Aurinia (AUPH) received approval for oral agent Lupkynis/Voclosporin in Lupus Nephrtitis (LN) on 25Jan2021. GSK's Benlysta/Belimumab monoclonal antibody was approved in LN on 17Dec2020 adding to its prior approval in Systemic Lupus Erythematosis (SLE). The scientific team at AUPH has previously developed standard-of-care (SOC) LN therapeutic MMF. Lupkynis on top of SOC delivers excellent durable benefit with the original Phase III at 52 weeks, subsequent impressive interim extension study results at 2 years with an additional year expected by year-end.
The founder CEO retired and seasoned veteran Peter Greenleaf was brought in Mar2018 with previous C-suite experience as CEO of Cerecor and Sucampo, sold to Mallinckrodt. He brought in a highly experienced Chief Commercial Officer (CCO) with significant rare disease launch experience. They are very clear communicators, which helped the Street better understand how to think about launch dynamics. Otsuka is partnered for ex-US, as they articulated as a strategy. While some early stage business development has been done, Lupkynis is the big value driver.
BMY has been investing in the Lupus space. with Phase II PAISLEY trials for oral TYK-2 Deucra reading out first in SLE, then later in LN. Note this is reflected in the 2022/2023 Key Milestones on the Execution Scorecard updated during the 2Q2021 earnings call.
There is another oral compound, BMS-986256, in Phase II currently with a Primary Data Complete Date of May2024.
The purpose of this study is to evaluate the effectiveness, safety and tolerability of BMS-986256 in participants with active SLE.
Condition or disease
Systemic Lupus Erythematosus
Drug: BMS-986256 (Oral)Other: Placebo
Study Type :
Interventional (Clinical Trial)
Estimated Enrollment :
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
A Phase 2, Multicenter, Randomized, Double-blind, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of BMS-986256 in Participants With Active Systemic Lupus Erythematosus
Estimated Study Start Date :
June 30, 2021
Estimated Primary Completion Date :
May 1, 2024
Estimated Study Completion Date :
May 2, 2024
Iberdomide/CC-220 was also examined in SLE, however, it does not appear to be a priority with far more interesting Life Cycle Management (LCM) opportunities in hematological malignancies with Phase III combination trials already underway in earlier lines of RRMM.