June 2, 2022
The Lupus Research Alliance (LRA) and its clinical trial arm Lupus Therapeutics congratulate Bristol Myers Squibb (BMS) on new positive results presented at the European Alliance of Associations for Rheumatology (EULAR) 2022 Congress from a Phase 2 trial of its investigational biologic deucravacitinib for the treatment of systemic lupus erythematosus (SLE).
Deucravacitinib is a potentially first-in-class inhibitor of Tyrosine kinase 2 (TYK2), which regulates the levels of two specific Type I interferons. Studies have shown that more than half of adults and most children with lupus have higher than normal levels of interferon.
Data presented at EULAR showed that the primary endpoint for evaluating the effectiveness of deucravacitinib was met; a significantly greater percentage of patients treated with the study drug met the required reduction of symptoms as evaluated by the SLE Responder Index (SRI), a composite measurement using scores from three widely accepted tools (58.2% of patients taking deucravacitinib versus 34.4% on placebo). At 48 weeks, those patients given deucravacitinib at an oral dose of 3 mg twice daily showed statistically significant reduction in symptoms according to four objective measurements. Similar rates of side effects were seen among those patients given deucravacitinib compared with those receiving placebo.
“This global phase 2 trial provides strong evidence that Tyk2, a kinase involved in interferon and IL12/23 signaling, is important in the pathogenesis of lupus,” noted the study’s principal investigator Professor Eric Morand, Head of the School of Clinical Sciences at Monash Health, Monash University in Australia and LRA Distinguished Innovator Award recipient. “An oral agent that targets the interferon pathway could be a game changer in the treatment of lupus. Translating success in phase 2 into success in phase 3 has been very challenging in SLE, but I look forward to seeing future results that might support registration of this medicine.”
Albert Roy, Executive Director of Lupus Therapeutics commented, “These are very encouraging results for patients with SLE. We are honored to have played a role in this exciting work by helping to conduct this clinical trial through our Lupus Clinical Investigators Network (LuCIN) of renowned North American academic centers. We thank BMS, all the investigators, and all the patients for their participation in this study evaluating what could provide a much-needed treatment option.”
“At Bristol Myers Squibb, we are committed to delivering pathbreaking science to elevate care for people living with serious diseases,” said Shalabh Singhal, Vice President and Development Program Lead, Bristol Myers Squibb. “We are proud of our collaboration with Lupus Therapeutics and its Lupus Clinical Investigator’s Network for our Phase 2 trial of deucravacitinib in systemic lupus erythematosus, which provided meaningful insights to help progress this important clinical trial.”
Positive Data on BIIB059 also Presented at EULAR
Data on another investigational drug, BIIB059 in development by Biogen, also showed effectiveness in inhibiting production of Type I interferons and other components of an overactive immune system. The results of the Phase 2 LILAC study met its primary endpoint in showing a reduction in symptoms of cutaneous lupus as evaluated by a standard measurement tool Cutaneous Lupus Erythematosus Disease Area and Severity Index – Activity (CLASI-A). Study investigators concluded that these results further support the effectiveness of BIIB059 in treating cutaneous lupus.
In addition, nine prominent scientists presented results of studies funded by the Lupus Research Alliance that point to potential treatment approaches.