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.

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