Modality
Fusion Protein
MOA
CAR-T CD19
Target
AHR
Pathway
Fibrosis
ALS
Development Pipeline
Preclinical
~Apr 2015
→ ~Jul 2016
Phase 1
~Oct 2016
→ ~Jan 2018
Phase 2
~Apr 2018
→ ~Jul 2019
Phase 3
Oct 2019
→ May 2029
Phase 3Current
NCT03238978
846 pts·ALS
2019-10→2029-05·Completed
846 total pts1 indication
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (1)
2029-05-153.1y awayPh3 Readout· ALS
Trial Timeline
Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3
P3
Complet…
Catalysts
Ph3 Readout
2029-05-15 · 3.1y away
ALS
Completed|StartCompletionToday
Trials (1)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT03238978 | Phase 3 | ALS | Completed | 846 | VA |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| PFE-2901 | Pfizer | Phase 2 | AHR | |
| RHH-1546 | Roche | Phase 2/3 | C5 | |
| Datoglumide | AbbVie | Approved | CFTR | |
| AZN-1715 | AstraZeneca | Phase 3 | AHR | |
| BAY-6520 | Bayer | Phase 2 | AHR | |
| GIL-2259 | Gilead Sciences | Approved | SMN2 | |
| BII-4342 | Biogen | Phase 2/3 | CGRP | |
| Talasotorasib | Exelixis | Preclinical | APOC3 | |
| Semasacituzumab | Jazz Pharma | Phase 2 | AHR | |
| Doxalemzoparlimab | Nuvalent | Approved | AHR |