After Astra’s failure lupus attention turns to Aurinia

Snippets

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.

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