Modality
Cell Therapy
MOA
KIF18Ai
Target
SMN2
Pathway
Notch
Wet AMD
Development Pipeline
Preclinical
~Feb 2016
→ ~May 2017
Phase 1
~Aug 2017
→ ~Nov 2018
Phase 2
Feb 2019
→ Mar 2031
Phase 2Current
NCT07895492
2,984 pts·Wet AMD
2019-11→2029-10·Active
NCT08432736
2,917 pts·Wet AMD
2019-02→2031-03·Not yet recruiting
5,901 total pts1 indication
Phase 3
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (2)
2029-10-053.5y awayPh3 Readout· Wet AMD
2031-03-135.0y awayPh3 Readout· Wet AMD
Trial Timeline
2019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q42031Q2
P2/3
Not yet…
P2/3
Active
Catalysts
Ph3 Readout
2029-10-05 · 3.5y away
Wet AMD
Ph3 Readout
2031-03-13 · 5.0y away
Wet AMD
ActiveNot yet recruiting|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT07895492 | Phase 2/3 | Wet AMD | Active | 2984 | EFS |
| NCT08432736 | Phase 2/3 | Wet AMD | Not yet recr... | 2917 | EDSS |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| PFE-7550 | Pfizer | Phase 3 | Aβ | |
| Ribosacituzumab | Roche | Approved | Cl18.2 | |
| RHH-8482 | Roche | Phase 1 | BTK | |
| Pexatenlimab | Novartis | Phase 1/2 | GPRC5D | |
| NVO-6275 | Novo Nordisk | Phase 1 | SMN2 | |
| TAK-1836 | Takeda | Preclinical | EGFR | |
| TAK-5300 | Takeda | Phase 1 | SMN2 | |
| GIL-2259 | Gilead Sciences | Approved | SMN2 | |
| REG-647 | Regeneron | Preclinical | SMN2 | |
| Fixaglumide | Genmab | Phase 2/3 | WEE1 |