Modality
Gene Therapy
MOA
KIF18Ai
Target
Aβ
Pathway
DDR
Asthma
Development Pipeline
Preclinical
~Jan 2013
→ ~Apr 2014
Phase 1
~Jul 2014
→ ~Oct 2015
Phase 2
~Jan 2016
→ ~Apr 2017
Phase 3
Jul 2017
→ Mar 2030
Phase 3Current
NCT05167162
1,385 pts·Asthma
2024-08→2030-03·Completed
NCT06578825
2,992 pts·Asthma
2024-11→2028-11·Not yet recruiting
NCT07783922
1,754 pts·Asthma
2017-07→2028-03·Completed
6,131 total pts1 indication
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (3)
2028-03-162.0y awayPh3 Readout· Asthma
2028-11-132.6y awayPh3 Readout· Asthma
2030-03-224.0y awayPh3 Readout· Asthma
Trial Timeline
Q2Q3Q42018Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2
P3
Complet…
P3
Complet…
P3
Not yet…
Catalysts
Ph3 Readout
2028-03-16 · 2.0y away
Asthma
Ph3 Readout
2028-11-13 · 2.6y away
Asthma
Ph3 Readout
2030-03-22 · 4.0y away
Asthma
CompletedNot yet recruiting|StartCompletionToday
Trials (3)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT05167162 | Phase 3 | Asthma | Completed | 1385 | PANSS |
| NCT06578825 | Phase 3 | Asthma | Not yet recr... | 2992 | DOR |
| NCT07783922 | Phase 3 | Asthma | Completed | 1754 | ACR20 |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Sotovorutinib | Pfizer | Approved | Aβ | |
| Ribosacituzumab | Roche | Approved | Cl18.2 | |
| RHH-8482 | Roche | Phase 1 | BTK | |
| Pexatenlimab | Novartis | Phase 1/2 | GPRC5D | |
| Bemalucimab | Bristol-Myers Squibb | Phase 1/2 | Aβ | |
| Datobrutinib | Sanofi | Phase 3 | Aβ | |
| TAK-1836 | Takeda | Preclinical | EGFR | |
| DSN-791 | Daiichi Sankyo | NDA/BLA | Aβ | |
| VRT-5853 | Vertex Pharma | Phase 3 | Aβ | |
| ARG-314 | Argenx | Approved | Aβ |