Modality
Gene Therapy
MOA
Anti-Tau
Target
CD3
Pathway
RNA Splicing
DMDFSGSIgAN
Development Pipeline
Preclinical
~Aug 2016
→ ~Nov 2017
Phase 1
~Feb 2018
→ ~May 2019
Phase 2
Aug 2019
→ Apr 2031
Phase 2Current
NCT04637436
2,108 pts·IgAN
2020-10→2027-06·Terminated
NCT08287400
217 pts·IgAN
2019-08→2031-04·Recruiting
2,325 total pts1 indication
Phase 3
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (2)
2027-06-091.2y awayPh2 Data· IgAN
2031-04-155.0y awayPh2 Data· IgAN
Trial Timeline
Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q42031Q2Q3
P2
Recruit…
P2
Termina…
Catalysts
Ph2 Data
2027-06-09 · 1.2y away
IgAN
Ph2 Data
2031-04-15 · 5.0y away
IgAN
RecruitingTerminated|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT04637436 | Phase 2 | IgAN | Terminated | 2108 | EFS |
| NCT08287400 | Phase 2 | IgAN | Recruiting | 217 | BodyWt |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| RHH-7558 | Roche | Phase 1 | SGLT2 | |
| NVS-5439 | Novartis | Preclinical | BET | |
| SNY-4496 | Sanofi | Phase 2/3 | CD3 | |
| REG-2172 | Regeneron | Phase 1/2 | PCSK9 | |
| Miriglumide | Alnylam | Phase 3 | CD3 | |
| BGN-3305 | BeiGene | Phase 2 | BCMA | |
| Sovarasimod | Halozyme | Phase 1/2 | WEE1 | |
| Talatuximab | Samsung Biologics | Preclinical | CD3 | |
| MDG-4513 | Madrigal Pharma | Phase 1/2 | CD3 | |
| Voxamavacamten | Corcept | Approved | BET |