← Pipeline|AFF-3518

AFF-3518

Phase 1
Source: Trial-derived·Trials: 1
Modality
Gene Therapy
MOA
JAK1/2i
Target
HER2
Pathway
Epigenetic
CeliacALSPBC
Development Pipeline
Preclinical
~Dec 2020
~Mar 2022
Phase 1
Jun 2022
Apr 2028
Phase 1Current
NCT03415865
810 pts·PBC
2022-062028-04·Not yet recruiting
810 total pts1 indication
Phase 2
Phase 3
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (1)
2028-04-032.0y awayInterim· PBC
Trial Timeline
Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2
P1
Not yet…
Catalysts
Interim
2028-04-03 · 2.0y away
PBC
Not yet recruiting|StartCompletionToday
Trials (1)
NCTPhaseIndicationStatusNEP
NCT03415865Phase 1PBCNot yet recr...810Mayo
Competitors (10)
DrugCompanyPhaseTargetMOA
FixanesiranAbbViePreclinicalRETJAK1/2i
GozesotorasibBristol-Myers SquibbNDA/BLAHER2IL-13i
MotavorutinibAmgenPhase 3CDK4/6JAK1/2i
VRT-4938Vertex PharmaPreclinicalHER2CDK4/6i
VRT-9481Vertex PharmaPhase 1/2MeninJAK1/2i
SovarelsinBioMarinPhase 2CFTRJAK1/2i
PeminaritideSareptaNDA/BLAPLK4JAK1/2i
NiramavacamtenHansoh PharmaPhase 2SGLT2JAK1/2i
ROI-9675Roivant SciencesNDA/BLAHER2USP1i
TalazumabZealand PharmaPhase 1/2WEE1JAK1/2i