Modality
mAb
MOA
BiTE
Target
CFTR
Pathway
T-cell
MesoMDS
Development Pipeline
Preclinical
~Oct 2014
→ ~Jan 2016
Phase 1
~Apr 2016
→ ~Jul 2017
Phase 2
~Oct 2017
→ ~Jan 2019
Phase 3
Apr 2019
→ Oct 2030
Phase 3Current
NCT08527517
492 pts·Meso
2019-04→2029-10·Recruiting
NCT07994325
1,096 pts·MDS
2024-04→2030-10·Not yet recruiting
1,588 total pts2 indications
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (2)
2029-10-123.5y awayPh3 Readout· Meso
2030-10-194.6y awayPh3 Readout· MDS
Trial Timeline
Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q4
P3
Recruit…
P3
Not yet…
Catalysts
Ph3 Readout
2029-10-12 · 3.5y away
Meso
Ph3 Readout
2030-10-19 · 4.6y away
MDS
RecruitingNot yet recruiting|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT08527517 | Phase 3 | Meso | Recruiting | 492 | EASI-75 |
| NCT07994325 | Phase 3 | MDS | Not yet recr... | 1096 | CR |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Nidasacituzumab | Eli Lilly | Approved | CFTR | |
| LLY-3251 | Eli Lilly | Phase 2 | MDM2 | |
| Datoglumide | AbbVie | Approved | CFTR | |
| Zanutinib | Bristol-Myers Squibb | Phase 2/3 | APOC3 | |
| SNY-7254 | Sanofi | Phase 2 | CFTR | |
| SNY-5894 | Sanofi | Approved | CFTR | |
| Bemarelsin | Daiichi Sankyo | Preclinical | GLP-1R | |
| DSN-7360 | Daiichi Sankyo | Approved | SGLT2 | |
| BII-8315 | Biogen | NDA/BLA | CDK2 | |
| Sovarelsin | BioMarin | Phase 2 | CFTR |