
After Astra’s failure lupus attention turns to Aurinia
Today’s phase III flop of Astrazeneca’s anifrolumab makes Aurinia’s voclosporin the next lupus asset with a near-term pivotal readout. Aurora, Aurinia’s phase III trial in lupus nephritis, is to complete enrolment in the next quarter, and could yield data towards the end of 2019. Anifrolumab flunked the first of two pivotal systemic lupus erythematosus studies, Tulip-1, failing to show an effect on four-point SLE responder index improvement at 12 months versus placebo. As such, chances of success in Tulip-2, which has a similar design but tests only 300mg rather than three anifrolumab doses, are slim. Another lupus player to watch is the French micro-cap group Neovacs, which claimed a phase II win last month. However, close inspection of the data on Neovacs’ IFNα-Kinoid revealed a primary endpoint miss, and a hit in reducing an interferon signature. Aniforolumab was also being developed with an interferon gene signature test, and Neovacs’ hopes hinge on attracting a partner to fund phase III. For investors who have faith in Neovacs there is a further cautionary tale from Astra: anifrolumab at 300mg succeeded in phase II, but the effect vanished in the more rigorous pivotal setting.
Selected clinical projects for treating lupus | |||
---|---|---|---|
Project | Company | Mechanism | Trial ID |
Phase III | |||
Voclosporin | Aurinia Pharmaceuticals | Calcineurin inhibitor | NCT03597464 |
Olumiant | Lilly | Jak1 & 2 inhibitor | NCT03616912 |
Stelara | Bristol-Myers Squibb | IL-12 antibody; IL-23 receptor antibody | NCT03517722 |
Phase II | |||
XmAb5871 | Xencor | CD19 antibody | NCT02725515 |
CC-220 (iberdomide) | Celgene | Immunomodulator | NCT03161483 |
Filgotinib + GS-9876 | Galapagos/Gilead | Jak1 inhibitor + Syk inhibitor | NCT03134222 |
BI 655064 | Boehringer Ingelheim/Abbvie | TNFRSF5 antibody | NCT02770170 |
Evobrutinib | Merck KGaA | BTK inhibitor | NCT02975336 |
Gazyva | Roche | CD20 antibody | NCT02550652 |
Fenebrutinib | Roche | BTK inhibitor | NCT02908100 |
RSLV-132 | Takeda/Resolve Therapeutics | IFN alpha inhibitor | NCT02660944 |
Dapirolizumab | Biogen/UCB | TNF ligand superfamily 5 antibody | NCT02804763 |
BIIB059 | Biogen | BDAC2 antibody | NCT02847598 |
IFNα-Kinoid | Neovacs | Anti-interferon alpha vaccine | NCT02665364 |
ILT-101 | Iltoo Pharma | IL-2 regulator | NCT02955615 |
Lenabasum | Corbus Pharmaceuticals | CB2 agonist | NCT03093402 |
CFZ533 | Novartis | TNFRSF5 antibody | NCT03610516 |
Source: EvaluatePharma. |