Clinical bioanalytical and PK/PD platform Locked Clinical bioanalytical and PK/PD platform
IND CMC and Phase 1 supply Locked IND CMC and Phase 1 supply
Phase 2 and commercial-intent CMC bridge Locked Phase 2 and commercial-intent CMC bridge
Integrated potency and selectivity package Locked Integrated potency and selectivity package
In vivo colitis efficacy and PK/PD Locked In vivo colitis efficacy and PK/PD
ADME, metabolite, DDI, and human PK prediction Locked ADME, metabolite, DDI, and human PK prediction
Core safety pharmacology and genotoxicity Locked Core safety pharmacology and genotoxicity
GLP 28-day repeat-dose toxicology Locked GLP 28-day repeat-dose toxicology
13-week and Phase 2-supporting toxicology Locked 13-week and Phase 2-supporting toxicology
Human translational pharmacology Locked Human translational pharmacology
Phase 1 SAD/MAD first-in-human study Locked Phase 1 SAD/MAD first-in-human study E P
Whole-blood pSTAT target engagement Locked
Phase 1b ulcerative-colitis proof-of-pharmacology Locked Phase 1b ulcerative-colitis proof-of-pharmacology P S P
Phase 2b induction and maintenance study Locked Phase 2b induction and maintenance study P S P S
Week 12 induction clinical remission Locked
Week 52 maintenance clinical remission Locked
FDA 30-day IND safety review Locked
Original IND submission Locked
IND study may proceed Locked
Phase 2b protocol amendment Locked
EOP2 alignment documented Locked
FDA Type B Pre-IND Meeting Locked FDA Type B Pre-IND Meeting
FDA Type C Phase 2 Alignment Meeting Locked FDA Type C Phase 2 Alignment Meeting
FDA Type B End-of-Phase-2 Meeting Locked FDA Type B End-of-Phase-2 Meeting
Target Patient Value Proposition Locked
Induction clinical remission Locked
Durable maintenance of remission Locked
Once-daily oral regimen Locked
JAK1-biased therapeutic window Locked
Functional JAK1 bias translates clinically Locked
Serious and opportunistic infection Locked
Major cardiovascular events and venous thromboembolism Locked
JAK2-associated hematologic toxicity Locked
Formulation or CMC bridge failure Locked
Phase 2 can identify a single benefit-risk dose Locked
Restricted-line initial indication Locked
Lower-dose or shorter-exposure strategy Locked
Program stop or mechanism pivot Locked
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