suspect drug: SYNAPX-7741 200mg BID. Onset: Day 14 post-initiation. Outcome: Hospitalized — not recovered. Causality: Probable.
The overall clinical development program for SYNAPX-7741 comprised 8 completed studies: 1 Phase I SAD/MAD (n=72), 2 Phase I drug interaction studies, 1 Phase II dose-range finding (n=180), and 4 Phase III pivotal trials (n=2,847 total).
Undesirable effects: Very common (≥1/10): upper respiratory tract infection, headache, nausea. Common (≥1/100 to <1/10): herpes zoster, urinary tract infection, increased blood creatine phosphokinase.
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For Regulatory Affairs Directors · Pharmacovigilance Specialists · Clinical Operations
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Module 2.5 Clinical Overview — SYNAPX-7741 The overall clinical program comprised 8 completed studies enrolling 2,847 subjects. The Phase III pivotal trial (SYNAPX-301) demonstrated statistically significant improvement in IGA response at Week 16 (52.3% vs 18.7% placebo; p<0.001) in patients with moderate-to-severe atopic dermatitis (ICD-10: L20.9). Serious adverse events occurred in 4.2% of SYNAPX-7741 200mg BID subjects versus 3.1% placebo. Two cases of Stevens-Johnson Syndrome (MedDRA: 10042033) were reported as possibly related. No deaths attributable to study drug were recorded across the development program. Dose: 200mg BID administered orally. Duration: 52-week maintenance phase. Primary endpoint met. NDA submission target: Q3 2026.
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