(By Balaseshan) Eli Lilly & Co. (NYSE: LLY) said it will discontinue one of three Phase 3 rheumatoid arthritis (RA) registration studies of tabalumab, an anti-BAFF monoclonal antibody, due to insufficient efficacy.
The decision followed a planned interim futility analysis of the FLEX-M study investigating tabalumab, also known as LY2127399, for the treatment of patients with moderate-to-severe RA who had an inadequate response to methotrexate therapy.
The decision was not based on safety concerns, and patients currently enrolled in other tabalumab RA studies will continue treatment.
The decision to stop the FLEX-M study is expected to result in a fourth-quarter charge in the range of $20 million to $35 million (pre-tax), or about $0.02 per share (after-tax). The company's previously issued financial guidance for 2012 remains unchanged.
The FLEX-M study was designed to support registration of tabalumab as a potential treatment for RA, including an assessment of its effect on structural progression. Lilly continues to evaluate tabalumab in two other Phase 3 RA registration studies as well as an open-label extension study and several other smaller studies.
Lilly is suspending enrollment of new patients in the RA program until additional analysis from other ongoing RA studies is completed in early 2013. These other studies are in different patient populations.
Phase 3 studies for systemic lupus erythematosus are ongoing and will continue to enroll new patients. Currently, there is no evidence to suggest that efficacy results from the FLEX-M study in RA are indicative of potential efficacy in the lupus population. Lilly remains committed to the ongoing Phase 3 lupus program.
Tabalumab is a human immunoglobulin G subclass 4 (IgG4) monoclonal antibody (MAb) that inhibits both membrane-bound and soluble B cell activating factor (BAFF). Tabalumab is currently in Phase 3 development as a potential treatment for rheumatoid arthritis and systemic lupus erythematosus.
Lilly currently has a number of unique potential medicines in its Phase 3 clinical development pipeline, representing a variety of therapeutic areas including diabetes (four), cancer (three), neuroscience (two), autoimmunity (three) and cardiovascular (one).
LLY is trading up 0.14% at $49.07 on Thursday. The stock has been trading between $38.30 and $53.99 for the past 52 weeks.