Modality
Gene Therapy
MOA
FcRni
Target
PSMA
Pathway
Fibrosis
IPFGACeliac
Development Pipeline
Preclinical
~Sep 2014
→ ~Dec 2015
Phase 1
~Mar 2016
→ ~Jun 2017
Phase 2
~Sep 2017
→ ~Dec 2018
Phase 3
Mar 2019
→ Apr 2030
Phase 3Current
NCT04463927
1,185 pts·Celiac
2019-03→2030-04·Not yet recruiting
NCT07411471
2,960 pts·IPF
2019-03→2027-06·Recruiting
4,145 total pts2 indications
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (2)
2027-06-261.2y awayPh3 Readout· IPF
2030-04-264.1y awayPh3 Readout· Celiac
Trial Timeline
2019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3
P3
Not yet…
P3
Recruit…
Catalysts
Ph3 Readout
2027-06-26 · 1.2y away
IPF
Ph3 Readout
2030-04-26 · 4.1y away
Celiac
RecruitingNot yet recruiting|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT04463927 | Phase 3 | Celiac | Not yet recr... | 1185 | 6MWD |
| NCT07411471 | Phase 3 | IPF | Recruiting | 2960 | PASI75 |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| ABB-2476 | AbbVie | Phase 1/2 | USP1 | |
| AZN-3724 | AstraZeneca | Preclinical | PSMA | |
| Doxacagene | Sanofi | Approved | PSMA | |
| Suracagene | GSK | Phase 3 | PRMT5 | |
| GSK-2051 | GSK | Phase 1 | PSMA | |
| GIL-2445 | Gilead Sciences | Phase 2/3 | PSMA | |
| REG-6699 | Regeneron | Phase 2/3 | TIM-3 | |
| BII-1564 | Biogen | Phase 2 | PSMA | |
| BGN-3859 | BeiGene | Approved | PSMA | |
| Zanufutibatinib | Intra-Cellular | NDA/BLA | CD38 |